Trial Outcomes & Findings for Cannabidiol for Bilateral Total Knee Arthroplasty (NCT NCT04749628)
NCT ID: NCT04749628
Last Updated: 2026-05-26
Results Overview
Cumulative opioid usage over the first 72 hours after surgery. Measured in morphine equivalents (ME), a scale that measure opioid usage among all opioid medications
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
37 participants
Primary outcome timeframe
0-72 hours postoperatively
Results posted on
2026-05-26
Participant Flow
Participant milestones
| Measure |
Ora-sweet SF
Ora-sweet SF: Ora-sweet SF placebo
|
400mg Cannabidiol
cannabidiol: Epidiolex (cannabidiol) oral solution
|
800mg Cannabidiol
cannabidiol: Epidiolex (cannabidiol) oral solution
|
|---|---|---|---|
|
Overall Study
STARTED
|
13
|
12
|
12
|
|
Overall Study
COMPLETED
|
7
|
9
|
11
|
|
Overall Study
NOT COMPLETED
|
6
|
3
|
1
|
Reasons for withdrawal
| Measure |
Ora-sweet SF
Ora-sweet SF: Ora-sweet SF placebo
|
400mg Cannabidiol
cannabidiol: Epidiolex (cannabidiol) oral solution
|
800mg Cannabidiol
cannabidiol: Epidiolex (cannabidiol) oral solution
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
1
|
0
|
1
|
|
Overall Study
Lost to Follow-up
|
2
|
3
|
0
|
|
Overall Study
Screen fail after enrollment
|
1
|
0
|
0
|
|
Overall Study
Discontinued intervention
|
2
|
0
|
0
|
Baseline Characteristics
Cannabidiol for Bilateral Total Knee Arthroplasty
Baseline characteristics by cohort
| Measure |
Ora-sweet SF
n=12 Participants
Ora-sweet SF: Ora-sweet SF placebo
|
400mg Cannabidiol
n=12 Participants
cannabidiol: Epidiolex (cannabidiol) oral solution
|
800mg Cannabidiol
n=12 Participants
cannabidiol: Epidiolex (cannabidiol) oral solution
|
Total
n=36 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
60.7 years
STANDARD_DEVIATION 7.9 • n=20 Participants
|
60.0 years
STANDARD_DEVIATION 7.5 • n=32 Participants
|
61.0 years
STANDARD_DEVIATION 5.1 • n=64 Participants
|
60.6 years
STANDARD_DEVIATION 6.8 • n=50 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=20 Participants
|
8 Participants
n=32 Participants
|
7 Participants
n=64 Participants
|
16 Participants
n=50 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=20 Participants
|
4 Participants
n=32 Participants
|
5 Participants
n=64 Participants
|
20 Participants
n=50 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=20 Participants
|
2 Participants
n=32 Participants
|
2 Participants
n=64 Participants
|
6 Participants
n=50 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
10 Participants
n=20 Participants
|
9 Participants
n=32 Participants
|
10 Participants
n=64 Participants
|
29 Participants
n=50 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=20 Participants
|
1 Participants
n=32 Participants
|
0 Participants
n=64 Participants
|
1 Participants
n=50 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=20 Participants
|
0 Participants
n=32 Participants
|
0 Participants
n=64 Participants
|
0 Participants
n=50 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=20 Participants
|
1 Participants
n=32 Participants
|
1 Participants
n=64 Participants
|
2 Participants
n=50 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=20 Participants
|
0 Participants
n=32 Participants
|
0 Participants
n=64 Participants
|
0 Participants
n=50 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=20 Participants
|
3 Participants
n=32 Participants
|
0 Participants
n=64 Participants
|
5 Participants
n=50 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=20 Participants
|
8 Participants
n=32 Participants
|
10 Participants
n=64 Participants
|
24 Participants
n=50 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=20 Participants
|
0 Participants
n=32 Participants
|
0 Participants
n=64 Participants
|
0 Participants
n=50 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=20 Participants
|
0 Participants
n=32 Participants
|
1 Participants
n=64 Participants
|
5 Participants
n=50 Participants
|
|
Weight
|
91.7 kilograms
STANDARD_DEVIATION 14.8 • n=20 Participants
|
91.8 kilograms
STANDARD_DEVIATION 30.2 • n=32 Participants
|
86.2 kilograms
STANDARD_DEVIATION 22.2 • n=64 Participants
|
89.9 kilograms
STANDARD_DEVIATION 22.4 • n=50 Participants
|
|
Height
|
173.3 centimeters
STANDARD_DEVIATION 10.4 • n=20 Participants
|
170.3 centimeters
STANDARD_DEVIATION 16.5 • n=32 Participants
|
169.4 centimeters
STANDARD_DEVIATION 12.0 • n=64 Participants
|
171.1 centimeters
STANDARD_DEVIATION 12.8 • n=50 Participants
|
|
ASA Status
ASA Status 1
|
1 Participants
n=20 Participants
|
1 Participants
n=32 Participants
|
1 Participants
n=64 Participants
|
3 Participants
n=50 Participants
|
|
ASA Status
ASA Status 2
|
11 Participants
n=20 Participants
|
11 Participants
n=32 Participants
|
11 Participants
n=64 Participants
|
33 Participants
n=50 Participants
|
PRIMARY outcome
Timeframe: 0-72 hours postoperativelyPopulation: One participant in the Ora-sweet SF group was not included in the analysis due to screen failing after enrollment. Therefore, 12 patients in each group were included in the analysis.
Cumulative opioid usage over the first 72 hours after surgery. Measured in morphine equivalents (ME), a scale that measure opioid usage among all opioid medications
Outcome measures
| Measure |
Ora-sweet SF
n=12 Participants
Ora-sweet SF: Ora-sweet SF placebo
|
400mg Cannabidiol
n=12 Participants
cannabidiol: Epidiolex (cannabidiol) oral solution
|
800mg Cannabidiol
n=12 Participants
cannabidiol: Epidiolex (cannabidiol) oral solution
|
|---|---|---|---|
|
Cumulative Opioid Usage in First 72 Hours Postoperatively
|
209.0 Morphine Milligram Equivalents (MME)
Standard Deviation 72.6
|
144.0 Morphine Milligram Equivalents (MME)
Standard Deviation 77.1
|
203.2 Morphine Milligram Equivalents (MME)
Standard Deviation 88.5
|
SECONDARY outcome
Timeframe: 0, 1, 2, 3, 4, 6 hours after medication administrationPopulation: Reasons for discrepancy between analyzed and overall number analyzed: missed sample collection, missed during lab analysis One participant in the Ora-sweet SF group was not included in the analysis due to screen failing after enrollment. Therefore, 12 patients in each group were included in the analysis.
Levels of CBD in the blood. This is measured using blood draws and lab analysis.
Outcome measures
| Measure |
Ora-sweet SF
n=12 Participants
Ora-sweet SF: Ora-sweet SF placebo
|
400mg Cannabidiol
n=12 Participants
cannabidiol: Epidiolex (cannabidiol) oral solution
|
800mg Cannabidiol
n=12 Participants
cannabidiol: Epidiolex (cannabidiol) oral solution
|
|---|---|---|---|
|
Pharmacokinetics of CBD
0h CBD Levels
|
0.00 micromolar
Standard Deviation 0.00
|
0.00 micromolar
Standard Deviation 0.00
|
0.00 micromolar
Standard Deviation 0.00
|
|
Pharmacokinetics of CBD
1h CBD Levels
|
0.00 micromolar
Standard Deviation 0.00
|
0.22 micromolar
Standard Deviation 0.78
|
9.22 micromolar
Standard Deviation 14.26
|
|
Pharmacokinetics of CBD
2h CBD Levels
|
0.00 micromolar
Standard Deviation 0.00
|
9.04 micromolar
Standard Deviation 20.17
|
21.39 micromolar
Standard Deviation 41.76
|
|
Pharmacokinetics of CBD
3h CBD Levels
|
0.00 micromolar
Standard Deviation 0.00
|
30.07 micromolar
Standard Deviation 68.59
|
19.08 micromolar
Standard Deviation 31.98
|
|
Pharmacokinetics of CBD
4h CBD Levels
|
0.00 micromolar
Standard Deviation 0.00
|
23.69 micromolar
Standard Deviation 31.71
|
31.28 micromolar
Standard Deviation 44.80
|
|
Pharmacokinetics of CBD
6h CBD Levels
|
0.00 micromolar
Standard Deviation 0.00
|
12.26 micromolar
Standard Deviation 17.36
|
34.39 micromolar
Standard Deviation 60.86
|
|
Pharmacokinetics of CBD
0h 6-OH-CBD Levels
|
0.00 micromolar
Standard Deviation 0.00
|
0.00 micromolar
Standard Deviation 0.00
|
0.00 micromolar
Standard Deviation 0.00
|
|
Pharmacokinetics of CBD
1h 6-OH-CBD Levels
|
0.00 micromolar
Standard Deviation 0.00
|
8.47 micromolar
Standard Deviation 17.46
|
102.11 micromolar
Standard Deviation 153.15
|
|
Pharmacokinetics of CBD
2h 6-OH-CBD Levels
|
0.00 micromolar
Standard Deviation 0.00
|
37.79 micromolar
Standard Deviation 82.80
|
156.72 micromolar
Standard Deviation 291.56
|
|
Pharmacokinetics of CBD
3h 6-OH-CBD Levels
|
0.00 micromolar
Standard Deviation 0.00
|
89.49 micromolar
Standard Deviation 119.69
|
139.42 micromolar
Standard Deviation 233.89
|
|
Pharmacokinetics of CBD
4h 6-OH-CBD Levels
|
0.00 micromolar
Standard Deviation 0.00
|
126.81 micromolar
Standard Deviation 179.31
|
203.23 micromolar
Standard Deviation 187.82
|
|
Pharmacokinetics of CBD
6h 6-OH-CBD Levels
|
0.00 micromolar
Standard Deviation 0.00
|
116.48 micromolar
Standard Deviation 198.12
|
246.80 micromolar
Standard Deviation 331.84
|
|
Pharmacokinetics of CBD
0h 7-COOH-CBD Levels
|
0.00 micromolar
Standard Deviation 0.00
|
0.00 micromolar
Standard Deviation 0.00
|
0.00 micromolar
Standard Deviation 0.00
|
|
Pharmacokinetics of CBD
1h 7-COOH-CBD Levels
|
0.00 micromolar
Standard Deviation 0.00
|
0.00 micromolar
Standard Deviation 0.00
|
0.82 micromolar
Standard Deviation 1.16
|
|
Pharmacokinetics of CBD
2h 7-COOH-CBD Levels
|
0.00 micromolar
Standard Deviation 0.00
|
0.01 micromolar
Standard Deviation 0.03
|
2.49 micromolar
Standard Deviation 4.35
|
|
Pharmacokinetics of CBD
3h 7-COOH-CBD Levels
|
0.00 micromolar
Standard Deviation 0.00
|
1.00 micromolar
Standard Deviation 1.36
|
3.60 micromolar
Standard Deviation 6.35
|
|
Pharmacokinetics of CBD
4h 7-COOH-CBD Levels
|
0.00 micromolar
Standard Deviation 0.00
|
2.76 micromolar
Standard Deviation 4.13
|
6.17 micromolar
Standard Deviation 8.34
|
|
Pharmacokinetics of CBD
6h 7-COOH-CBD Levels
|
0.00 micromolar
Standard Deviation 0.00
|
4.53 micromolar
Standard Deviation 8.15
|
10.72 micromolar
Standard Deviation 7.88
|
SECONDARY outcome
Timeframe: Preoperative, Postoperative day 1Population: One participant in the Ora-sweet SF group was not included in the analysis due to screen failing after enrollment. Therefore, 12 patients in each group were included in the analysis.
Interleukin-6 (IL6) is an inflammatory marker found in plasma. The levels of IL6 are measured using blood draws and lab analysis. The outcome measure below indicates the difference between IL6 levels on postoperative day 1 and preoperative.
Outcome measures
| Measure |
Ora-sweet SF
n=12 Participants
Ora-sweet SF: Ora-sweet SF placebo
|
400mg Cannabidiol
n=11 Participants
cannabidiol: Epidiolex (cannabidiol) oral solution
|
800mg Cannabidiol
n=11 Participants
cannabidiol: Epidiolex (cannabidiol) oral solution
|
|---|---|---|---|
|
Levels of Plasma Inflammatory Marker Interleukin-6
|
12.3 picograms per milliliter
Standard Deviation 10.4
|
20.6 picograms per milliliter
Standard Deviation 24.0
|
17.7 picograms per milliliter
Standard Deviation 10.9
|
SECONDARY outcome
Timeframe: Preoperatively; postoperatively in the PACU, morning of postoperative day (POD) 1,2,3,4,7 and at 3 monthsPopulation: Reasons for discrepancy between analyzed and overall number analyzed: withdrawn or lost to follow-up, missed data collection One participant in the Ora-sweet SF group was not included in the analysis due to screen failing after enrollment. Therefore, 12 patients in each group were included in the analysis.
Pain at rest measured using numerical rating scale(NRS) from 0-10, with 0 being no pain at all to 10 being the worst pain imaginable.
Outcome measures
| Measure |
Ora-sweet SF
n=12 Participants
Ora-sweet SF: Ora-sweet SF placebo
|
400mg Cannabidiol
n=12 Participants
cannabidiol: Epidiolex (cannabidiol) oral solution
|
800mg Cannabidiol
n=12 Participants
cannabidiol: Epidiolex (cannabidiol) oral solution
|
|---|---|---|---|
|
NRS Pain at Rest
Preop Worst NRS Pain Score
|
7.0 scores on a scale
Interval 4.0 to 9.0
|
7.5 scores on a scale
Interval 7.0 to 8.0
|
7.5 scores on a scale
Interval 6.5 to 9.0
|
|
NRS Pain at Rest
PACU Worst NRS Pain Score
|
7.5 scores on a scale
Interval 7.0 to 8.0
|
5.0 scores on a scale
Interval 0.0 to 7.0
|
7.5 scores on a scale
Interval 7.0 to 8.5
|
|
NRS Pain at Rest
POD1 Worst NRS Pain Score
|
8.0 scores on a scale
Interval 6.0 to 9.0
|
7.0 scores on a scale
Interval 5.0 to 8.0
|
9.0 scores on a scale
Interval 7.5 to 9.5
|
|
NRS Pain at Rest
POD2 Worst NRS Pain Score
|
8.0 scores on a scale
Interval 7.0 to 9.5
|
5.0 scores on a scale
Interval 4.0 to 7.5
|
7.0 scores on a scale
Interval 7.0 to 9.0
|
|
NRS Pain at Rest
POD3 Worst NRS Pain Score
|
9.0 scores on a scale
Interval 7.0 to 9.0
|
5.5 scores on a scale
Interval 4.0 to 7.5
|
8.0 scores on a scale
Interval 6.0 to 10.0
|
|
NRS Pain at Rest
POD4 Worst NRS Pain Score
|
8.0 scores on a scale
Interval 6.0 to 9.0
|
5.5 scores on a scale
Interval 4.0 to 6.5
|
6.0 scores on a scale
Interval 6.0 to 8.0
|
|
NRS Pain at Rest
POD7 Worst NRS Pain Score
|
8.0 scores on a scale
Interval 6.0 to 9.0
|
6.5 scores on a scale
Interval 5.0 to 7.5
|
5.0 scores on a scale
Interval 5.0 to 9.0
|
|
NRS Pain at Rest
3 Month Worst NRS Pain Score
|
2.5 scores on a scale
Interval 1.0 to 4.0
|
3.0 scores on a scale
Interval 0.0 to 5.0
|
2.0 scores on a scale
Interval 0.0 to 4.0
|
|
NRS Pain at Rest
Preop Least NRS Pain Score
|
1.0 scores on a scale
Interval 0.0 to 3.0
|
3.5 scores on a scale
Interval 2.0 to 5.0
|
3.0 scores on a scale
Interval 2.0 to 4.5
|
|
NRS Pain at Rest
PACU Least NRS Pain Score
|
0.0 scores on a scale
Interval 0.0 to 0.0
|
0.0 scores on a scale
Interval 0.0 to 0.0
|
0.0 scores on a scale
Interval 0.0 to 0.0
|
|
NRS Pain at Rest
POD1 Least NRS Pain Score
|
2.5 scores on a scale
Interval 1.0 to 4.5
|
0.0 scores on a scale
Interval 0.0 to 4.0
|
3.5 scores on a scale
Interval 1.5 to 5.0
|
|
NRS Pain at Rest
POD2 Least NRS Pain Score
|
3.0 scores on a scale
Interval 2.5 to 4.5
|
1.5 scores on a scale
Interval 0.5 to 4.0
|
3.0 scores on a scale
Interval 1.0 to 4.0
|
|
NRS Pain at Rest
POD3 Least NRS Pain Score
|
3.0 scores on a scale
Interval 2.0 to 5.0
|
2.5 scores on a scale
Interval 0.0 to 3.5
|
3.0 scores on a scale
Interval 0.0 to 4.0
|
|
NRS Pain at Rest
POD4 Least NRS Pain Score
|
2.0 scores on a scale
Interval 0.0 to 4.0
|
2.5 scores on a scale
Interval 0.5 to 3.0
|
2.0 scores on a scale
Interval 0.0 to 4.0
|
|
NRS Pain at Rest
POD7 Least NRS Pain Score
|
2.0 scores on a scale
Interval 1.0 to 3.0
|
0.5 scores on a scale
Interval 0.0 to 3.0
|
3.0 scores on a scale
Interval 0.0 to 4.0
|
|
NRS Pain at Rest
3 Month Least NRS Pain Score
|
0.0 scores on a scale
Interval 0.0 to 0.0
|
0.0 scores on a scale
Interval 0.0 to 0.0
|
0.0 scores on a scale
Interval 0.0 to 1.0
|
|
NRS Pain at Rest
Preop Average NRS Pain Score
|
5.0 scores on a scale
Interval 2.0 to 7.0
|
5.5 scores on a scale
Interval 4.0 to 7.0
|
5.5 scores on a scale
Interval 3.0 to 7.0
|
|
NRS Pain at Rest
PACU Average NRS Pain Score
|
3.0 scores on a scale
Interval 2.0 to 4.0
|
0.5 scores on a scale
Interval 0.0 to 3.0
|
3.5 scores on a scale
Interval 2.5 to 4.5
|
|
NRS Pain at Rest
POD1 Average NRS Pain Score
|
5.0 scores on a scale
Interval 3.0 to 6.0
|
4.5 scores on a scale
Interval 2.0 to 6.0
|
6.0 scores on a scale
Interval 3.5 to 7.0
|
|
NRS Pain at Rest
POD2 Average NRS Pain Score
|
6.0 scores on a scale
Interval 4.5 to 6.0
|
4.0 scores on a scale
Interval 2.0 to 5.0
|
5.0 scores on a scale
Interval 4.0 to 7.0
|
|
NRS Pain at Rest
POD3 Average NRS Pain Score
|
6.0 scores on a scale
Interval 5.0 to 6.0
|
3.0 scores on a scale
Interval 2.5 to 4.5
|
5.0 scores on a scale
Interval 4.0 to 7.0
|
|
NRS Pain at Rest
POD4 Average NRS Pain Score
|
5.0 scores on a scale
Interval 3.0 to 6.0
|
4.0 scores on a scale
Interval 1.5 to 4.5
|
5.0 scores on a scale
Interval 4.0 to 6.0
|
|
NRS Pain at Rest
POD7 Average NRS Pain Score
|
4.0 scores on a scale
Interval 4.0 to 5.0
|
4.0 scores on a scale
Interval 3.0 to 4.0
|
4.0 scores on a scale
Interval 2.0 to 5.0
|
|
NRS Pain at Rest
3 Month Average NRS Pain Score
|
1.0 scores on a scale
Interval 0.0 to 2.0
|
1.0 scores on a scale
Interval 0.0 to 2.0
|
0.0 scores on a scale
Interval 0.0 to 1.0
|
SECONDARY outcome
Timeframe: Preoperatively; morning of postoperative day (POD) 1,2,3,4,7 and at 3 monthsPopulation: Reasons for discrepancy between analyzed and overall number analyzed: withdrawn or lost to follow-up, missed data collection, specific movement not performed by participant(s) One participant in the Ora-sweet SF group was not included in the analysis due to screen failing after enrollment. Therefore, 12 patients in each group were included in the analysis.
Pain with movement using numerical rating scale(NRS) from 0-10, with 0 being no pain at all to 10 being the worst pain imaginable.
Outcome measures
| Measure |
Ora-sweet SF
n=12 Participants
Ora-sweet SF: Ora-sweet SF placebo
|
400mg Cannabidiol
n=12 Participants
cannabidiol: Epidiolex (cannabidiol) oral solution
|
800mg Cannabidiol
n=12 Participants
cannabidiol: Epidiolex (cannabidiol) oral solution
|
|---|---|---|---|
|
NRS Pain With Movement
POD7 Average NRS Pain Score - Ambulation
|
4.0 score on a scale
Interval 2.0 to 5.0
|
2.5 score on a scale
Interval 0.0 to 3.0
|
5.0 score on a scale
Interval 2.0 to 6.0
|
|
NRS Pain With Movement
3 Month Average NRS Pain Score - Ambulation
|
1.0 score on a scale
Interval 0.0 to 2.0
|
0.0 score on a scale
Interval 0.0 to 2.0
|
0.0 score on a scale
Interval 0.0 to 0.0
|
|
NRS Pain With Movement
Preop Worst NRS Pain Score - Stairs
|
8.0 score on a scale
Interval 7.0 to 10.0
|
7.0 score on a scale
Interval 5.0 to 9.0
|
9.0 score on a scale
Interval 7.0 to 9.0
|
|
NRS Pain With Movement
POD1 Worst NRS Pain Score - Stairs
|
8.0 score on a scale
Interval 4.0 to 8.0
|
4.0 score on a scale
Interval 4.0 to 4.0
|
—
|
|
NRS Pain With Movement
POD2 Worst NRS Pain Score - Stairs
|
8.0 score on a scale
Interval 7.0 to 8.0
|
6.0 score on a scale
Interval 3.0 to 7.5
|
8.0 score on a scale
Interval 7.0 to 8.0
|
|
NRS Pain With Movement
POD3 Worst NRS Pain Score - Stairs
|
8.0 score on a scale
Interval 5.5 to 9.0
|
4.5 score on a scale
Interval 4.0 to 5.5
|
8.0 score on a scale
Interval 8.0 to 9.0
|
|
NRS Pain With Movement
POD4 Worst NRS Pain Score - Stairs
|
7.5 score on a scale
Interval 6.0 to 9.0
|
5.0 score on a scale
Interval 5.0 to 6.0
|
6.0 score on a scale
Interval 4.5 to 8.0
|
|
NRS Pain With Movement
POD7 Worst NRS Pain Score - Stairs
|
6.0 score on a scale
Interval 6.0 to 9.0
|
4.5 score on a scale
Interval 2.0 to 5.0
|
5.5 score on a scale
Interval 1.5 to 8.5
|
|
NRS Pain With Movement
3 Month Worst NRS Pain Score - Stairs
|
3.0 score on a scale
Interval 3.0 to 5.0
|
2.0 score on a scale
Interval 0.0 to 4.0
|
1.0 score on a scale
Interval 0.0 to 4.0
|
|
NRS Pain With Movement
Preop Least NRS Pain Score - Stairs
|
6.5 score on a scale
Interval 4.0 to 8.0
|
5.0 score on a scale
Interval 3.0 to 8.0
|
7.0 score on a scale
Interval 4.0 to 8.0
|
|
NRS Pain With Movement
POD1 Least NRS Pain Score - Stairs
|
4.0 score on a scale
Interval 3.0 to 4.0
|
3.0 score on a scale
Interval 3.0 to 3.0
|
—
|
|
NRS Pain With Movement
POD2 Least NRS Pain Score - Stairs
|
5.0 score on a scale
Interval 5.0 to 6.0
|
4.0 score on a scale
Interval 2.0 to 4.5
|
6.0 score on a scale
Interval 6.0 to 6.0
|
|
NRS Pain With Movement
POD3 Least NRS Pain Score - Stairs
|
5.5 score on a scale
Interval 5.0 to 7.5
|
3.5 score on a scale
Interval 2.5 to 4.5
|
7.0 score on a scale
Interval 7.0 to 8.0
|
|
NRS Pain With Movement
POD4 Least NRS Pain Score - Stairs
|
6.0 score on a scale
Interval 3.0 to 8.0
|
4.0 score on a scale
Interval 3.0 to 5.0
|
5.5 score on a scale
Interval 3.5 to 7.0
|
|
NRS Pain With Movement
POD7 Least NRS Pain Score - Stairs
|
5.0 score on a scale
Interval 2.0 to 5.0
|
3.5 score on a scale
Interval 0.0 to 4.0
|
3.5 score on a scale
Interval 1.5 to 5.5
|
|
NRS Pain With Movement
3 Month Least NRS Pain Score - Stairs
|
2.0 score on a scale
Interval 0.0 to 3.0
|
1.0 score on a scale
Interval 0.0 to 2.0
|
0.0 score on a scale
Interval 0.0 to 3.0
|
|
NRS Pain With Movement
Preop Average NRS Pain Score - Stairs
|
7.0 score on a scale
Interval 5.0 to 9.0
|
6.0 score on a scale
Interval 4.0 to 8.0
|
8.0 score on a scale
Interval 5.0 to 9.0
|
|
NRS Pain With Movement
POD1 Average NRS Pain Score - Stairs
|
6.0 score on a scale
Interval 4.0 to 6.0
|
3.0 score on a scale
Interval 3.0 to 3.0
|
—
|
|
NRS Pain With Movement
POD2 Average NRS Pain Score - Stairs
|
6.5 score on a scale
Interval 6.0 to 8.0
|
5.0 score on a scale
Interval 2.5 to 5.5
|
7.5 score on a scale
Interval 7.0 to 8.0
|
|
NRS Pain With Movement
POD3 Average NRS Pain Score - Stairs
|
7.0 score on a scale
Interval 5.5 to 8.5
|
4.0 score on a scale
Interval 3.0 to 5.0
|
8.0 score on a scale
Interval 7.0 to 8.0
|
|
NRS Pain With Movement
POD4 Average NRS Pain Score - Stairs
|
6.5 score on a scale
Interval 5.0 to 8.0
|
5.0 score on a scale
Interval 4.0 to 5.0
|
6.0 score on a scale
Interval 4.0 to 7.5
|
|
NRS Pain With Movement
POD7 Average NRS Pain Score - Stairs
|
5.0 score on a scale
Interval 4.0 to 7.0
|
3.5 score on a scale
Interval 2.0 to 4.0
|
4.5 score on a scale
Interval 1.5 to 6.5
|
|
NRS Pain With Movement
3 Month Average NRS Pain Score - Stairs
|
3.0 score on a scale
Interval 2.0 to 4.0
|
1.0 score on a scale
Interval 0.0 to 4.0
|
1.0 score on a scale
Interval 0.0 to 3.0
|
|
NRS Pain With Movement
POD1 Worst NRS Pain Score - Physical Therapy
|
8.5 score on a scale
Interval 7.5 to 9.5
|
7.0 score on a scale
Interval 4.5 to 8.0
|
6.5 score on a scale
Interval 6.0 to 8.5
|
|
NRS Pain With Movement
POD2 Worst NRS Pain Score - Physical Therapy
|
8.0 score on a scale
Interval 6.0 to 9.0
|
6.0 score on a scale
Interval 5.0 to 8.0
|
8.0 score on a scale
Interval 6.0 to 9.0
|
|
NRS Pain With Movement
POD3 Worst NRS Pain Score - Physical Therapy
|
8.5 score on a scale
Interval 6.5 to 9.0
|
5.0 score on a scale
Interval 4.0 to 6.5
|
8.0 score on a scale
Interval 8.0 to 9.0
|
|
NRS Pain With Movement
POD4 Worst NRS Pain Score - Physical Therapy
|
8.0 score on a scale
Interval 8.0 to 9.0
|
6.0 score on a scale
Interval 6.0 to 7.0
|
8.0 score on a scale
Interval 7.0 to 9.0
|
|
NRS Pain With Movement
POD7 Worst NRS Pain Score - Physical Therapy
|
7.0 score on a scale
Interval 6.5 to 7.5
|
6.0 score on a scale
Interval 5.0 to 8.0
|
7.5 score on a scale
Interval 5.0 to 9.0
|
|
NRS Pain With Movement
3 Month Worst NRS Pain Score - Physical Therapy
|
3.5 score on a scale
Interval 2.5 to 6.0
|
3.5 score on a scale
Interval 1.5 to 4.0
|
2.0 score on a scale
Interval 0.0 to 5.0
|
|
NRS Pain With Movement
POD1 Least NRS Pain Score - Physical Therapy
|
4.0 score on a scale
Interval 2.5 to 7.0
|
2.0 score on a scale
Interval 0.5 to 3.5
|
4.5 score on a scale
Interval 2.0 to 6.0
|
|
NRS Pain With Movement
POD2 Least NRS Pain Score - Physical Therapy
|
4.0 score on a scale
Interval 3.0 to 6.5
|
4.0 score on a scale
Interval 3.0 to 4.0
|
4.0 score on a scale
Interval 2.0 to 7.0
|
|
NRS Pain With Movement
POD3 Least NRS Pain Score - Physical Therapy
|
4.0 score on a scale
Interval 2.0 to 5.0
|
3.0 score on a scale
Interval 1.5 to 3.5
|
4.0 score on a scale
Interval 1.0 to 5.0
|
|
NRS Pain With Movement
POD4 Least NRS Pain Score - Physical Therapy
|
5.0 score on a scale
Interval 2.0 to 6.0
|
2.0 score on a scale
Interval 0.0 to 3.0
|
3.0 score on a scale
Interval 0.0 to 5.0
|
|
NRS Pain With Movement
POD7 Least NRS Pain Score - Physical Therapy
|
3.0 score on a scale
Interval 1.5 to 5.0
|
3.0 score on a scale
Interval 1.0 to 4.0
|
4.5 score on a scale
Interval 3.0 to 6.0
|
|
NRS Pain With Movement
3 Month Least NRS Pain Score - Physical Therapy
|
1.5 score on a scale
Interval 0.0 to 3.0
|
0.0 score on a scale
Interval 0.0 to 1.0
|
0.0 score on a scale
Interval 0.0 to 0.0
|
|
NRS Pain With Movement
POD1 Average NRS Pain Score - Physical Therapy
|
6.0 score on a scale
Interval 5.5 to 8.0
|
4.0 score on a scale
Interval 3.0 to 6.0
|
5.5 score on a scale
Interval 4.5 to 7.5
|
|
NRS Pain With Movement
POD2 Average NRS Pain Score - Physical Therapy
|
5.5 score on a scale
Interval 4.5 to 7.5
|
5.0 score on a scale
Interval 4.0 to 6.0
|
6.0 score on a scale
Interval 4.0 to 8.0
|
|
NRS Pain With Movement
POD3 Average NRS Pain Score - Physical Therapy
|
6.0 score on a scale
Interval 4.0 to 7.0
|
4.0 score on a scale
Interval 3.0 to 5.0
|
6.0 score on a scale
Interval 6.0 to 7.0
|
|
NRS Pain With Movement
POD4 Average NRS Pain Score - Physical Therapy
|
6.0 score on a scale
Interval 5.0 to 7.0
|
4.0 score on a scale
Interval 3.0 to 5.0
|
5.0 score on a scale
Interval 4.0 to 7.0
|
|
NRS Pain With Movement
POD7 Average NRS Pain Score - Physical Therapy
|
4.5 score on a scale
Interval 4.0 to 6.5
|
3.5 score on a scale
Interval 2.0 to 5.0
|
5.0 score on a scale
Interval 5.0 to 7.5
|
|
NRS Pain With Movement
3 Month Average NRS Pain Score - Physical Therapy
|
1.5 score on a scale
Interval 1.0 to 3.5
|
2.0 score on a scale
Interval 0.0 to 3.0
|
0.0 score on a scale
Interval 0.0 to 2.0
|
|
NRS Pain With Movement
Preop Worst NRS Pain Score - Knee Flexion/Extension
|
7.0 score on a scale
Interval 6.0 to 9.0
|
7.0 score on a scale
Interval 4.5 to 8.5
|
5.5 score on a scale
Interval 2.0 to 7.5
|
|
NRS Pain With Movement
POD1 Worst NRS Pain Score - Knee Flexion/Extension
|
8.5 score on a scale
Interval 6.0 to 9.0
|
5.5 score on a scale
Interval 4.0 to 8.0
|
6.0 score on a scale
Interval 3.5 to 7.5
|
|
NRS Pain With Movement
POD2 Worst NRS Pain Score - Knee Flexion/Extension
|
7.0 score on a scale
Interval 6.5 to 9.0
|
6.0 score on a scale
Interval 5.0 to 6.0
|
8.0 score on a scale
Interval 6.0 to 10.0
|
|
NRS Pain With Movement
POD3 Worst NRS Pain Score - Knee Flexion/Extension
|
7.0 score on a scale
Interval 7.0 to 9.0
|
5.0 score on a scale
Interval 4.0 to 8.0
|
7.0 score on a scale
Interval 6.0 to 8.0
|
|
NRS Pain With Movement
POD4 Worst NRS Pain Score - Knee Flexion/Extension
|
8.0 score on a scale
Interval 6.0 to 9.0
|
5.5 score on a scale
Interval 2.5 to 6.0
|
6.5 score on a scale
Interval 5.0 to 8.0
|
|
NRS Pain With Movement
POD7 Worst NRS Pain Score - Knee Flexion/Extension
|
6.5 score on a scale
Interval 6.0 to 8.0
|
6.0 score on a scale
Interval 4.5 to 8.5
|
7.0 score on a scale
Interval 5.0 to 8.0
|
|
NRS Pain With Movement
3 Month Worst NRS Pain Score - Knee Flexion/Extension
|
2.5 score on a scale
Interval 1.0 to 5.0
|
2.0 score on a scale
Interval 0.0 to 5.0
|
2.0 score on a scale
Interval 0.0 to 4.0
|
|
NRS Pain With Movement
Preop Least NRS Pain Score - Knee Flexion/Extension
|
4.0 score on a scale
Interval 3.0 to 8.0
|
5.0 score on a scale
Interval 3.5 to 6.0
|
3.5 score on a scale
Interval 1.0 to 7.0
|
|
NRS Pain With Movement
POD1 Least NRS Pain Score - Knee Flexion/Extension
|
5.0 score on a scale
Interval 2.5 to 8.0
|
3.0 score on a scale
Interval 0.5 to 5.5
|
4.0 score on a scale
Interval 2.5 to 6.0
|
|
NRS Pain With Movement
POD2 Least NRS Pain Score - Knee Flexion/Extension
|
5.0 score on a scale
Interval 3.0 to 7.5
|
4.0 score on a scale
Interval 3.0 to 5.0
|
6.0 score on a scale
Interval 4.0 to 7.0
|
|
NRS Pain With Movement
POD3 Least NRS Pain Score - Knee Flexion/Extension
|
5.0 score on a scale
Interval 5.0 to 6.0
|
4.0 score on a scale
Interval 3.0 to 5.5
|
7.0 score on a scale
Interval 5.0 to 8.0
|
|
NRS Pain With Movement
POD4 Least NRS Pain Score - Knee Flexion/Extension
|
5.0 score on a scale
Interval 3.0 to 7.0
|
3.0 score on a scale
Interval 1.5 to 5.0
|
5.0 score on a scale
Interval 4.0 to 7.0
|
|
NRS Pain With Movement
POD7 Least NRS Pain Score - Knee Flexion/Extension
|
4.0 score on a scale
Interval 4.0 to 5.0
|
3.0 score on a scale
Interval 2.0 to 4.5
|
5.0 score on a scale
Interval 3.0 to 7.0
|
|
NRS Pain With Movement
3 Month Least NRS Pain Score - Knee Flexion/Extension
|
0.0 score on a scale
Interval 0.0 to 0.0
|
0.0 score on a scale
Interval 0.0 to 0.0
|
0.0 score on a scale
Interval 0.0 to 1.0
|
|
NRS Pain With Movement
Preop Average NRS Pain Score - Knee Flexion/Extension
|
5.0 score on a scale
Interval 5.0 to 8.0
|
5.5 score on a scale
Interval 4.5 to 7.0
|
4.5 score on a scale
Interval 2.0 to 7.5
|
|
NRS Pain With Movement
POD1 Average NRS Pain Score - Knee Flexion/Extension
|
6.5 score on a scale
Interval 4.0 to 9.0
|
5.0 score on a scale
Interval 2.5 to 6.0
|
5.5 score on a scale
Interval 3.0 to 7.0
|
|
NRS Pain With Movement
POD2 Average NRS Pain Score - Knee Flexion/Extension
|
6.5 score on a scale
Interval 5.0 to 8.5
|
5.0 score on a scale
Interval 4.0 to 5.0
|
7.0 score on a scale
Interval 5.0 to 7.0
|
|
NRS Pain With Movement
POD3 Average NRS Pain Score - Knee Flexion/Extension
|
6.5 score on a scale
Interval 5.0 to 7.0
|
5.0 score on a scale
Interval 3.0 to 6.5
|
7.0 score on a scale
Interval 5.0 to 8.0
|
|
NRS Pain With Movement
POD4 Average NRS Pain Score - Knee Flexion/Extension
|
5.0 score on a scale
Interval 5.0 to 8.0
|
4.0 score on a scale
Interval 2.0 to 5.5
|
6.0 score on a scale
Interval 5.0 to 7.0
|
|
NRS Pain With Movement
POD7 Average NRS Pain Score - Knee Flexion/Extension
|
5.0 score on a scale
Interval 4.0 to 7.0
|
4.5 score on a scale
Interval 3.5 to 5.5
|
5.0 score on a scale
Interval 5.0 to 7.0
|
|
NRS Pain With Movement
3 Month Average NRS Pain Score - Knee Flexion/Extension
|
1.0 score on a scale
Interval 0.0 to 2.0
|
1.0 score on a scale
Interval 0.0 to 2.0
|
1.0 score on a scale
Interval 0.0 to 4.0
|
|
NRS Pain With Movement
Preop Worst NRS Pain Score - Ambulation
|
7.5 score on a scale
Interval 6.0 to 9.0
|
7.0 score on a scale
Interval 5.5 to 7.5
|
7.0 score on a scale
Interval 4.5 to 7.5
|
|
NRS Pain With Movement
POD1 Worst NRS Pain Score - Ambulation
|
7.5 score on a scale
Interval 6.0 to 9.0
|
5.5 score on a scale
Interval 3.0 to 7.5
|
7.0 score on a scale
Interval 5.0 to 9.0
|
|
NRS Pain With Movement
POD2 Worst NRS Pain Score - Ambulation
|
6.5 score on a scale
Interval 5.0 to 8.5
|
5.5 score on a scale
Interval 4.0 to 7.0
|
4.5 score on a scale
Interval 3.0 to 7.0
|
|
NRS Pain With Movement
POD3 Worst NRS Pain Score - Ambulation
|
7.0 score on a scale
Interval 4.0 to 9.0
|
4.0 score on a scale
Interval 1.5 to 5.5
|
5.0 score on a scale
Interval 3.0 to 7.0
|
|
NRS Pain With Movement
POD4 Worst NRS Pain Score - Ambulation
|
6.0 score on a scale
Interval 5.0 to 9.0
|
4.0 score on a scale
Interval 1.5 to 5.5
|
5.0 score on a scale
Interval 2.0 to 7.0
|
|
NRS Pain With Movement
POD7 Worst NRS Pain Score - Ambulation
|
5.0 score on a scale
Interval 4.0 to 6.0
|
3.0 score on a scale
Interval 0.0 to 5.0
|
5.0 score on a scale
Interval 3.0 to 8.0
|
|
NRS Pain With Movement
3 Month Worst NRS Pain Score - Ambulation
|
2.5 score on a scale
Interval 0.0 to 4.0
|
0.0 score on a scale
Interval 0.0 to 3.0
|
0.0 score on a scale
Interval 0.0 to 0.0
|
|
NRS Pain With Movement
Preop Least NRS Pain Score - Ambulation
|
5.0 score on a scale
Interval 2.0 to 7.0
|
4.5 score on a scale
Interval 3.0 to 6.0
|
4.0 score on a scale
Interval 2.5 to 5.5
|
|
NRS Pain With Movement
POD1 Least NRS Pain Score - Ambulation
|
5.5 score on a scale
Interval 3.0 to 8.0
|
3.0 score on a scale
Interval 1.0 to 5.0
|
5.0 score on a scale
Interval 5.0 to 8.0
|
|
NRS Pain With Movement
POD2 Least NRS Pain Score - Ambulation
|
4.5 score on a scale
Interval 3.0 to 6.5
|
3.5 score on a scale
Interval 2.5 to 4.5
|
4.0 score on a scale
Interval 3.0 to 7.0
|
|
NRS Pain With Movement
POD3 Least NRS Pain Score - Ambulation
|
4.0 score on a scale
Interval 3.0 to 6.0
|
3.0 score on a scale
Interval 1.5 to 4.0
|
4.0 score on a scale
Interval 1.0 to 5.0
|
|
NRS Pain With Movement
POD4 Least NRS Pain Score - Ambulation
|
4.0 score on a scale
Interval 2.0 to 5.0
|
2.5 score on a scale
Interval 0.5 to 4.0
|
2.0 score on a scale
Interval 0.0 to 6.0
|
|
NRS Pain With Movement
POD7 Least NRS Pain Score - Ambulation
|
3.0 score on a scale
Interval 0.0 to 4.0
|
0.5 score on a scale
Interval 0.0 to 3.0
|
4.0 score on a scale
Interval 2.0 to 5.0
|
|
NRS Pain With Movement
3 Month Least NRS Pain Score - Ambulation
|
0.0 score on a scale
Interval 0.0 to 0.0
|
0.0 score on a scale
Interval 0.0 to 0.0
|
0.0 score on a scale
Interval 0.0 to 0.0
|
|
NRS Pain With Movement
Preop Average NRS Pain Score - Ambulation
|
6.0 score on a scale
Interval 5.0 to 8.0
|
5.0 score on a scale
Interval 4.0 to 6.5
|
5.0 score on a scale
Interval 4.0 to 6.5
|
|
NRS Pain With Movement
POD1 Average NRS Pain Score - Ambulation
|
6.5 score on a scale
Interval 4.5 to 8.5
|
4.0 score on a scale
Interval 2.0 to 6.0
|
6.0 score on a scale
Interval 5.0 to 8.0
|
|
NRS Pain With Movement
POD2 Average NRS Pain Score - Ambulation
|
5.5 score on a scale
Interval 4.0 to 7.5
|
4.0 score on a scale
Interval 3.0 to 5.0
|
4.0 score on a scale
Interval 3.0 to 7.0
|
|
NRS Pain With Movement
POD3 Average NRS Pain Score - Ambulation
|
5.0 score on a scale
Interval 3.0 to 7.0
|
3.5 score on a scale
Interval 1.5 to 4.5
|
5.0 score on a scale
Interval 2.0 to 7.0
|
|
NRS Pain With Movement
POD4 Average NRS Pain Score - Ambulation
|
5.0 score on a scale
Interval 4.0 to 6.0
|
3.0 score on a scale
Interval 1.0 to 4.5
|
3.0 score on a scale
Interval 2.0 to 6.0
|
SECONDARY outcome
Timeframe: Preoperatively; morning of postoperative day (POD) 1,2,3,4,7 and at 3 monthsPopulation: Reasons for discrepancy between analyzed and overall number analyzed: withdrawn or lost to follow-up, missed data collection One participant in the Ora-sweet SF group was not included in the analysis due to screen failing after enrollment. Therefore, 12 patients in each group were included in the analysis.
Brief Pain inventory short form measures the severity of pain and its impact on function. It measures pain from 0-10 0 being no pain whatsoever to 10 being the worst pain imaginable. It measures impact on function from 0-10, 0 being no impact whatsoever to 10 being completely impactful.
Outcome measures
| Measure |
Ora-sweet SF
n=12 Participants
Ora-sweet SF: Ora-sweet SF placebo
|
400mg Cannabidiol
n=12 Participants
cannabidiol: Epidiolex (cannabidiol) oral solution
|
800mg Cannabidiol
n=12 Participants
cannabidiol: Epidiolex (cannabidiol) oral solution
|
|---|---|---|---|
|
Brief Pain Inventory Short Form
Preop BPI-sf Pain Severity
|
4.3 units on a scale
Interval 2.0 to 7.0
|
5.1 units on a scale
Interval 4.4 to 6.4
|
4.8 units on a scale
Interval 3.4 to 6.5
|
|
Brief Pain Inventory Short Form
POD1 BPI-sf Pain Severity
|
4.9 units on a scale
Interval 3.4 to 6.0
|
4.3 units on a scale
Interval 1.9 to 6.0
|
6.4 units on a scale
Interval 4.4 to 6.6
|
|
Brief Pain Inventory Short Form
POD2 BPI-sf Pain Severity
|
5.3 units on a scale
Interval 4.8 to 6.3
|
3.6 units on a scale
Interval 2.0 to 5.5
|
5.3 units on a scale
Interval 4.0 to 6.5
|
|
Brief Pain Inventory Short Form
POD3 BPI-sf Pain Severity
|
5.5 units on a scale
Interval 5.0 to 6.0
|
3.6 units on a scale
Interval 2.1 to 4.4
|
5.0 units on a scale
Interval 3.3 to 6.0
|
|
Brief Pain Inventory Short Form
POD4 BPI-sf Pain Severity
|
4.5 units on a scale
Interval 3.5 to 5.8
|
4.3 units on a scale
Interval 1.4 to 4.6
|
3.8 units on a scale
Interval 3.3 to 5.5
|
|
Brief Pain Inventory Short Form
POD7 BPI-sf Pain Severity
|
4.3 units on a scale
Interval 4.3 to 4.8
|
3.6 units on a scale
Interval 2.8 to 4.5
|
4.0 units on a scale
Interval 2.0 to 5.3
|
|
Brief Pain Inventory Short Form
3 Month BPI-sf Pain Severity
|
0.9 units on a scale
Interval 0.3 to 1.8
|
1.0 units on a scale
Interval 0.0 to 1.8
|
0.5 units on a scale
Interval 0.0 to 2.0
|
|
Brief Pain Inventory Short Form
Preop BPI-sf Pain Interference
|
5.7 units on a scale
Interval 3.7 to 8.9
|
4.7 units on a scale
Interval 4.3 to 6.2
|
6.1 units on a scale
Interval 4.1 to 6.6
|
|
Brief Pain Inventory Short Form
POD1 BPI-sf Pain Interference
|
6.2 units on a scale
Interval 5.2 to 7.1
|
4.7 units on a scale
Interval 2.3 to 6.7
|
5.6 units on a scale
Interval 3.3 to 6.8
|
|
Brief Pain Inventory Short Form
POD2 BPI-sf Pain Interference
|
6.8 units on a scale
Interval 3.6 to 8.7
|
4.4 units on a scale
Interval 3.3 to 6.7
|
4.9 units on a scale
Interval 2.7 to 7.3
|
|
Brief Pain Inventory Short Form
POD3 BPI-sf Pain Interference
|
5.0 units on a scale
Interval 3.9 to 6.9
|
2.9 units on a scale
Interval 1.6 to 5.4
|
4.0 units on a scale
Interval 2.9 to 6.3
|
|
Brief Pain Inventory Short Form
POD4 BPI-sf Pain Interference
|
4.6 units on a scale
Interval 4.0 to 6.9
|
3.8 units on a scale
Interval 2.0 to 5.0
|
4.7 units on a scale
Interval 2.7 to 6.3
|
|
Brief Pain Inventory Short Form
POD7 BPI-sf Pain Interference
|
4.6 units on a scale
Interval 2.7 to 5.3
|
3.2 units on a scale
Interval 2.1 to 4.2
|
4.3 units on a scale
Interval 3.6 to 6.3
|
|
Brief Pain Inventory Short Form
3 Month BPI-sf Pain Interference
|
1.8 units on a scale
Interval 1.1 to 3.6
|
0.4 units on a scale
Interval 0.1 to 2.7
|
0.7 units on a scale
Interval 0.0 to 1.1
|
SECONDARY outcome
Timeframe: Postoperatively in the PACU; morning of postoperative day (POD) 1,2,3,4,7 and at 3 monthsPopulation: One participant in the Ora-sweet SF group was not included in the analysis due to screen failing after enrollment. Therefore, 12 patients in each group were included in the analysis. Reasons for discrepancy between analyzed and overall number analyzed: withdrawn or lost to follow-up, missed data collection
Adverse events, including allergic reactions, pyrexia (fever), somnolence (excessive sleepiness), GI problems (upset stomach, diarrhea), dry mouth, escalation of post-operative opioid requirement
Outcome measures
| Measure |
Ora-sweet SF
n=12 Participants
Ora-sweet SF: Ora-sweet SF placebo
|
400mg Cannabidiol
n=12 Participants
cannabidiol: Epidiolex (cannabidiol) oral solution
|
800mg Cannabidiol
n=12 Participants
cannabidiol: Epidiolex (cannabidiol) oral solution
|
|---|---|---|---|
|
Incidence of Adverse Events
Allergic reactions - POD2
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Adverse Events
Allergic reactions - POD3
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Adverse Events
Allergic reactions - POD4
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Adverse Events
Allergic reactions - POD7
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Adverse Events
Allergic reactions - 3 months
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Adverse Events
Pyrexia (fever) - Postoperatively in the PACU
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Adverse Events
Pyrexia (fever) - POD1
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Adverse Events
Pyrexia (fever) - POD2
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Adverse Events
Pyrexia (fever) - POD3
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Adverse Events
Pyrexia (fever) - POD4
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Adverse Events
Pyrexia (fever) - POD7
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Adverse Events
GI problems (upset stomach, diarrhea) - POD4
|
2 Participants
|
4 Participants
|
2 Participants
|
|
Incidence of Adverse Events
GI problems (upset stomach, diarrhea) - POD7
|
1 Participants
|
1 Participants
|
1 Participants
|
|
Incidence of Adverse Events
GI problems (upset stomach, diarrhea) - 3 months
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Adverse Events
Dry mouth - POD1
|
6 Participants
|
6 Participants
|
8 Participants
|
|
Incidence of Adverse Events
Dry mouth - POD2
|
5 Participants
|
6 Participants
|
9 Participants
|
|
Incidence of Adverse Events
Dry mouth - POD3
|
3 Participants
|
6 Participants
|
5 Participants
|
|
Incidence of Adverse Events
Dry mouth - POD4
|
2 Participants
|
4 Participants
|
6 Participants
|
|
Incidence of Adverse Events
Dry mouth - POD7
|
1 Participants
|
2 Participants
|
8 Participants
|
|
Incidence of Adverse Events
Dry mouth - 3 months
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Incidence of Adverse Events
Escalation of post-operative opioid requirement - IV hydromorphone, subcutaneous hydromorphone
|
10 Participants
|
4 Participants
|
11 Participants
|
|
Incidence of Adverse Events
Pyrexia (fever) - 3 months
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Adverse Events
Somnolence (excessive sleepiness) - POD1
|
5 Participants
|
3 Participants
|
8 Participants
|
|
Incidence of Adverse Events
Somnolence (excessive sleepiness) - POD2
|
7 Participants
|
6 Participants
|
8 Participants
|
|
Incidence of Adverse Events
Somnolence (excessive sleepiness) - POD3
|
4 Participants
|
5 Participants
|
7 Participants
|
|
Incidence of Adverse Events
Somnolence (excessive sleepiness) - POD4
|
5 Participants
|
5 Participants
|
6 Participants
|
|
Incidence of Adverse Events
Somnolence (excessive sleepiness) - POD7
|
7 Participants
|
3 Participants
|
7 Participants
|
|
Incidence of Adverse Events
Somnolence (excessive sleepiness) - 3 months
|
1 Participants
|
2 Participants
|
2 Participants
|
|
Incidence of Adverse Events
GI problems (upset stomach, diarrhea) - POD1
|
3 Participants
|
4 Participants
|
6 Participants
|
|
Incidence of Adverse Events
GI problems (upset stomach, diarrhea) - POD2
|
3 Participants
|
6 Participants
|
6 Participants
|
|
Incidence of Adverse Events
GI problems (upset stomach, diarrhea) - POD3
|
1 Participants
|
3 Participants
|
3 Participants
|
|
Incidence of Adverse Events
Allergic reactions - Postoperatively in the PACU
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Adverse Events
Allergic reactions - POD1
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Morning of postoperative day (POD) 1,2,3,4,7 and at 3 monthsPopulation: Reasons for discrepancy between analyzed and overall number analyzed: withdrawn or lost to follow-up, missed data collection One participant in the Ora-sweet SF group was not included in the analysis due to screen failing after enrollment. Therefore, 12 patients in each group were included in the analysis.
Opioid related Symptom Distress Scale (ORSDS) measures opioid related side effects. There are 12 side effects with 3 subcategories (severity, frequency, bothersomeness) each with 5 different responses (scored 0-4 with higher scores indicating worse symptoms). The ORSDS composite score was calculated by averaging the scores for each symptom.
Outcome measures
| Measure |
Ora-sweet SF
n=12 Participants
Ora-sweet SF: Ora-sweet SF placebo
|
400mg Cannabidiol
n=12 Participants
cannabidiol: Epidiolex (cannabidiol) oral solution
|
800mg Cannabidiol
n=12 Participants
cannabidiol: Epidiolex (cannabidiol) oral solution
|
|---|---|---|---|
|
Opioid Related Symptom Distress Scale (ORSDS)
POD1 ORSDS Composite Score
|
0.4 score on a scale
Interval 0.1 to 0.7
|
0.5 score on a scale
Interval 0.1 to 0.7
|
1.0 score on a scale
Interval 0.4 to 1.2
|
|
Opioid Related Symptom Distress Scale (ORSDS)
POD2 ORSDS Composite Score
|
0.4 score on a scale
Interval 0.2 to 0.6
|
0.5 score on a scale
Interval 0.2 to 0.9
|
0.7 score on a scale
Interval 0.3 to 1.0
|
|
Opioid Related Symptom Distress Scale (ORSDS)
POD3 ORSDS Composite Score
|
0.3 score on a scale
Interval 0.0 to 0.4
|
0.3 score on a scale
Interval 0.2 to 0.5
|
0.6 score on a scale
Interval 0.3 to 0.9
|
|
Opioid Related Symptom Distress Scale (ORSDS)
POD4 ORSDS Composite Score
|
0.2 score on a scale
Interval 0.1 to 0.4
|
0.3 score on a scale
Interval 0.1 to 0.6
|
0.4 score on a scale
Interval 0.2 to 0.9
|
|
Opioid Related Symptom Distress Scale (ORSDS)
POD7 ORSDS Composite Score
|
0.3 score on a scale
Interval 0.1 to 0.4
|
0.2 score on a scale
Interval 0.2 to 0.4
|
0.6 score on a scale
Interval 0.3 to 0.8
|
|
Opioid Related Symptom Distress Scale (ORSDS)
3 Month ORSDS Composite Score
|
0.1 score on a scale
Interval 0.0 to 0.2
|
0.0 score on a scale
Interval 0.0 to 0.1
|
0.0 score on a scale
Interval 0.0 to 0.3
|
|
Opioid Related Symptom Distress Scale (ORSDS)
POD1 ORSDS Nausea Score
|
0.0 score on a scale
Interval 0.0 to 0.7
|
0.0 score on a scale
Interval 0.0 to 1.5
|
0.6 score on a scale
Interval 0.0 to 2.4
|
|
Opioid Related Symptom Distress Scale (ORSDS)
POD2 ORSDS Nausea Score
|
0.0 score on a scale
Interval 0.0 to 0.9
|
0.5 score on a scale
Interval 0.0 to 1.7
|
1.2 score on a scale
Interval 0.0 to 1.9
|
|
Opioid Related Symptom Distress Scale (ORSDS)
POD3 ORSDS Nausea Score
|
0.0 score on a scale
Interval 0.0 to 0.0
|
0.0 score on a scale
Interval 0.0 to 0.6
|
0.0 score on a scale
Interval 0.0 to 1.5
|
|
Opioid Related Symptom Distress Scale (ORSDS)
POD4 ORSDS Nausea Score
|
0.0 score on a scale
Interval 0.0 to 0.0
|
0.0 score on a scale
Interval 0.0 to 1.3
|
0.0 score on a scale
Interval 0.0 to 0.0
|
|
Opioid Related Symptom Distress Scale (ORSDS)
POD7 ORSDS Nausea Score
|
0.0 score on a scale
Interval 0.0 to 0.0
|
0.0 score on a scale
Interval 0.0 to 0.0
|
0.0 score on a scale
Interval 0.0 to 0.0
|
|
Opioid Related Symptom Distress Scale (ORSDS)
3 Month ORSDS Nausea Score
|
0.0 score on a scale
Interval 0.0 to 0.0
|
0.0 score on a scale
Interval 0.0 to 0.0
|
0.0 score on a scale
Interval 0.0 to 0.0
|
|
Opioid Related Symptom Distress Scale (ORSDS)
POD1 ORSDS Vomiting Score
|
0.0 score on a scale
Interval 0.0 to 0.0
|
0.0 score on a scale
Interval 0.0 to 0.0
|
0.0 score on a scale
Interval 0.0 to 0.9
|
|
Opioid Related Symptom Distress Scale (ORSDS)
POD2 ORSDS Vomiting Score
|
0.0 score on a scale
Interval 0.0 to 0.0
|
0.0 score on a scale
Interval 0.0 to 0.0
|
0.0 score on a scale
Interval 0.0 to 0.0
|
|
Opioid Related Symptom Distress Scale (ORSDS)
POD3 ORSDS Vomiting Score
|
0.0 score on a scale
Interval 0.0 to 0.0
|
0.0 score on a scale
Interval 0.0 to 0.0
|
0.0 score on a scale
Interval 0.0 to 0.0
|
|
Opioid Related Symptom Distress Scale (ORSDS)
POD4 ORSDS Vomiting Score
|
0.0 score on a scale
Interval 0.0 to 0.0
|
0.0 score on a scale
Interval 0.0 to 0.0
|
0.0 score on a scale
Interval 0.0 to 0.0
|
|
Opioid Related Symptom Distress Scale (ORSDS)
POD7 ORSDS Vomiting Score
|
0.0 score on a scale
Interval 0.0 to 0.0
|
0.0 score on a scale
Interval 0.0 to 0.0
|
0.0 score on a scale
Interval 0.0 to 0.0
|
|
Opioid Related Symptom Distress Scale (ORSDS)
3 Month ORSDS Vomiting Score
|
0.0 score on a scale
Interval 0.0 to 0.0
|
0.0 score on a scale
Interval 0.0 to 0.0
|
0.0 score on a scale
Interval 0.0 to 0.0
|
|
Opioid Related Symptom Distress Scale (ORSDS)
POD1 ORSDS Constipation Score
|
0.0 score on a scale
Interval 0.0 to 0.0
|
0.0 score on a scale
Interval 0.0 to 0.5
|
0.0 score on a scale
Interval 0.0 to 1.3
|
|
Opioid Related Symptom Distress Scale (ORSDS)
POD2 ORSDS Constipation Score
|
0.0 score on a scale
Interval 0.0 to 2.0
|
0.0 score on a scale
Interval 0.0 to 1.8
|
0.0 score on a scale
Interval 0.0 to 2.1
|
|
Opioid Related Symptom Distress Scale (ORSDS)
POD3 ORSDS Constipation Score
|
0.0 score on a scale
Interval 0.0 to 1.2
|
0.0 score on a scale
Interval 0.0 to 0.0
|
0.0 score on a scale
Interval 0.0 to 2.1
|
|
Opioid Related Symptom Distress Scale (ORSDS)
POD4 ORSDS Constipation Score
|
0.0 score on a scale
Interval 0.0 to 1.8
|
0.0 score on a scale
Interval 0.0 to 0.8
|
1.2 score on a scale
Interval 0.0 to 2.2
|
|
Opioid Related Symptom Distress Scale (ORSDS)
POD7 ORSDS Constipation Score
|
0.0 score on a scale
Interval 0.0 to 2.1
|
0.0 score on a scale
Interval 0.0 to 0.0
|
0.0 score on a scale
Interval 0.0 to 2.1
|
|
Opioid Related Symptom Distress Scale (ORSDS)
3 Month ORSDS Constipation Score
|
0.0 score on a scale
Interval 0.0 to 0.0
|
0.0 score on a scale
Interval 0.0 to 0.0
|
0.0 score on a scale
Interval 0.0 to 0.0
|
|
Opioid Related Symptom Distress Scale (ORSDS)
POD1 ORSDS Difficulty Passing Urine Score
|
0.0 score on a scale
Interval 0.0 to 2.0
|
0.0 score on a scale
Interval 0.0 to 0.0
|
0.0 score on a scale
Interval 0.0 to 0.0
|
|
Opioid Related Symptom Distress Scale (ORSDS)
POD2 ORSDS Difficulty Passing Urine Score
|
0.0 score on a scale
Interval 0.0 to 0.0
|
0.0 score on a scale
Interval 0.0 to 0.0
|
0.0 score on a scale
Interval 0.0 to 0.0
|
|
Opioid Related Symptom Distress Scale (ORSDS)
POD3 ORSDS Difficulty Passing Urine Score
|
0.0 score on a scale
Interval 0.0 to 0.0
|
0.0 score on a scale
Interval 0.0 to 0.0
|
0.0 score on a scale
Interval 0.0 to 0.0
|
|
Opioid Related Symptom Distress Scale (ORSDS)
POD4 ORSDS Difficulty Passing Urine Score
|
0.0 score on a scale
Interval 0.0 to 0.0
|
0.0 score on a scale
Interval 0.0 to 0.0
|
0.0 score on a scale
Interval 0.0 to 0.0
|
|
Opioid Related Symptom Distress Scale (ORSDS)
POD7 ORSDS Difficulty Passing Urine Score
|
0.0 score on a scale
Interval 0.0 to 0.0
|
0.0 score on a scale
Interval 0.0 to 0.0
|
0.0 score on a scale
Interval 0.0 to 0.0
|
|
Opioid Related Symptom Distress Scale (ORSDS)
3 Month ORSDS Difficulty Passing Urine Score
|
0.0 score on a scale
Interval 0.0 to 0.0
|
0.0 score on a scale
Interval 0.0 to 0.0
|
0.0 score on a scale
Interval 0.0 to 0.0
|
|
Opioid Related Symptom Distress Scale (ORSDS)
POD1 ORSDS Difficulty Concentrating Score
|
0.0 score on a scale
Interval 0.0 to 0.6
|
0.0 score on a scale
Interval 0.0 to 0.0
|
0.0 score on a scale
Interval 0.0 to 1.7
|
|
Opioid Related Symptom Distress Scale (ORSDS)
POD2 ORSDS Difficulty Concentrating Score
|
0.0 score on a scale
Interval 0.0 to 1.5
|
0.0 score on a scale
Interval 0.0 to 0.0
|
0.0 score on a scale
Interval 0.0 to 0.9
|
|
Opioid Related Symptom Distress Scale (ORSDS)
POD3 ORSDS Difficulty Concentrating Score
|
0.0 score on a scale
Interval 0.0 to 0.0
|
0.0 score on a scale
Interval 0.0 to 0.0
|
0.0 score on a scale
Interval 0.0 to 0.0
|
|
Opioid Related Symptom Distress Scale (ORSDS)
POD4 ORSDS Difficulty Concentrating Score
|
0.0 score on a scale
Interval 0.0 to 0.0
|
0.0 score on a scale
Interval 0.0 to 0.0
|
0.0 score on a scale
Interval 0.0 to 0.0
|
|
Opioid Related Symptom Distress Scale (ORSDS)
POD7 ORSDS Difficulty Concentrating Score
|
0.0 score on a scale
Interval 0.0 to 1.2
|
0.0 score on a scale
Interval 0.0 to 0.0
|
0.0 score on a scale
Interval 0.0 to 1.2
|
|
Opioid Related Symptom Distress Scale (ORSDS)
3 Month ORSDS Difficulty Concentrating Score
|
0.0 score on a scale
Interval 0.0 to 0.0
|
0.0 score on a scale
Interval 0.0 to 0.0
|
0.0 score on a scale
Interval 0.0 to 0.0
|
|
Opioid Related Symptom Distress Scale (ORSDS)
POD1 ORSDS Drowsiness Score
|
0.0 score on a scale
Interval 0.0 to 1.3
|
0.0 score on a scale
Interval 0.0 to 0.6
|
1.8 score on a scale
Interval 0.0 to 2.6
|
|
Opioid Related Symptom Distress Scale (ORSDS)
POD2 ORSDS Drowsiness Score
|
1.1 score on a scale
Interval 0.0 to 1.7
|
0.6 score on a scale
Interval 0.0 to 1.5
|
1.5 score on a scale
Interval 0.0 to 2.3
|
|
Opioid Related Symptom Distress Scale (ORSDS)
POD3 ORSDS Drowsiness Score
|
0.0 score on a scale
Interval 0.0 to 1.5
|
0.0 score on a scale
Interval 0.0 to 1.9
|
1.5 score on a scale
Interval 0.0 to 1.9
|
|
Opioid Related Symptom Distress Scale (ORSDS)
POD4 ORSDS Drowsiness Score
|
0.0 score on a scale
Interval 0.0 to 1.2
|
0.0 score on a scale
Interval 0.0 to 1.8
|
0.9 score on a scale
Interval 0.0 to 1.8
|
|
Opioid Related Symptom Distress Scale (ORSDS)
POD7 ORSDS Drowsiness Score
|
1.2 score on a scale
Interval 0.0 to 1.9
|
0.0 score on a scale
Interval 0.0 to 1.6
|
1.5 score on a scale
Interval 0.0 to 2.1
|
|
Opioid Related Symptom Distress Scale (ORSDS)
3 Month ORSDS Drowsiness Score
|
0.0 score on a scale
Interval 0.0 to 0.0
|
0.0 score on a scale
Interval 0.0 to 0.0
|
0.0 score on a scale
Interval 0.0 to 0.0
|
|
Opioid Related Symptom Distress Scale (ORSDS)
POD1 ORSDS Dizziness Score
|
0.6 score on a scale
Interval 0.0 to 1.5
|
0.6 score on a scale
Interval 0.0 to 1.6
|
1.8 score on a scale
Interval 0.0 to 2.6
|
|
Opioid Related Symptom Distress Scale (ORSDS)
POD2 ORSDS Dizziness Score
|
0.0 score on a scale
Interval 0.0 to 0.0
|
0.0 score on a scale
Interval 0.0 to 1.7
|
1.2 score on a scale
Interval 0.0 to 1.8
|
|
Opioid Related Symptom Distress Scale (ORSDS)
POD3 ORSDS Dizziness Score
|
0.0 score on a scale
Interval 0.0 to 1.2
|
0.0 score on a scale
Interval 0.0 to 1.1
|
0.0 score on a scale
Interval 0.0 to 1.5
|
|
Opioid Related Symptom Distress Scale (ORSDS)
POD4 ORSDS Dizziness Score
|
0.0 score on a scale
Interval 0.0 to 0.0
|
0.0 score on a scale
Interval 0.0 to 0.0
|
0.0 score on a scale
Interval 0.0 to 1.2
|
|
Opioid Related Symptom Distress Scale (ORSDS)
POD7 ORSDS Dizziness Score
|
0.0 score on a scale
Interval 0.0 to 0.0
|
0.0 score on a scale
Interval 0.0 to 0.0
|
0.0 score on a scale
Interval 0.0 to 1.2
|
|
Opioid Related Symptom Distress Scale (ORSDS)
3 Month ORSDS Dizziness Score
|
0.0 score on a scale
Interval 0.0 to 0.0
|
0.0 score on a scale
Interval 0.0 to 0.0
|
0.0 score on a scale
Interval 0.0 to 0.0
|
|
Opioid Related Symptom Distress Scale (ORSDS)
POD1 ORSDS Confusion Score
|
0.0 score on a scale
Interval 0.0 to 0.0
|
0.0 score on a scale
Interval 0.0 to 0.0
|
0.0 score on a scale
Interval 0.0 to 1.7
|
|
Opioid Related Symptom Distress Scale (ORSDS)
POD2 ORSDS Confusion Score
|
0.0 score on a scale
Interval 0.0 to 0.0
|
0.0 score on a scale
Interval 0.0 to 0.0
|
0.0 score on a scale
Interval 0.0 to 0.0
|
|
Opioid Related Symptom Distress Scale (ORSDS)
POD3 ORSDS Confusion Score
|
0.0 score on a scale
Interval 0.0 to 0.0
|
0.0 score on a scale
Interval 0.0 to 0.0
|
0.0 score on a scale
Interval 0.0 to 0.0
|
|
Opioid Related Symptom Distress Scale (ORSDS)
POD4 ORSDS Confusion Score
|
0.0 score on a scale
Interval 0.0 to 0.0
|
0.0 score on a scale
Interval 0.0 to 0.0
|
0.0 score on a scale
Interval 0.0 to 0.0
|
|
Opioid Related Symptom Distress Scale (ORSDS)
POD7 ORSDS Confusion Score
|
0.0 score on a scale
Interval 0.0 to 0.0
|
0.0 score on a scale
Interval 0.0 to 0.0
|
0.0 score on a scale
Interval 0.0 to 0.0
|
|
Opioid Related Symptom Distress Scale (ORSDS)
3 Month POD1 ORSDS Confusion Score
|
0.0 score on a scale
Interval 0.0 to 0.0
|
0.0 score on a scale
Interval 0.0 to 0.0
|
0.0 score on a scale
Interval 0.0 to 0.0
|
|
Opioid Related Symptom Distress Scale (ORSDS)
POD1 ORSDS Fatigue Score
|
0.0 score on a scale
Interval 0.0 to 0.0
|
0.6 score on a scale
Interval 0.0 to 1.9
|
1.9 score on a scale
Interval 1.4 to 2.9
|
|
Opioid Related Symptom Distress Scale (ORSDS)
POD2 ORSDS Fatigue Score
|
0.0 score on a scale
Interval 0.0 to 1.1
|
1.6 score on a scale
Interval 0.0 to 1.9
|
1.5 score on a scale
Interval 0.0 to 2.2
|
|
Opioid Related Symptom Distress Scale (ORSDS)
POD3 ORSDS Fatigue Score
|
0.0 score on a scale
Interval 0.0 to 1.9
|
0.0 score on a scale
Interval 0.0 to 1.7
|
1.9 score on a scale
Interval 0.0 to 3.1
|
|
Opioid Related Symptom Distress Scale (ORSDS)
POD4 ORSDS Fatigue Score
|
0.0 score on a scale
Interval 0.0 to 0.0
|
1.8 score on a scale
Interval 0.0 to 2.0
|
1.5 score on a scale
Interval 0.0 to 2.1
|
|
Opioid Related Symptom Distress Scale (ORSDS)
POD7 ORSDS Fatigue Score
|
0.5 score on a scale
Interval 0.0 to 1.5
|
1.8 score on a scale
Interval 0.0 to 1.9
|
1.5 score on a scale
Interval 0.0 to 2.2
|
|
Opioid Related Symptom Distress Scale (ORSDS)
3 Month ORSDS Fatigue Score
|
0.0 score on a scale
Interval 0.0 to 1.5
|
0.0 score on a scale
Interval 0.0 to 1.3
|
0.0 score on a scale
Interval 0.0 to 1.8
|
|
Opioid Related Symptom Distress Scale (ORSDS)
POD1 ORSDS Itchiness Score
|
0.0 score on a scale
Interval 0.0 to 0.0
|
0.0 score on a scale
Interval 0.0 to 0.0
|
0.0 score on a scale
Interval 0.0 to 1.8
|
|
Opioid Related Symptom Distress Scale (ORSDS)
POD2 ORSDS Itchiness Score
|
0.0 score on a scale
Interval 0.0 to 0.0
|
0.0 score on a scale
Interval 0.0 to 1.2
|
0.0 score on a scale
Interval 0.0 to 1.2
|
|
Opioid Related Symptom Distress Scale (ORSDS)
POD3 ORSDS Itchiness Score
|
0.0 score on a scale
Interval 0.0 to 1.2
|
0.0 score on a scale
Interval 0.0 to 0.6
|
0.0 score on a scale
Interval 0.0 to 2.7
|
|
Opioid Related Symptom Distress Scale (ORSDS)
POD4 ORSDS Itchiness Score
|
0.0 score on a scale
Interval 0.0 to 0.9
|
0.0 score on a scale
Interval 0.0 to 0.5
|
0.0 score on a scale
Interval 0.0 to 1.8
|
|
Opioid Related Symptom Distress Scale (ORSDS)
POD7 ORSDS Itchiness Score
|
0.0 score on a scale
Interval 0.0 to 0.0
|
0.0 score on a scale
Interval 0.0 to 1.2
|
0.0 score on a scale
Interval 0.0 to 2.1
|
|
Opioid Related Symptom Distress Scale (ORSDS)
3 Month ORSDS Itchiness Score
|
0.0 score on a scale
Interval 0.0 to 0.0
|
0.0 score on a scale
Interval 0.0 to 0.0
|
0.0 score on a scale
Interval 0.0 to 0.0
|
|
Opioid Related Symptom Distress Scale (ORSDS)
POD1 ORSDS Dry Mouth Score
|
0.6 score on a scale
Interval 0.0 to 2.0
|
0.6 score on a scale
Interval 0.0 to 2.4
|
1.5 score on a scale
Interval 0.0 to 2.7
|
|
Opioid Related Symptom Distress Scale (ORSDS)
POD2 ORSDS Dry Mouth Score
|
0.0 score on a scale
Interval 0.0 to 1.2
|
0.6 score on a scale
Interval 0.0 to 2.2
|
1.7 score on a scale
Interval 0.9 to 2.1
|
|
Opioid Related Symptom Distress Scale (ORSDS)
POD3 ORSDS Dry Mouth Score
|
0.0 score on a scale
Interval 0.0 to 0.9
|
0.5 score on a scale
Interval 0.0 to 2.1
|
0.0 score on a scale
Interval 0.0 to 2.5
|
|
Opioid Related Symptom Distress Scale (ORSDS)
POD4 ORSDS Dry Mouth Score
|
0.0 score on a scale
Interval 0.0 to 0.0
|
0.0 score on a scale
Interval 0.0 to 1.2
|
0.9 score on a scale
Interval 0.0 to 2.1
|
|
Opioid Related Symptom Distress Scale (ORSDS)
POD7 ORSDS Dry Mouth Score
|
0.0 score on a scale
Interval 0.0 to 0.0
|
0.0 score on a scale
Interval 0.0 to 0.0
|
1.5 score on a scale
Interval 0.0 to 2.5
|
|
Opioid Related Symptom Distress Scale (ORSDS)
3 Month ORSDS Dry Mouth Score
|
0.0 score on a scale
Interval 0.0 to 0.0
|
0.0 score on a scale
Interval 0.0 to 0.0
|
0.0 score on a scale
Interval 0.0 to 0.0
|
|
Opioid Related Symptom Distress Scale (ORSDS)
POD1 ORSDS Headache Score
|
0.0 score on a scale
Interval 0.0 to 0.0
|
0.0 score on a scale
Interval 0.0 to 0.0
|
0.0 score on a scale
Interval 0.0 to 0.0
|
|
Opioid Related Symptom Distress Scale (ORSDS)
POD2 ORSDS Headache Score
|
0.0 score on a scale
Interval 0.0 to 0.0
|
0.0 score on a scale
Interval 0.0 to 0.0
|
0.0 score on a scale
Interval 0.0 to 0.0
|
|
Opioid Related Symptom Distress Scale (ORSDS)
POD3 ORSDS Headache Score
|
0.0 score on a scale
Interval 0.0 to 0.0
|
0.0 score on a scale
Interval 0.0 to 0.0
|
0.0 score on a scale
Interval 0.0 to 0.0
|
|
Opioid Related Symptom Distress Scale (ORSDS)
POD4 ORSDS Headache Score
|
0.0 score on a scale
Interval 0.0 to 0.0
|
0.0 score on a scale
Interval 0.0 to 0.0
|
0.0 score on a scale
Interval 0.0 to 1.5
|
|
Opioid Related Symptom Distress Scale (ORSDS)
POD7 ORSDS Headache Score
|
0.0 score on a scale
Interval 0.0 to 0.0
|
0.0 score on a scale
Interval 0.0 to 0.0
|
0.0 score on a scale
Interval 0.0 to 2.7
|
|
Opioid Related Symptom Distress Scale (ORSDS)
3 Month ORSDS Headache Score
|
0.0 score on a scale
Interval 0.0 to 0.0
|
0.0 score on a scale
Interval 0.0 to 0.0
|
0.0 score on a scale
Interval 0.0 to 0.0
|
SECONDARY outcome
Timeframe: Preoperatively; Morning of postoperative day (POD) 1,2,3,4,7 and at 3 monthsPopulation: Reasons for discrepancy between analyzed and overall number analyzed: withdrawn or lost to follow-up, missed data collection One participant in the Ora-sweet SF group was not included in the analysis due to screen failing after enrollment. Therefore, 12 patients in each group were included in the analysis.
Hospital Anxiety and Depression Scale (HADS) asks 14 questions, 7 about anxiety and 7 about depression. Responses are scored from 0-3. Responses between the two categories are summed and scoring is as follows: 0-7 = normal, 8-10=borderlines abnormal, 11-21=abnormal
Outcome measures
| Measure |
Ora-sweet SF
n=12 Participants
Ora-sweet SF: Ora-sweet SF placebo
|
400mg Cannabidiol
n=12 Participants
cannabidiol: Epidiolex (cannabidiol) oral solution
|
800mg Cannabidiol
n=12 Participants
cannabidiol: Epidiolex (cannabidiol) oral solution
|
|---|---|---|---|
|
Anxiety Levels
POD1 HADS Anxiety Score
|
2.5 score on a scale
Interval 1.5 to 4.5
|
3.0 score on a scale
Interval 1.0 to 5.0
|
5.0 score on a scale
Interval 2.0 to 7.5
|
|
Anxiety Levels
3 Month HADS Depression Score
|
0.0 score on a scale
Interval 0.0 to 1.0
|
1.0 score on a scale
Interval 0.0 to 2.0
|
1.0 score on a scale
Interval 0.0 to 2.0
|
|
Anxiety Levels
Preop HADS Anxiety Score
|
3.0 score on a scale
Interval 2.0 to 5.0
|
6.5 score on a scale
Interval 4.0 to 10.0
|
6.0 score on a scale
Interval 1.5 to 9.5
|
|
Anxiety Levels
POD2 HADS Anxiety Score
|
2.0 score on a scale
Interval 1.5 to 4.5
|
4.0 score on a scale
Interval 2.5 to 6.0
|
5.0 score on a scale
Interval 3.0 to 8.0
|
|
Anxiety Levels
POD3 HADS Anxiety Score
|
2.0 score on a scale
Interval 1.0 to 3.0
|
2.5 score on a scale
Interval 1.0 to 5.5
|
3.0 score on a scale
Interval 2.0 to 8.0
|
|
Anxiety Levels
POD4 HADS Anxiety Score
|
2.0 score on a scale
Interval 1.0 to 4.0
|
2.0 score on a scale
Interval 1.0 to 4.5
|
2.0 score on a scale
Interval 1.0 to 5.0
|
|
Anxiety Levels
POD7 HADS Anxiety Score
|
1.0 score on a scale
Interval 0.0 to 3.0
|
2.0 score on a scale
Interval 1.0 to 3.5
|
2.0 score on a scale
Interval 1.0 to 5.0
|
|
Anxiety Levels
3 Month HADS Anxiety Score
|
0.0 score on a scale
Interval 0.0 to 1.0
|
1.0 score on a scale
Interval 0.0 to 3.0
|
0.0 score on a scale
Interval 0.0 to 4.0
|
|
Anxiety Levels
Preop HADS Depression Score
|
2.0 score on a scale
Interval 1.0 to 4.0
|
3.5 score on a scale
Interval 2.0 to 5.0
|
4.5 score on a scale
Interval 2.0 to 6.5
|
|
Anxiety Levels
POD1 HADS Depression Score
|
4.0 score on a scale
Interval 1.5 to 7.0
|
4.5 score on a scale
Interval 2.0 to 6.5
|
4.0 score on a scale
Interval 1.5 to 8.5
|
|
Anxiety Levels
POD2 HADS Depression Score
|
4.0 score on a scale
Interval 1.5 to 7.5
|
3.5 score on a scale
Interval 2.0 to 5.5
|
6.0 score on a scale
Interval 3.0 to 9.0
|
|
Anxiety Levels
POD3 HADS Depression Score
|
3.0 score on a scale
Interval 1.0 to 8.0
|
2.5 score on a scale
Interval 2.0 to 5.5
|
6.0 score on a scale
Interval 3.0 to 9.0
|
|
Anxiety Levels
POD4 HADS Depression Score
|
3.0 score on a scale
Interval 1.0 to 5.0
|
3.0 score on a scale
Interval 2.0 to 5.0
|
6.0 score on a scale
Interval 3.0 to 8.0
|
|
Anxiety Levels
POD7 HADS Depression Score
|
1.0 score on a scale
Interval 1.0 to 3.0
|
3.0 score on a scale
Interval 1.5 to 4.0
|
4.0 score on a scale
Interval 3.0 to 7.0
|
SECONDARY outcome
Timeframe: POD0 - POD3Population: One participant in the Ora-sweet SF group was not included in the analysis due to screen failing after enrollment. Therefore, 12 patients in each group were included in the analysis.
Total non-opioid medication usage
Outcome measures
| Measure |
Ora-sweet SF
n=12 Participants
Ora-sweet SF: Ora-sweet SF placebo
|
400mg Cannabidiol
n=12 Participants
cannabidiol: Epidiolex (cannabidiol) oral solution
|
800mg Cannabidiol
n=12 Participants
cannabidiol: Epidiolex (cannabidiol) oral solution
|
|---|---|---|---|
|
Cumulative Inpatient Analgesic Use (Non-opioid)
Acetaminophen consumption
|
7600 milligrams
Standard Deviation 2000
|
7700 milligrams
Standard Deviation 1200
|
8100 milligrams
Standard Deviation 1600
|
|
Cumulative Inpatient Analgesic Use (Non-opioid)
Ketorolac consumption
|
50.0 milligrams
Standard Deviation 21.5
|
47.5 milligrams
Standard Deviation 5.8
|
51.3 milligrams
Standard Deviation 18.6
|
|
Cumulative Inpatient Analgesic Use (Non-opioid)
Meloxicam consumption
|
13.1 milligrams
Standard Deviation 5.7
|
17.5 milligrams
Standard Deviation 3.7
|
21.9 milligrams
Standard Deviation 8.1
|
SECONDARY outcome
Timeframe: POD0 - POD3Population: One participant in the Ora-sweet SF group was not included in the analysis due to screen failing after enrollment. Therefore, 12 patients in each group were included in the analysis.
Opioid and non-opioid medication use by count (%)
Outcome measures
| Measure |
Ora-sweet SF
n=12 Participants
Ora-sweet SF: Ora-sweet SF placebo
|
400mg Cannabidiol
n=12 Participants
cannabidiol: Epidiolex (cannabidiol) oral solution
|
800mg Cannabidiol
n=12 Participants
cannabidiol: Epidiolex (cannabidiol) oral solution
|
|---|---|---|---|
|
Number of Participants With Opioid and Non-opioid Medication Use
Methocarbamol or tizanidine
|
8 Participants
|
6 Participants
|
7 Participants
|
|
Number of Participants With Opioid and Non-opioid Medication Use
Methocarbamol
|
8 Participants
|
6 Participants
|
7 Participants
|
|
Number of Participants With Opioid and Non-opioid Medication Use
Tizanidine
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Opioid and Non-opioid Medication Use
Gabapentin or pregabalin
|
3 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Opioid and Non-opioid Medication Use
Gabapentin
|
3 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Opioid and Non-opioid Medication Use
Pregabalin
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Opioid and Non-opioid Medication Use
Lidocaine patches
|
5 Participants
|
3 Participants
|
5 Participants
|
|
Number of Participants With Opioid and Non-opioid Medication Use
Intravenous hydromorphone (non-PCA)
|
10 Participants
|
4 Participants
|
11 Participants
|
|
Number of Participants With Opioid and Non-opioid Medication Use
Subcutaneous hydromorphone
|
2 Participants
|
1 Participants
|
2 Participants
|
|
Number of Participants With Opioid and Non-opioid Medication Use
IVPCA hydromorphone
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Opioid and Non-opioid Medication Use
Either IV hydromorphone (non-PCA), Subcutaneous hydromorphone, or IVPCA hydromorphone
|
10 Participants
|
4 Participants
|
11 Participants
|
SECONDARY outcome
Timeframe: At hospital discharge to POD7Population: Reasons for discrepancy between analyzed and overall number analyzed: withdrawn or lost to follow-up One participant in the Ora-sweet SF group was not included in the analysis due to screen failing after enrollment. Therefore, 12 patients in each group were included in the analysis.
Total opioid (morphine milligram equivalents) \& non-opioid medication usage
Outcome measures
| Measure |
Ora-sweet SF
n=12 Participants
Ora-sweet SF: Ora-sweet SF placebo
|
400mg Cannabidiol
n=12 Participants
cannabidiol: Epidiolex (cannabidiol) oral solution
|
800mg Cannabidiol
n=12 Participants
cannabidiol: Epidiolex (cannabidiol) oral solution
|
|---|---|---|---|
|
Opioid & Non-opioid Analgesic Consumption
Opioid consumption
|
364.8 milligrams
Standard Deviation 165.6
|
282.3 milligrams
Standard Deviation 167.4
|
360.4 milligrams
Standard Deviation 220.1
|
|
Opioid & Non-opioid Analgesic Consumption
Acetaminophen consumption
|
14100 milligrams
Standard Deviation 4600
|
15300 milligrams
Standard Deviation 5400
|
16000 milligrams
Standard Deviation 6200
|
|
Opioid & Non-opioid Analgesic Consumption
Ketorolac consumption
|
51.0 milligrams
Standard Deviation 23.7
|
47.5 milligrams
Standard Deviation 5.8
|
52.5 milligrams
Standard Deviation 20.3
|
|
Opioid & Non-opioid Analgesic Consumption
Meloxicam consumption
|
42.0 milligrams
Standard Deviation 22.4
|
46.3 milligrams
Standard Deviation 4.3
|
57.8 milligrams
Standard Deviation 22.9
|
SECONDARY outcome
Timeframe: POD0 to POD7 and 3 monthsPopulation: Reasons for discrepancy between analyzed and overall number analyzed: withdrawn or lost to follow-up One participant in the Ora-sweet SF group was not included in the analysis due to screen failing after enrollment. Therefore, 12 patients in each group were included in the analysis.
Opioid \& non-opioid medication use by count (%)
Outcome measures
| Measure |
Ora-sweet SF
n=12 Participants
Ora-sweet SF: Ora-sweet SF placebo
|
400mg Cannabidiol
n=12 Participants
cannabidiol: Epidiolex (cannabidiol) oral solution
|
800mg Cannabidiol
n=12 Participants
cannabidiol: Epidiolex (cannabidiol) oral solution
|
|---|---|---|---|
|
Number of Participants With Opioid and Non-opioid Medication Use
POD0-POD7 Methocarbamol or tizanidine
|
8 Participants
|
8 Participants
|
7 Participants
|
|
Number of Participants With Opioid and Non-opioid Medication Use
POD0-POD7 Methocarbamol
|
8 Participants
|
7 Participants
|
7 Participants
|
|
Number of Participants With Opioid and Non-opioid Medication Use
POD0-POD7 Tizanidine
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Opioid and Non-opioid Medication Use
POD0-POD7 Gabapentin or pregabalin
|
3 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Opioid and Non-opioid Medication Use
POD0-POD7 Gabapentin
|
3 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Opioid and Non-opioid Medication Use
POD0-POD7 Pregabalin
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Opioid and Non-opioid Medication Use
POD0-POD7 Lidocaine patches
|
5 Participants
|
4 Participants
|
5 Participants
|
|
Number of Participants With Opioid and Non-opioid Medication Use
POD0-POD7 Intravenous hydromorphone (non-PCA)
|
10 Participants
|
4 Participants
|
11 Participants
|
|
Number of Participants With Opioid and Non-opioid Medication Use
POD0-POD7 Subcutaneous hydromorphone
|
2 Participants
|
1 Participants
|
2 Participants
|
|
Number of Participants With Opioid and Non-opioid Medication Use
POD0-POD7 IVPCA hydromorphone
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Opioid and Non-opioid Medication Use
POD0-POD7 Either IV hydromorphone (non-PCA), Subcutaneous hydromorphone, or IVPCA hydromorphone
|
10 Participants
|
4 Participants
|
11 Participants
|
|
Number of Participants With Opioid and Non-opioid Medication Use
3 Month Opioid use
|
1 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Opioid and Non-opioid Medication Use
3 Month Acetaminophen use
|
5 Participants
|
5 Participants
|
4 Participants
|
|
Number of Participants With Opioid and Non-opioid Medication Use
3 Month Meloxicam use
|
3 Participants
|
4 Participants
|
3 Participants
|
|
Number of Participants With Opioid and Non-opioid Medication Use
3 Month Methocarbamol or tizanidine use
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Opioid and Non-opioid Medication Use
3 Month Methocarbamol use
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Opioid and Non-opioid Medication Use
3 Month Tizanidine use
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Opioid and Non-opioid Medication Use
3 Month Gabapentin or pregabalin use
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Opioid and Non-opioid Medication Use
3 Month Gabapentin use
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Opioid and Non-opioid Medication Use
3 Month Pregabalin use
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Opioid and Non-opioid Medication Use
3 Month Lidocaine patches use
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: At hospital dischargePopulation: One participant in the Ora-sweet SF group was not included in the analysis due to screen failing after enrollment. Therefore, 12 patients in each group were included in the analysis.
Length of stay measured in hours from end of surgery to hospital discharge
Outcome measures
| Measure |
Ora-sweet SF
n=12 Participants
Ora-sweet SF: Ora-sweet SF placebo
|
400mg Cannabidiol
n=12 Participants
cannabidiol: Epidiolex (cannabidiol) oral solution
|
800mg Cannabidiol
n=12 Participants
cannabidiol: Epidiolex (cannabidiol) oral solution
|
|---|---|---|---|
|
Hospital Length of Stay
|
66.4 hours
Interval 60.0 to 92.8
|
81.3 hours
Interval 44.3 to 128.4
|
81.5 hours
Interval 69.0 to 101.8
|
SECONDARY outcome
Timeframe: POD4Population: One participant in the Ora-sweet SF group was not included in the analysis due to screen failing after enrollment. Therefore, 12 patients in each group were included in the analysis.
Patients are asked which treatment they think they received. The correctness of their guesses is then measured using the bang-blinding index to see if patients were able to accurately guess which treatment they received. It is measured on a scale of -1 to 1. Scores closer to 0 indicate better blinding, or patients not being able to guess their treatment. The index (number) is calculated as a group-level summary statistic, computed from the distribution of guesses across all participants in a group.
Outcome measures
| Measure |
Ora-sweet SF
n=12 Participants
Ora-sweet SF: Ora-sweet SF placebo
|
400mg Cannabidiol
n=12 Participants
cannabidiol: Epidiolex (cannabidiol) oral solution
|
800mg Cannabidiol
n=12 Participants
cannabidiol: Epidiolex (cannabidiol) oral solution
|
|---|---|---|---|
|
Blinding Assessment
Bang Blinding Index - Patients
|
0.17 score on a scale
Interval -0.22 to 0.56
|
0.00 score on a scale
Interval -0.46 to 0.46
|
0.17 score on a scale
Interval -0.29 to 0.61
|
|
Blinding Assessment
Bang Blinding Index - Outcomes Assessor
|
-0.33 score on a scale
Interval -0.87 to 0.2
|
0.67 score on a scale
Interval 0.24 to 1.09
|
0.83 score on a scale
Interval 0.52 to 1.15
|
SECONDARY outcome
Timeframe: At hospital dischargePopulation: Reasons for discrepancy between analyzed and overall number analyzed: study physical therapy goals not completed prior to discharge One participant in the Ora-sweet SF group was not included in the analysis due to screen failing after enrollment. Therefore, 12 patients in each group were included in the analysis.
Physical therapy goals for total knee replacement include walking 100 feet, going up and down 4 stairs, and independent transfer (meaning they can move from a lying to standing position independently). Patients need to complete these goals before being discharged
Outcome measures
| Measure |
Ora-sweet SF
n=12 Participants
Ora-sweet SF: Ora-sweet SF placebo
|
400mg Cannabidiol
n=12 Participants
cannabidiol: Epidiolex (cannabidiol) oral solution
|
800mg Cannabidiol
n=12 Participants
cannabidiol: Epidiolex (cannabidiol) oral solution
|
|---|---|---|---|
|
Time to Reach Discharge Physical Therapy Goals
Independent Transfers
|
45.1 hours
Interval 41.9 to 85.6
|
55.5 hours
Interval 38.5 to 99.7
|
66.8 hours
Interval 64.2 to 79.2
|
|
Time to Reach Discharge Physical Therapy Goals
Ambulation 100 feet
|
39.5 hours
Interval 37.7 to 44.8
|
40.7 hours
Interval 38.5 to 70.2
|
45.4 hours
Interval 44.5 to 66.2
|
|
Time to Reach Discharge Physical Therapy Goals
4-Step Stairs
|
37.3 hours
Interval 18.7 to 41.9
|
47.9 hours
Interval 42.6 to 62.7
|
46.0 hours
Interval 44.4 to 64.5
|
SECONDARY outcome
Timeframe: preoperatively, 6 weeks postoperatively.Population: Reasons for discrepancy between analyzed and overall number analyzed: range of motion data not found One participant in the Ora-sweet SF group was not included in the analysis due to screen failing after enrollment. Therefore, 12 patients in each group were included in the analysis.
Range of motion, or extension and flexion of the knees, are measured preoperatively and at the patients' 6 week surgeon visit. It is measured in degrees
Outcome measures
| Measure |
Ora-sweet SF
n=12 Participants
Ora-sweet SF: Ora-sweet SF placebo
|
400mg Cannabidiol
n=12 Participants
cannabidiol: Epidiolex (cannabidiol) oral solution
|
800mg Cannabidiol
n=12 Participants
cannabidiol: Epidiolex (cannabidiol) oral solution
|
|---|---|---|---|
|
Range of Motion
Postoperative Range of Motion - Right Knee Extension
|
1.0 degrees
Interval 0.0 to 4.0
|
0.0 degrees
Interval 0.0 to 0.0
|
0.0 degrees
Interval 0.0 to 0.0
|
|
Range of Motion
Postoperative Range of Motion - Left Knee Extension
|
0.0 degrees
Interval 0.0 to 1.0
|
0.0 degrees
Interval 0.0 to 0.0
|
0.0 degrees
Interval 0.0 to 0.0
|
|
Range of Motion
Preoperative Range of Motion - Right Knee Flexion
|
120.0 degrees
Interval 102.5 to 125.0
|
110.0 degrees
Interval 107.5 to 117.5
|
106.5 degrees
Interval 100.0 to 110.0
|
|
Range of Motion
Preoperative Range of Motion - Right Knee Extension
|
0.0 degrees
Interval 0.0 to 5.0
|
0.0 degrees
Interval 0.0 to 3.5
|
0.0 degrees
Interval 0.0 to 2.5
|
|
Range of Motion
Preoperative Range of Motion - Left Knee Flexion
|
115.0 degrees
Interval 100.0 to 120.0
|
110.0 degrees
Interval 100.0 to 117.5
|
110.0 degrees
Interval 100.0 to 111.0
|
|
Range of Motion
Preoperative Range of Motion - Left Knee Extension
|
0.0 degrees
Interval 0.0 to 5.0
|
0.0 degrees
Interval 0.0 to 5.0
|
0.0 degrees
Interval 0.0 to 2.5
|
|
Range of Motion
Postoperative Range of Motion - Right Knee Flexion
|
110.0 degrees
Interval 95.0 to 117.5
|
110.0 degrees
Interval 90.0 to 115.0
|
118.5 degrees
Interval 110.0 to 120.0
|
|
Range of Motion
Postoperative Range of Motion - Left Knee Flexion
|
112.5 degrees
Interval 100.0 to 120.0
|
110.0 degrees
Interval 90.0 to 115.0
|
116.5 degrees
Interval 110.0 to 120.0
|
SECONDARY outcome
Timeframe: POD0 - POD3Population: Reasons for discrepancy between analyzed and overall number analyzed: patients discharged and activity monitors returned prior to data collection One participant in the Ora-sweet SF group was not included in the analysis due to screen failing after enrollment. Therefore, 12 patients in each group were included in the analysis.
Sleep quality assessed by actigraphy using ActiGraph wGT3X-BT activity monitor. Higher sleep efficiency indicates better sleep quality. Sleep efficiency was calculated between the hours of 11pm and 6am each night.
Outcome measures
| Measure |
Ora-sweet SF
n=12 Participants
Ora-sweet SF: Ora-sweet SF placebo
|
400mg Cannabidiol
n=12 Participants
cannabidiol: Epidiolex (cannabidiol) oral solution
|
800mg Cannabidiol
n=12 Participants
cannabidiol: Epidiolex (cannabidiol) oral solution
|
|---|---|---|---|
|
Actigraphy Sleep Efficiency
POD0-1 Actigraphy Sleep Efficiency
|
64.8 percent
Interval 48.9 to 81.8
|
59.2 percent
Interval 41.0 to 81.8
|
64.9 percent
Interval 59.2 to 74.2
|
|
Actigraphy Sleep Efficiency
POD1-2 Actigraphy Sleep Efficiency
|
72.2 percent
Interval 60.0 to 84.8
|
66.1 percent
Interval 55.7 to 72.4
|
81.0 percent
Interval 67.5 to 84.6
|
|
Actigraphy Sleep Efficiency
POD2-3 Actigraphy Sleep Efficiency
|
62.7 percent
Interval 55.6 to 77.2
|
74.1 percent
Interval 48.5 to 85.6
|
71.9 percent
Interval 66.2 to 81.7
|
SECONDARY outcome
Timeframe: POD0 - POD3Population: Reasons for discrepancy between analyzed and overall number analyzed: patients discharged and activity monitors returned prior to data collection One participant in the Ora-sweet SF group was not included in the analysis due to screen failing after enrollment. Therefore, 12 patients in each group were included in the analysis.
Sleep quality assessed by actigraphy using ActiGraph wGT3X-BT activity monitor. Higher sleep time indicates better sleep quality. Total sleep time was calculated between the hours of 11pm and 6am each night.
Outcome measures
| Measure |
Ora-sweet SF
n=12 Participants
Ora-sweet SF: Ora-sweet SF placebo
|
400mg Cannabidiol
n=12 Participants
cannabidiol: Epidiolex (cannabidiol) oral solution
|
800mg Cannabidiol
n=12 Participants
cannabidiol: Epidiolex (cannabidiol) oral solution
|
|---|---|---|---|
|
Actigraphy Sleep Time
POD0-1 Actigraphy Sleep Time
|
272.0 minutes
Interval 205.5 to 343.5
|
248.5 minutes
Interval 172.0 to 343.5
|
272.5 minutes
Interval 248.5 to 311.5
|
|
Actigraphy Sleep Time
POD1-2 Actigraphy Sleep Time
|
303.0 minutes
Interval 252.0 to 356.0
|
277.5 minutes
Interval 234.0 to 304.0
|
340.0 minutes
Interval 283.5 to 355.0
|
|
Actigraphy Sleep Time
POD2-3 Actigraphy Sleep Time
|
263.0 minutes
Interval 233.5 to 324.0
|
311.0 minutes
Interval 203.5 to 359.5
|
302.0 minutes
Interval 278.0 to 343.0
|
SECONDARY outcome
Timeframe: preoperatively; morning of postoperative day (POD) 1,2,3,4,7 and at 3 monthsPopulation: Reasons for discrepancy between analyzed and overall number analyzed: withdrawn or lost to follow-up, missed data collection One participant in the Ora-sweet SF group was not included in the analysis due to screen failing after enrollment. Therefore, 12 patients in each group were included in the analysis.
Sleep quality assessed by Leeds sleep evaluation questionnaire (LSEQ). Responses to 10 questions will be measured on a slider scale ranging from 0-100. Higher scores indicate better outcomes. Getting to Sleep domain scores were calculated by averaging the responses to Questions 1-3 regarding falling asleep. Quality of Sleep domain scores were calculated by averaging the responses to Questions 4-5 regarding quality of sleep. Awake Following Sleep domain scores were calculated by averaging the responses to Questions 6-7 regarding awakening from sleep. Behaviour Following Wakening domain scores were calculated by averaging the responses to Questions 8-10 regarding feeling, balance, and coordination upon awakening.
Outcome measures
| Measure |
Ora-sweet SF
n=12 Participants
Ora-sweet SF: Ora-sweet SF placebo
|
400mg Cannabidiol
n=12 Participants
cannabidiol: Epidiolex (cannabidiol) oral solution
|
800mg Cannabidiol
n=12 Participants
cannabidiol: Epidiolex (cannabidiol) oral solution
|
|---|---|---|---|
|
Sleep Quality
Preop LSEQ Getting To Sleep Domain Score
|
13.9 score on a scale
Interval 9.5 to 17.5
|
15.2 score on a scale
Interval 12.5 to 20.5
|
13.4 score on a scale
Interval 11.2 to 16.2
|
|
Sleep Quality
POD1 LSEQ Getting To Sleep Domain Score
|
8.8 score on a scale
Interval 7.1 to 17.9
|
10.2 score on a scale
Interval 6.6 to 17.8
|
10.6 score on a scale
Interval 4.3 to 16.9
|
|
Sleep Quality
POD2 LSEQ Getting To Sleep Domain Score
|
14.7 score on a scale
Interval 7.6 to 21.4
|
20.7 score on a scale
Interval 13.2 to 24.7
|
25.1 score on a scale
Interval 17.5 to 26.6
|
|
Sleep Quality
POD3 LSEQ Getting To Sleep Domain Score
|
22.5 score on a scale
Interval 16.0 to 25.0
|
23.9 score on a scale
Interval 13.5 to 27.0
|
18.0 score on a scale
Interval 8.7 to 25.0
|
|
Sleep Quality
POD4 LSEQ Getting To Sleep Domain Score
|
19.6 score on a scale
Interval 15.0 to 23.0
|
20.3 score on a scale
Interval 15.0 to 23.0
|
21.0 score on a scale
Interval 16.4 to 27.0
|
|
Sleep Quality
POD7 LSEQ Getting To Sleep Domain Score
|
15.0 score on a scale
Interval 13.0 to 24.0
|
16.5 score on a scale
Interval 8.6 to 24.0
|
13.0 score on a scale
Interval 12.0 to 24.0
|
|
Sleep Quality
3 Month LSEQ Getting To Sleep Domain Score
|
18.0 score on a scale
Interval 15.0 to 24.0
|
23.0 score on a scale
Interval 15.0 to 28.5
|
15.0 score on a scale
Interval 13.5 to 22.5
|
|
Sleep Quality
Preop LSEQ Quality Of Sleep Domain Score
|
6.1 score on a scale
Interval 1.9 to 9.8
|
9.3 score on a scale
Interval 4.6 to 10.0
|
7.2 score on a scale
Interval 5.1 to 9.2
|
|
Sleep Quality
POD1 LSEQ Quality Of Sleep Domain Score
|
9.0 score on a scale
Interval 1.3 to 11.5
|
3.5 score on a scale
Interval 1.9 to 12.6
|
2.1 score on a scale
Interval 0.6 to 3.6
|
|
Sleep Quality
POD2 LSEQ Quality Of Sleep Domain Score
|
9.5 score on a scale
Interval 1.9 to 11.1
|
10.0 score on a scale
Interval 4.8 to 14.4
|
9.6 score on a scale
Interval 6.9 to 18.0
|
|
Sleep Quality
POD3 LSEQ Quality Of Sleep Domain Score
|
8.4 score on a scale
Interval 3.8 to 16.0
|
11.2 score on a scale
Interval 6.2 to 17.6
|
10.0 score on a scale
Interval 2.6 to 14.0
|
|
Sleep Quality
POD4 LSEQ Quality Of Sleep Domain Score
|
8.8 score on a scale
Interval 6.0 to 12.0
|
10.9 score on a scale
Interval 9.0 to 15.4
|
14.0 score on a scale
Interval 10.0 to 18.0
|
|
Sleep Quality
POD7 LSEQ Quality Of Sleep Domain Score
|
6.0 score on a scale
Interval 2.0 to 11.0
|
9.5 score on a scale
Interval 6.5 to 15.0
|
8.0 score on a scale
Interval 6.0 to 16.0
|
|
Sleep Quality
3 Month LSEQ Quality Of Sleep Domain Score
|
9.5 score on a scale
Interval 5.0 to 10.0
|
13.0 score on a scale
Interval 10.0 to 18.0
|
10.0 score on a scale
Interval 6.0 to 10.0
|
|
Sleep Quality
Preop LSEQ Awake Following Sleep Domain Score
|
9.5 score on a scale
Interval 5.3 to 11.0
|
12.0 score on a scale
Interval 9.2 to 17.9
|
9.2 score on a scale
Interval 8.8 to 10.4
|
|
Sleep Quality
POD1 LSEQ Awake Following Sleep Domain Score
|
10.0 score on a scale
Interval 8.8 to 14.8
|
10.8 score on a scale
Interval 9.8 to 16.3
|
9.7 score on a scale
Interval 3.3 to 15.1
|
|
Sleep Quality
POD2 LSEQ Awake Following Sleep Domain Score
|
11.6 score on a scale
Interval 10.0 to 12.5
|
10.8 score on a scale
Interval 10.0 to 15.3
|
13.1 score on a scale
Interval 9.6 to 17.5
|
|
Sleep Quality
POD3 LSEQ Awake Following Sleep Domain Score
|
10.0 score on a scale
Interval 8.4 to 16.0
|
12.8 score on a scale
Interval 9.7 to 17.6
|
10.0 score on a scale
Interval 7.8 to 12.6
|
|
Sleep Quality
POD4 LSEQ Awake Following Sleep Domain Score
|
10.0 score on a scale
Interval 10.0 to 16.0
|
14.7 score on a scale
Interval 11.0 to 17.3
|
14.0 score on a scale
Interval 9.5 to 18.0
|
|
Sleep Quality
POD7 LSEQ Awake Following Sleep Domain Score
|
10.0 score on a scale
Interval 10.0 to 16.0
|
10.0 score on a scale
Interval 8.5 to 13.0
|
16.0 score on a scale
Interval 10.0 to 18.0
|
|
Sleep Quality
3 Month LSEQ Awake Following Sleep Domain Score
|
14.0 score on a scale
Interval 10.0 to 20.0
|
18.0 score on a scale
Interval 12.0 to 19.0
|
10.0 score on a scale
Interval 10.0 to 15.0
|
|
Sleep Quality
Preop LSEQ Behaviour Following Wakening Domain Score
|
15.9 score on a scale
Interval 11.1 to 22.7
|
16.9 score on a scale
Interval 10.1 to 20.2
|
12.6 score on a scale
Interval 9.6 to 17.5
|
|
Sleep Quality
POD1 LSEQ Behaviour Following Wakening Domain Score
|
15.7 score on a scale
Interval 12.1 to 21.4
|
14.3 score on a scale
Interval 6.7 to 20.1
|
7.9 score on a scale
Interval 3.0 to 12.0
|
|
Sleep Quality
POD2 LSEQ Behaviour Following Wakening Domain Score
|
15.6 score on a scale
Interval 8.7 to 19.9
|
13.6 score on a scale
Interval 7.9 to 17.8
|
14.2 score on a scale
Interval 9.8 to 23.9
|
|
Sleep Quality
POD3 LSEQ Behaviour Following Wakening Domain Score
|
18.0 score on a scale
Interval 13.1 to 21.3
|
16.2 score on a scale
Interval 12.7 to 24.7
|
14.5 score on a scale
Interval 8.1 to 20.4
|
|
Sleep Quality
POD4 LSEQ Behaviour Following Wakening Domain Score
|
20.0 score on a scale
Interval 19.0 to 24.0
|
20.8 score on a scale
Interval 15.0 to 27.0
|
20.0 score on a scale
Interval 12.5 to 24.0
|
|
Sleep Quality
POD7 LSEQ Behaviour Following Wakening Domain Score
|
17.0 score on a scale
Interval 15.0 to 20.5
|
20.3 score on a scale
Interval 17.3 to 25.5
|
16.0 score on a scale
Interval 13.0 to 23.5
|
|
Sleep Quality
3 Month LSEQ Behaviour Following Wakening Domain Score
|
25.8 score on a scale
Interval 24.0 to 28.0
|
26.5 score on a scale
Interval 18.5 to 27.0
|
24.0 score on a scale
Interval 16.5 to 29.0
|
Adverse Events
Ora-sweet SF
Serious events: 1 serious events
Other events: 4 other events
Deaths: 0 deaths
400mg Cannabidiol
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
800mg Cannabidiol
Serious events: 1 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Ora-sweet SF
n=12 participants at risk
Ora-sweet SF: Ora-sweet SF placebo
|
400mg Cannabidiol
n=12 participants at risk
cannabidiol: Epidiolex (cannabidiol) oral solution
|
800mg Cannabidiol
n=12 participants at risk
cannabidiol: Epidiolex (cannabidiol) oral solution
|
|---|---|---|---|
|
Gastrointestinal disorders
Small Bowel Obstruction
|
8.3%
1/12 • Adverse event data were collected via systematic assessment through postoperative day 7 and at 3 months postoperatively.
One participant in the Ora-sweet SF group was not included in the analysis due to screen failing after enrollment. Therefore, 12 patients in each group were included in the analysis.
|
0.00%
0/12 • Adverse event data were collected via systematic assessment through postoperative day 7 and at 3 months postoperatively.
One participant in the Ora-sweet SF group was not included in the analysis due to screen failing after enrollment. Therefore, 12 patients in each group were included in the analysis.
|
0.00%
0/12 • Adverse event data were collected via systematic assessment through postoperative day 7 and at 3 months postoperatively.
One participant in the Ora-sweet SF group was not included in the analysis due to screen failing after enrollment. Therefore, 12 patients in each group were included in the analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Oxygen Desaturation
|
0.00%
0/12 • Adverse event data were collected via systematic assessment through postoperative day 7 and at 3 months postoperatively.
One participant in the Ora-sweet SF group was not included in the analysis due to screen failing after enrollment. Therefore, 12 patients in each group were included in the analysis.
|
0.00%
0/12 • Adverse event data were collected via systematic assessment through postoperative day 7 and at 3 months postoperatively.
One participant in the Ora-sweet SF group was not included in the analysis due to screen failing after enrollment. Therefore, 12 patients in each group were included in the analysis.
|
8.3%
1/12 • Adverse event data were collected via systematic assessment through postoperative day 7 and at 3 months postoperatively.
One participant in the Ora-sweet SF group was not included in the analysis due to screen failing after enrollment. Therefore, 12 patients in each group were included in the analysis.
|
Other adverse events
| Measure |
Ora-sweet SF
n=12 participants at risk
Ora-sweet SF: Ora-sweet SF placebo
|
400mg Cannabidiol
n=12 participants at risk
cannabidiol: Epidiolex (cannabidiol) oral solution
|
800mg Cannabidiol
n=12 participants at risk
cannabidiol: Epidiolex (cannabidiol) oral solution
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Hyponatremia
|
33.3%
4/12 • Adverse event data were collected via systematic assessment through postoperative day 7 and at 3 months postoperatively.
One participant in the Ora-sweet SF group was not included in the analysis due to screen failing after enrollment. Therefore, 12 patients in each group were included in the analysis.
|
25.0%
3/12 • Adverse event data were collected via systematic assessment through postoperative day 7 and at 3 months postoperatively.
One participant in the Ora-sweet SF group was not included in the analysis due to screen failing after enrollment. Therefore, 12 patients in each group were included in the analysis.
|
41.7%
5/12 • Adverse event data were collected via systematic assessment through postoperative day 7 and at 3 months postoperatively.
One participant in the Ora-sweet SF group was not included in the analysis due to screen failing after enrollment. Therefore, 12 patients in each group were included in the analysis.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place