Trial Outcomes & Findings for IV vs. Oral Acetaminophen as a Component of Multimodal Analgesia After Total Hip Arthroplasty (NCT NCT03020966)
NCT ID: NCT03020966
Last Updated: 2021-08-10
Results Overview
Numerical rating scale of pain on a scale of 0-10, with 0 representing the minimum value of no pain and 10, representing the maximum, defined as being pain as bad as imaginable.
COMPLETED
PHASE4
154 participants
24 hours after the operation (post-operative day 1)
2021-08-10
Participant Flow
Participant milestones
| Measure |
Oral Tylenol
Patient group receiving 1000mg of oral acetaminophen and an intravenous placebo
Acetaminophen: Oral acetaminophen, intravenous placebo
|
Intravenous Tylenol
Patient group receiving 1000mg of intravenous acetaminophen and an oral placebo
Acetaminophen: Intravenous acetaminophen, oral placebo
|
|---|---|---|
|
Overall Study
STARTED
|
77
|
77
|
|
Overall Study
COMPLETED
|
75
|
77
|
|
Overall Study
NOT COMPLETED
|
2
|
0
|
Reasons for withdrawal
| Measure |
Oral Tylenol
Patient group receiving 1000mg of oral acetaminophen and an intravenous placebo
Acetaminophen: Oral acetaminophen, intravenous placebo
|
Intravenous Tylenol
Patient group receiving 1000mg of intravenous acetaminophen and an oral placebo
Acetaminophen: Intravenous acetaminophen, oral placebo
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
0
|
Baseline Characteristics
IV vs. Oral Acetaminophen as a Component of Multimodal Analgesia After Total Hip Arthroplasty
Baseline characteristics by cohort
| Measure |
Oral Tylenol
n=77 Participants
Patient group receiving 1000mg of oral acetaminophen and an intravenous placebo
Acetaminophen: Oral acetaminophen, intravenous placebo
|
Intravenous Tylenol
n=77 Participants
Patient group receiving 1000mg of intravenous acetaminophen and an oral placebo
Acetaminophen: Intravenous acetaminophen, oral placebo
|
Total
n=154 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
40 Participants
n=39 Participants
|
39 Participants
n=41 Participants
|
79 Participants
n=35 Participants
|
|
Age, Categorical
>=65 years
|
37 Participants
n=39 Participants
|
38 Participants
n=41 Participants
|
75 Participants
n=35 Participants
|
|
Age, Continuous
|
65 years
STANDARD_DEVIATION 10 • n=39 Participants
|
63 years
STANDARD_DEVIATION 10 • n=41 Participants
|
64 years
STANDARD_DEVIATION 10 • n=35 Participants
|
|
Sex: Female, Male
Female
|
42 Participants
n=39 Participants
|
49 Participants
n=41 Participants
|
91 Participants
n=35 Participants
|
|
Sex: Female, Male
Male
|
35 Participants
n=39 Participants
|
28 Participants
n=41 Participants
|
63 Participants
n=35 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=39 Participants
|
2 Participants
n=41 Participants
|
5 Participants
n=35 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
74 Participants
n=39 Participants
|
75 Participants
n=41 Participants
|
149 Participants
n=35 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=39 Participants
|
3 Participants
n=41 Participants
|
3 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
1 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=39 Participants
|
4 Participants
n=41 Participants
|
8 Participants
n=35 Participants
|
|
Race (NIH/OMB)
White
|
70 Participants
n=39 Participants
|
69 Participants
n=41 Participants
|
139 Participants
n=35 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=39 Participants
|
1 Participants
n=41 Participants
|
3 Participants
n=35 Participants
|
|
Region of Enrollment
United States
|
77 participants
n=39 Participants
|
77 participants
n=41 Participants
|
154 participants
n=35 Participants
|
PRIMARY outcome
Timeframe: 24 hours after the operation (post-operative day 1)Population: Three patients withdrew from the protocol, but were followed using intention-to-treat principles. One patient did not wish to answer the postoperative questions, 1 could not swallow the pills, and 1 received a different anesthetic/analgesic protocol due to pre-existing expectations.
Numerical rating scale of pain on a scale of 0-10, with 0 representing the minimum value of no pain and 10, representing the maximum, defined as being pain as bad as imaginable.
Outcome measures
| Measure |
Oral Tylenol
n=75 Participants
Patient group receiving 1000mg of oral acetaminophen and an intravenous placebo
Acetaminophen: Oral acetaminophen, intravenous placebo
|
Intravenous Tylenol
n=76 Participants
Patient group receiving 1000mg of intravenous acetaminophen and an oral placebo
Acetaminophen: Intravenous acetaminophen, oral placebo
|
|---|---|---|
|
Pain With Physical Therapy on Post-operative Day 1
|
3.6 score on a scale
Standard Deviation 2.4
|
3.9 score on a scale
Standard Deviation 2.4
|
PRIMARY outcome
Timeframe: Day of surgery to post-operative day 3Oral morphine equivalents, cumulative, POD 0-3. Recorded in Medication Usage Database.
Outcome measures
| Measure |
Oral Tylenol
n=65 Participants
Patient group receiving 1000mg of oral acetaminophen and an intravenous placebo
Acetaminophen: Oral acetaminophen, intravenous placebo
|
Intravenous Tylenol
n=61 Participants
Patient group receiving 1000mg of intravenous acetaminophen and an oral placebo
Acetaminophen: Intravenous acetaminophen, oral placebo
|
|---|---|---|
|
Opioid Use
|
108 Oral Morphine Equivalent (mg)
Standard Deviation 63
|
121 Oral Morphine Equivalent (mg)
Standard Deviation 71
|
PRIMARY outcome
Timeframe: 24 hours after surgery (Post-operative day 1)Population: Three patients withdrew from the protocol, but were followed using intention-to-treat principles. One patient did not wish to answer the postoperative questions, 1 could not swallow the pills, and 1 received a different anesthetic/analgesic protocol due to pre-existing expectations. In addition, ORSDS on POD 1 was not recorded for two patients who were lost to follow up.
The Opioid-Related Symptom Distress Scale (ORSDS) is a Likert scale that evaluates 3 symptom distress dimensions (frequency, severity, bothersomeness) for 12 symptoms. Frequency is rated on a 4-point scale (1= 'Rarely', 4= 'Almost constantly'). Severity is rated on a 4-point scale (1= 'Slightly', 4= 'Very'). Bothersomeness is rated on a 5-point scale (0.8= 'Not at all', 4.0= 'Very much'). The symptom-specific ORSDS is the average of the 3 symptom distress dimensions. The composite ORSDS score is the average of 12 symptom-specific scores.
Outcome measures
| Measure |
Oral Tylenol
n=74 Participants
Patient group receiving 1000mg of oral acetaminophen and an intravenous placebo
Acetaminophen: Oral acetaminophen, intravenous placebo
|
Intravenous Tylenol
n=75 Participants
Patient group receiving 1000mg of intravenous acetaminophen and an oral placebo
Acetaminophen: Intravenous acetaminophen, oral placebo
|
|---|---|---|
|
Opioid Side Effects
|
0.4 score on a scale
Standard Deviation 0.3
|
0.3 score on a scale
Standard Deviation 0.3
|
Adverse Events
Oral Tylenol
Intravenous Tylenol
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place