Trial Outcomes & Findings for Determine the Clinical Advantage of IV vs PO Acetaminophen (NCT NCT03558555)
NCT ID: NCT03558555
Last Updated: 2020-02-10
Results Overview
Post-Anesthesia Care Unity (PACU) pain scores at baseline, 1 hour, and on discharge from PACU. Pain score by visual analogue score, total scale from 0 to 10 with 10 being the worse pain.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
103 participants
Primary outcome timeframe
baseline, 1 hour, and Day 1 discharge
Results posted on
2020-02-10
Participant Flow
Participants presenting for laparoscopic hernia repair under general anesthesia in an ambulatory setting were recruited from July 2017 to December 2018. First enrollment in Dec 2017.
Participant milestones
| Measure |
Oral Acetaminophen
Oral acetaminophen 975mg preoperatively and receive intravenous saline intraoperatively.
|
Acetaminophen IV Soln
Acetaminophen 1000mg IV Soln after induction of general anesthesia and placebo pills preoperatively
|
|---|---|---|
|
Overall Study
STARTED
|
58
|
45
|
|
Overall Study
COMPLETED
|
56
|
44
|
|
Overall Study
NOT COMPLETED
|
2
|
1
|
Reasons for withdrawal
| Measure |
Oral Acetaminophen
Oral acetaminophen 975mg preoperatively and receive intravenous saline intraoperatively.
|
Acetaminophen IV Soln
Acetaminophen 1000mg IV Soln after induction of general anesthesia and placebo pills preoperatively
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
2
|
1
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Oral Acetaminophen
n=56 Participants
Oral acetaminophen 975mg preoperatively and receive intravenous saline intraoperatively.
|
Acetaminophen IV Soln
n=44 Participants
Acetaminophen 1000mg IV Soln after induction of general anesthesia and placebo pills preoperatively
|
Total
n=100 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
53.93 years
STANDARD_DEVIATION 13.37 • n=56 Participants
|
52.52 years
STANDARD_DEVIATION 15.10 • n=44 Participants
|
53.31 years
STANDARD_DEVIATION 14.10 • n=100 Participants
|
|
Sex: Female, Male
Female
|
23 Participants
n=56 Participants
|
20 Participants
n=44 Participants
|
43 Participants
n=100 Participants
|
|
Sex: Female, Male
Male
|
33 Participants
n=56 Participants
|
24 Participants
n=44 Participants
|
57 Participants
n=100 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
PRIMARY outcome
Timeframe: baseline, 1 hour, and Day 1 dischargePost-Anesthesia Care Unity (PACU) pain scores at baseline, 1 hour, and on discharge from PACU. Pain score by visual analogue score, total scale from 0 to 10 with 10 being the worse pain.
Outcome measures
| Measure |
Oral Acetaminophen
n=56 Participants
Oral acetaminophen 975mg preoperatively and receive intravenous saline intraoperatively.
|
Acetaminophen IV Soln
n=44 Participants
Acetaminophen 1000mg IV Soln after induction of general anesthesia and placebo pills preoperatively
|
|---|---|---|
|
PACU Visual Analogue Pain Scores
Baseline
|
2.13 score on a scale
Standard Deviation 2.72
|
1.52 score on a scale
Standard Deviation 2.44
|
|
PACU Visual Analogue Pain Scores
1 hour
|
2.88 score on a scale
Standard Deviation 2.74
|
2.41 score on a scale
Standard Deviation 2.21
|
|
PACU Visual Analogue Pain Scores
Discharge from PACU, up to 2.5 hours
|
1.45 score on a scale
Standard Deviation 1.51
|
1.59 score on a scale
Standard Deviation 1.44
|
|
PACU Visual Analogue Pain Scores
6 hour post op
|
3.82 score on a scale
Standard Deviation 2.28
|
4.27 score on a scale
Standard Deviation 1.74
|
|
PACU Visual Analogue Pain Scores
24 hour post op
|
3.64 score on a scale
Standard Deviation 2.26
|
4.16 score on a scale
Standard Deviation 1.83
|
PRIMARY outcome
Timeframe: Day 1Total Morphine Milligram Equivalent (MME) use intraoperatively
Outcome measures
| Measure |
Oral Acetaminophen
n=56 Participants
Oral acetaminophen 975mg preoperatively and receive intravenous saline intraoperatively.
|
Acetaminophen IV Soln
n=44 Participants
Acetaminophen 1000mg IV Soln after induction of general anesthesia and placebo pills preoperatively
|
|---|---|---|
|
Total MME Intraoperatively
|
63.75 MME
Standard Deviation 21.33
|
57.24 MME
Standard Deviation 29.20
|
PRIMARY outcome
Timeframe: Day 1Total narcotic use in PACU expressed in total morphine milligram equivalents (MME)
Outcome measures
| Measure |
Oral Acetaminophen
n=56 Participants
Oral acetaminophen 975mg preoperatively and receive intravenous saline intraoperatively.
|
Acetaminophen IV Soln
n=44 Participants
Acetaminophen 1000mg IV Soln after induction of general anesthesia and placebo pills preoperatively
|
|---|---|---|
|
Total Narcotic Use in PACU.
|
11.33 MME
Standard Deviation 17.10
|
9.83 MME
Standard Deviation 11.99
|
SECONDARY outcome
Timeframe: up to 24 hours after PACU arrivalTime in PACU
Outcome measures
| Measure |
Oral Acetaminophen
n=56 Participants
Oral acetaminophen 975mg preoperatively and receive intravenous saline intraoperatively.
|
Acetaminophen IV Soln
n=44 Participants
Acetaminophen 1000mg IV Soln after induction of general anesthesia and placebo pills preoperatively
|
|---|---|---|
|
PACU Length of Stay
|
82.93 minutes
Standard Deviation 55.79
|
64.05 minutes
Standard Deviation 33.13
|
SECONDARY outcome
Timeframe: average 7 dayshome opiod use
Outcome measures
| Measure |
Oral Acetaminophen
n=56 Participants
Oral acetaminophen 975mg preoperatively and receive intravenous saline intraoperatively.
|
Acetaminophen IV Soln
n=44 Participants
Acetaminophen 1000mg IV Soln after induction of general anesthesia and placebo pills preoperatively
|
|---|---|---|
|
Patient Reported Total Narcotic Use Post-discharge
|
14.06 MME
Standard Deviation 14.02
|
17.56 MME
Standard Deviation 17.42
|
SECONDARY outcome
Timeframe: 7 days post surgeryPopulation: one missing survey
Patient satisfaction total scale from 1 to 10, with higher score indicating more satisfaction
Outcome measures
| Measure |
Oral Acetaminophen
n=56 Participants
Oral acetaminophen 975mg preoperatively and receive intravenous saline intraoperatively.
|
Acetaminophen IV Soln
n=43 Participants
Acetaminophen 1000mg IV Soln after induction of general anesthesia and placebo pills preoperatively
|
|---|---|---|
|
Patient Satisfaction.
|
5.05 score on a scale
Standard Deviation 2.18
|
6.20 score on a scale
Standard Deviation 3.01
|
Adverse Events
Oral Acetaminophen
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Acetaminophen IV Soln
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Alopi Patel
Icahn School of Medicine at Mount Sinai
Phone: (212) 523-6357
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place