Trial Outcomes & Findings for The Effect of Intravenous Acetaminophen on Post-Operative Pain After Craniotomy (NCT NCT03445390)
NCT ID: NCT03445390
Last Updated: 2019-03-01
Results Overview
From nursing records how much opioid was administered to each patient post-operatively. Opioid use was measured in micrograms (ug) of fentanyl.
COMPLETED
PHASE4
27 participants
Up to 24 hours post-operative
2019-03-01
Participant Flow
Participant milestones
| Measure |
Acetaminophen First, Then Placebo
Patients were administered intravenous acetaminophen (1 g IV) twice in one surgery and placebo to match in the other. Patients were randomly assigned to acetaminophen first or placebo first.
|
Placebo First, Then Acetaminophen
Patients were administered intravenous acetaminophen (1 g IV) twice in one surgery and placebo to match in the other. Patients were randomly assigned to acetaminophen first or placebo first.
|
|---|---|---|
|
First Intervention
STARTED
|
14
|
13
|
|
First Intervention
COMPLETED
|
12
|
11
|
|
First Intervention
NOT COMPLETED
|
2
|
2
|
|
Second Intervention
STARTED
|
12
|
11
|
|
Second Intervention
COMPLETED
|
10
|
10
|
|
Second Intervention
NOT COMPLETED
|
2
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The Effect of Intravenous Acetaminophen on Post-Operative Pain After Craniotomy
Baseline characteristics by cohort
| Measure |
All Study Participants
n=20 Participants
Patients were administered intravenous acetaminophen (1 g IV) twice in one surgery and placebo to match in the other. Patients were randomly assigned to acetaminophen first or placebo first.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
20 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
12 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
20 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 24 hours post-operativePopulation: Participants who completed both interventions were included in the analysis.
From nursing records how much opioid was administered to each patient post-operatively. Opioid use was measured in micrograms (ug) of fentanyl.
Outcome measures
| Measure |
Acetaminophen
n=20 Participants
Patients were administered intravenous acetaminophen (1 g IV) twice.
|
Placebo
n=20 Participants
Patients were administered placebo to match acetaminophen.
|
|---|---|---|
|
Post-operative Opioid Consumption
|
228 ug
Standard Deviation 125
|
312 ug
Standard Deviation 165
|
PRIMARY outcome
Timeframe: Up to 24 hours post-operativePopulation: Participants who completed both interventions were included in the analysis.
Patients were asked to rate their pain on a scale of 1 to 10, with 1 being least pain, and 10 being most pain. Pain was assessed continually once per hour during the post-operative period and the average pain score calculated per participant. The average of the participants' average scores is presented for each group.
Outcome measures
| Measure |
Acetaminophen
n=20 Participants
Patients were administered intravenous acetaminophen (1 g IV) twice.
|
Placebo
n=20 Participants
Patients were administered placebo to match acetaminophen.
|
|---|---|---|
|
Post-operative Pain
Post-operative hour 0 to 12
|
3.4 units on a scale
Standard Deviation 2.6
|
3.8 units on a scale
Standard Deviation 1.8
|
|
Post-operative Pain
Post-operative hour 13 to 24
|
2.7 units on a scale
Standard Deviation 2.5
|
2.6 units on a scale
Standard Deviation 1.8
|
|
Post-operative Pain
Post-operative hour 0 to 24
|
3.1 units on a scale
Standard Deviation 2.4
|
3.2 units on a scale
Standard Deviation 1.7
|
SECONDARY outcome
Timeframe: Up to 24 hours post-operativePopulation: Participants who completed both interventions were included in the analysis.
Outcome measures
| Measure |
Acetaminophen
n=20 Participants
Patients were administered intravenous acetaminophen (1 g IV) twice.
|
Placebo
n=20 Participants
Patients were administered placebo to match acetaminophen.
|
|---|---|---|
|
Count of Participants Requiring Anti-emetic Administration
|
20 Participants
|
20 Participants
|
Adverse Events
Acetaminophen
Placebo
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