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The Effect of Intravenous Acetaminophen on Post-Operative Pain After Craniotomy

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ClinicalTrials.gov Identifier: NCT03445390
Recruitment Status : Completed
First Posted : February 26, 2018
Results First Posted : March 1, 2019
Last Update Posted : March 1, 2019
Sponsor:
Information provided by (Responsible Party):
Mark Burbridge, Stanford University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Double (Participant, Care Provider);   Primary Purpose: Treatment
Condition Pain
Interventions Drug: Acetaminophen
Drug: Placebo
Enrollment 27
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Acetaminophen First, Then Placebo Placebo First, Then Acetaminophen
Hide Arm/Group Description 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. 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.
Period Title: First Intervention
Started 14 13
Completed 12 11
Not Completed 2 2
Period Title: Second Intervention
Started 12 11
Completed 10 10
Not Completed 2 1
Arm/Group Title All Study Participants
Hide Arm/Group Description 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.
Overall Number of Baseline Participants 20
Hide Baseline Analysis Population Description
Participants who completed both interventions were included in the analysis.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants
<=18 years
0
   0.0%
Between 18 and 65 years
20
 100.0%
>=65 years
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants
Female
16
  80.0%
Male
4
  20.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants
American Indian or Alaska Native
0
   0.0%
Asian
6
  30.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
2
  10.0%
White
12
  60.0%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 20 participants
20
1.Primary Outcome
Title Post-operative Opioid Consumption
Hide Description From nursing records how much opioid was administered to each patient post-operatively. Opioid use was measured in micrograms (ug) of fentanyl.
Time Frame Up to 24 hours post-operative
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who completed both interventions were included in the analysis.
Arm/Group Title Acetaminophen Placebo
Hide Arm/Group Description:
Patients were administered intravenous acetaminophen (1 g IV) twice.
Patients were administered placebo to match acetaminophen.
Overall Number of Participants Analyzed 20 20
Mean (Standard Deviation)
Unit of Measure: ug
228  (125) 312  (165)
2.Primary Outcome
Title Post-operative Pain
Hide Description 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.
Time Frame Up to 24 hours post-operative
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who completed both interventions were included in the analysis.
Arm/Group Title Acetaminophen Placebo
Hide Arm/Group Description:
Patients were administered intravenous acetaminophen (1 g IV) twice.
Patients were administered placebo to match acetaminophen.
Overall Number of Participants Analyzed 20 20
Mean (Standard Deviation)
Unit of Measure: units on a scale
Post-operative hour 0 to 12 3.4  (2.6) 3.8  (1.8)
Post-operative hour 13 to 24 2.7  (2.5) 2.6  (1.8)
Post-operative hour 0 to 24 3.1  (2.4) 3.2  (1.7)
3.Secondary Outcome
Title Count of Participants Requiring Anti-emetic Administration
Hide Description [Not Specified]
Time Frame Up to 24 hours post-operative
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who completed both interventions were included in the analysis.
Arm/Group Title Acetaminophen Placebo
Hide Arm/Group Description:
Patients were administered intravenous acetaminophen (1 g IV) twice.
Patients were administered placebo to match acetaminophen.
Overall Number of Participants Analyzed 20 20
Measure Type: Count of Participants
Unit of Measure: Participants
20
 100.0%
20
 100.0%
Time Frame Up to 2 weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Acetaminophen Placebo
Hide Arm/Group Description Patients were administered intravenous acetaminophen (1 g IV) twice. Patients were administered placebo to match acetaminophen.
All-Cause Mortality
Acetaminophen Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   2/25 (8.00%)   2/25 (8.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Acetaminophen Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/25 (0.00%)   0/25 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Acetaminophen Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/25 (0.00%)   0/25 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Dr. Mark Burbridge
Organization: Stanford University
Phone: (650) 353-8484
Responsible Party: Mark Burbridge, Stanford University
ClinicalTrials.gov Identifier: NCT03445390     History of Changes
Other Study ID Numbers: 27467
First Submitted: February 20, 2018
First Posted: February 26, 2018
Results First Submitted: December 6, 2018
Results First Posted: March 1, 2019
Last Update Posted: March 1, 2019