Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 73 of 1877 for:    ACETAMINOPHEN

Intravenous Acetaminophen in Craniotomy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01598701
Recruitment Status : Completed
First Posted : May 15, 2012
Results First Posted : June 19, 2018
Last Update Posted : June 19, 2018
Sponsor:
Collaborator:
Mallinckrodt
Information provided by (Responsible Party):
Carlos Artime, The University of Texas Health Science Center, Houston

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Supportive Care
Condition Postoperative Pain
Interventions Drug: Acetaminophen
Drug: Placebo
Enrollment 100
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Intravenous Acetaminophen Placebo
Hide Arm/Group Description

Patients will be receive doses of 1000 mg/100 mL of IV Acetaminophen (OFIRMEV). The drug will be infused over 15 minutes.

Acetaminophen: Intravenous Acetaminophen, 1000 mg/100mL, Every 6 hours, Infused over 15 minutes.

Patients will be given 100 mL normal saline placebos at scheduled time intervals in place of IV acetaminophen.

Placebo: 100 mL 0.9% Sodium Chloride

Period Title: Overall Study
Started 50 50
Completed 45 41
Not Completed 5 9
Arm/Group Title Intravenous Acetaminophen Placebo Total
Hide Arm/Group Description

Patients will be receive doses of 1000 mg/100 mL of IV Acetaminophen (OFIRMEV). The drug will be infused over 15 minutes.

Acetaminophen: Intravenous Acetaminophen, 1000 mg/100mL, Every 6 hours, Infused over 15 minutes.

Patients will be given 100 mL normal saline placebos at scheduled time intervals in place of IV acetaminophen.

Placebo: 100 mL 0.9% Sodium Chloride

Total of all reporting groups
Overall Number of Baseline Participants 50 50 100
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 50 participants 50 participants 100 participants
50.0  (16.3) 51.5  (14.4) 50.75  (15.35)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 50 participants 50 participants 100 participants
Female
24
  48.0%
31
  62.0%
55
  55.0%
Male
26
  52.0%
19
  38.0%
45
  45.0%
1.Primary Outcome
Title Post-Operative Opioid Requirement
Hide Description Opioid Consumption will be monitored in the first 24 post-operative hours. All non-opioid analgesics are disallowed. Total opioid consumption was calculated based on morphine equivalents (MEs), where 1 mg of IV morphine was equivalent to 1 ME, and 1 mg IV hydromorphone was calculated as 7 MEs.
Time Frame 24 hours post-operatively
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Intravenous Acetaminophen Placebo
Hide Arm/Group Description:

Patients will be receive doses of 1000 mg/100 mL of IV Acetaminophen (OFIRMEV). The drug will be infused over 15 minutes.

Acetaminophen: Intravenous Acetaminophen, 1000 mg/100mL, Every 6 hours, Infused over 15 minutes.

Patients will be given 100 mL normal saline placebos at scheduled time intervals in place of IV acetaminophen.

Placebo: 100 mL 0.9% Sodium Chloride

Overall Number of Participants Analyzed 45 41
Median (Inter-Quartile Range)
Unit of Measure: Morphine Equivalents
11.0
(2 to 21)
10.1
(1 to 16.7)
2.Secondary Outcome
Title Post-Operative Pain
Hide Description Patients will be assessed for pain using a Visual Analogue Scale (VAS) Scale at set time points after surgery (0,1,2,4,8,12,16,20,24 hours post-operatively). The Visual Analogue Scale (VAS) scale was measured on a scale of 0 - 10 (0 = no pain, 1-3 = mild, 4-6 = moderate, 7-10 = severe). Higher values on the VAS represent a worse outcome. The two rows below report: 1. the average VAS score for the least amount of pain reported per group and 2. the average VAS score of the worst amount of pain reported per group.
Time Frame 24 Hours Post-Operatively
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Intravenous Acetaminophen Placebo
Hide Arm/Group Description:

Patients will be receive doses of 1000 mg/100 mL of IV Acetaminophen (OFIRMEV). The drug will be infused over 15 minutes.

Acetaminophen: Intravenous Acetaminophen, 1000 mg/100mL, Every 6 hours, Infused over 15 minutes.

Patients will be given 100 mL normal saline placebos at scheduled time intervals in place of IV acetaminophen.

Placebo: 100 mL 0.9% Sodium Chloride

Overall Number of Participants Analyzed 45 41
Mean (Standard Deviation)
Unit of Measure: units on a scale
Least amount of pain reported 1.4  (1.8) 2.6  (2.7)
Worst amount of pain reported 6.3  (2.5) 6.4  (3.2)
3.Secondary Outcome
Title Post-Operative Side Effects
Hide Description Patients will be monitored for 24 hours post-operatively to detect the incidence of any drug or opioid-related side effects. These side effects were not considered to be adverse events.
Time Frame 24 Hours Post-Operatively
Hide Outcome Measure Data
Hide Analysis Population Description
The # analyzed does not match the # who completed or the overall # analyzed because data on all side effects was not collected for all participants who completed, either due to lack of collection of data by research/nursing staff (for emesis) or due to lack of reporting by participants on a questionnaire(for itching, dizziness, and drowsiness).
Arm/Group Title Intravenous Acetaminophen Placebo
Hide Arm/Group Description:

Patients will be receive doses of 1000 mg/100 mL of IV Acetaminophen (OFIRMEV). The drug will be infused over 15 minutes.

Acetaminophen: Intravenous Acetaminophen, 1000 mg/100mL, Every 6 hours, Infused over 15 minutes.

Patients will be given 100 mL normal saline placebos at scheduled time intervals in place of IV acetaminophen.

Placebo: 100 mL 0.9% Sodium Chloride

Overall Number of Participants Analyzed 45 40
Measure Type: Count of Participants
Unit of Measure: Participants
Emesis Number Analyzed 45 participants 40 participants
23
  51.1%
20
  50.0%
Itching Number Analyzed 42 participants 37 participants
8
  19.0%
5
  13.5%
Dizziness Number Analyzed 42 participants 37 participants
14
  33.3%
14
  37.8%
Drowsiness Number Analyzed 42 participants 37 participants
24
  57.1%
19
  51.4%
4.Secondary Outcome
Title Time to Extubation at Emergence From Anesthesia
Hide Description [Not Specified]
Time Frame Time from of discontinuation of anesthetic to time of extubation, an average of 7 minutes
Hide Outcome Measure Data
Hide Analysis Population Description
The number analyzed is greater than the number completed because this data was collected for more patients than completed the study, and all data that was collected is reported here.
Arm/Group Title Intravenous Acetaminophen Placebo
Hide Arm/Group Description:

Patients will be receive doses of 1000 mg/100 mL of IV Acetaminophen (OFIRMEV). The drug will be infused over 15 minutes.

Acetaminophen: Intravenous Acetaminophen, 1000 mg/100mL, Every 6 hours, Infused over 15 minutes.

Patients will be given 100 mL normal saline placebos at scheduled time intervals in place of IV acetaminophen.

Placebo: 100 mL 0.9% Sodium Chloride

Overall Number of Participants Analyzed 48 45
Median (Inter-Quartile Range)
Unit of Measure: minutes
6
(3 to 13)
8
(5 to 12)
5.Secondary Outcome
Title Time for Patient to Meet Post-anesthesia Care Unit (PACU) Discharge Criteria
Hide Description [Not Specified]
Time Frame From time of entry to PACU to time to meet PACU discharge criteria, an average of 12 minutes
Hide Outcome Measure Data
Hide Analysis Population Description
The number analyzed is greater than the number completed because this data was collected for more patients than completed the study, and all data that was collected is reported here.
Arm/Group Title Intravenous Acetaminophen Placebo
Hide Arm/Group Description:

Patients will be receive doses of 1000 mg/100 mL of IV Acetaminophen (OFIRMEV). The drug will be infused over 15 minutes.

Acetaminophen: Intravenous Acetaminophen, 1000 mg/100mL, Every 6 hours, Infused over 15 minutes.

Patients will be given 100 mL normal saline placebos at scheduled time intervals in place of IV acetaminophen.

Placebo: 100 mL 0.9% Sodium Chloride

Overall Number of Participants Analyzed 46 43
Mean (Standard Deviation)
Unit of Measure: minutes
11.4  (7.2) 13.5  (8.4)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Intravenous Acetaminophen Placebo
Hide Arm/Group Description

Patients will be receive doses of 1000 mg/100 mL of IV Acetaminophen (OFIRMEV). The drug will be infused over 15 minutes.

Acetaminophen: Intravenous Acetaminophen, 1000 mg/100mL, Every 6 hours, Infused over 15 minutes.

Patients will be given 100 mL normal saline placebos at scheduled time intervals in place of IV acetaminophen.

Placebo: 100 mL 0.9% Sodium Chloride

All-Cause Mortality
Intravenous Acetaminophen Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Intravenous Acetaminophen Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/50 (0.00%)      0/50 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Intravenous Acetaminophen Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/50 (0.00%)      1/50 (2.00%)    
Cardiac disorders     
Bradycardia *  0/50 (0.00%)  0 1/50 (2.00%)  1
*
Indicates events were collected by non-systematic assessment
Not powered to detect differences in pain score. Patients were not given a patient-controlled analgesia device; rather, administration of morphine was dependent on nurse administration.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Carlos Artime, MD
Organization: University of Texas Health Science Center at Houston
Phone: 713-500-6200
EMail: Carlos.Artime@uth.tmc.edu
Layout table for additonal information
Responsible Party: Carlos Artime, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier: NCT01598701     History of Changes
Other Study ID Numbers: HSC-MS-12-0055
First Submitted: May 9, 2012
First Posted: May 15, 2012
Results First Submitted: February 28, 2017
Results First Posted: June 19, 2018
Last Update Posted: June 19, 2018