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Trial record 8 of 1879 for:    Acetaminophen

Efficacy of Oral vs. Intravenous Acetaminophen

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ClinicalTrials.gov Identifier: NCT02643394
Recruitment Status : Completed
First Posted : December 31, 2015
Results First Posted : May 7, 2018
Last Update Posted : July 3, 2018
Sponsor:
Information provided by (Responsible Party):
University of Texas Southwestern Medical Center

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Treatment
Condition Postoperative Pain
Interventions Drug: Oral Acetaminophen
Drug: Intravenous acetaminophen
Enrollment 110
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Oral Acetaminophen Intravenous Acetaminophen
Hide Arm/Group Description

Oral Acetaminophen 1-hour before surgery

Oral Acetaminophen: 1000mg oral acetaminophen + 400mg oral celecoxib given within one hour of incision

Intravenous Acetaminophen within 1-hour prior to anesthetic emergence

Intravenous acetaminophen: 400mg oral celecoxib given within one hour of incision + 1000mg IV acetaminophen within one hour prior to anesthetic emergence.

Period Title: Overall Study
Started 55 55
Completed 51 50
Not Completed 4 5
Reason Not Completed
Protocol Violation             4             5
Arm/Group Title Oral Acetaminophen Intravenous Acetaminophen Total
Hide Arm/Group Description

Oral Acetaminophen 1-hour before surgery

Oral Acetaminophen: 1000mg oral acetaminophen + 400mg oral celecoxib given within one hour of incision

Intravenous Acetaminophen within 1-hour prior to anesthetic emergence

Intravenous acetaminophen: 400mg oral celecoxib given within one hour of incision + 1000mg IV acetaminophen within one hour prior to anesthetic emergence.

Total of all reporting groups
Overall Number of Baseline Participants 55 55 110
Hide Baseline Analysis Population Description
Adult patients undergoing sinus surgery at a single major academic medical center
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 55 participants 55 participants 110 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
44
  80.0%
42
  76.4%
86
  78.2%
>=65 years
11
  20.0%
13
  23.6%
24
  21.8%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 55 participants 55 participants 110 participants
51.5  (16.3) 54.0  (15.7) 52.7  (16.0)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 55 participants 55 participants 110 participants
Female
21
  38.2%
20
  36.4%
41
  37.3%
Male
34
  61.8%
35
  63.6%
69
  62.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 55 participants 55 participants 110 participants
55 55 110
1.Primary Outcome
Title Postoperative Pain Score on the Scale of 10 (0=No Pain and 10=Worst Pain)
Hide Description Pain score on the scale of 10 at 1-h postoperatively in the Post-Anesthesia Care Unit (PACU)
Time Frame 1-h postoperatively
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects undergoing Functional Endoscopic Sinus Surgery were enrolled to the study.
Arm/Group Title Oral Acetaminophen Intravenous Acetaminophen
Hide Arm/Group Description:

Oral Acetaminophen 1-hour before surgery

Oral Acetaminophen: 1000mg oral acetaminophen + 400mg oral celecoxib given within one hour of incision

Intravenous Acetaminophen within 1-hour prior to anesthetic emergence

Intravenous acetaminophen: 400mg oral celecoxib given within one hour of incision + 1000mg IV acetaminophen within one hour prior to anesthetic emergence.

Overall Number of Participants Analyzed 51 50
Median (Inter-Quartile Range)
Unit of Measure: units on a scale
2
(0 to 3)
2
(0 to 5)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Oral Acetaminophen, Intravenous Acetaminophen
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.252
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
2.Secondary Outcome
Title Morphine Equivalents of Postoperative Opioid Usage
Hide Description Total amount of postoperative opioid usage at Postoperative Anesthesia Care Unit (PACU), an expected average of 6 hours
Time Frame an expected average of 6 hours
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects undergoing Functional Endoscopic Sinus Surgery were enrolled to the study.
Arm/Group Title Oral Acetaminophen Intravenous Acetaminophen
Hide Arm/Group Description:

Oral Acetaminophen 1-hour before surgery

Oral Acetaminophen: 1000mg oral acetaminophen + 400mg oral celecoxib given within one hour of incision

Intravenous Acetaminophen within 1-hour prior to anesthetic emergence

Intravenous acetaminophen: 400mg oral celecoxib given within one hour of incision + 1000mg IV acetaminophen within one hour prior to anesthetic emergence.

Overall Number of Participants Analyzed 51 50
Median (Inter-Quartile Range)
Unit of Measure: Morphine equivalent (mg)
5
(0 to 10)
5
(0 to 14.8)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Oral Acetaminophen, Intravenous Acetaminophen
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.402
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Time Frame Through 24h post-operatively
Adverse Event Reporting Description Patient phone call at 24h
 
Arm/Group Title Oral Acetaminophen Intravenous Acetaminophen
Hide Arm/Group Description

Oral Acetaminophen 1-hour before surgery

Oral Acetaminophen: 1000mg oral acetaminophen + 400mg oral celecoxib given within one hour of incision

Intravenous Acetaminophen within 1-hour prior to anesthetic emergence

Intravenous acetaminophen: 400mg oral celecoxib given within one hour of incision + 1000mg IV acetaminophen within one hour prior to anesthetic emergence.

All-Cause Mortality
Oral Acetaminophen Intravenous Acetaminophen
Affected / at Risk (%) Affected / at Risk (%)
Total   0/51 (0.00%)      0/50 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Oral Acetaminophen Intravenous Acetaminophen
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/51 (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%
Oral Acetaminophen Intravenous Acetaminophen
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/51 (5.88%)      6/50 (12.00%)    
Gastrointestinal disorders     
Nausea  [1]  3/51 (5.88%)  3 6/50 (12.00%)  6
Indicates events were collected by systematic assessment
[1]
Nausea following PACU discharge (assessed at 24h post-operatively)
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: David McDonagh, MD
Organization: UT Southwestern Medical Center
Phone: 214-648-8083
EMail: david.mcdonagh@utsouthwestern.edu
Layout table for additonal information
Responsible Party: University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT02643394     History of Changes
Other Study ID Numbers: 052015-068
First Submitted: June 2, 2015
First Posted: December 31, 2015
Results First Submitted: November 10, 2017
Results First Posted: May 7, 2018
Last Update Posted: July 3, 2018