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Ibuprofen Alone and in Combination With Acetaminophen for Treatment of Fever

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ClinicalTrials.gov Identifier: NCT00267293
Recruitment Status : Completed
First Posted : December 20, 2005
Results First Posted : May 9, 2012
Last Update Posted : May 9, 2012
Sponsor:
Collaborator:
Children Youth and Family Consortium
Information provided by (Responsible Party):
Ian M. Paul, M.D., M.Sc., Penn State University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Fever
Interventions Drug: Acetaminophen
Drug: Ibuprofen
Enrollment 60
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Group A: Ibuprofen Alone Group B: Ibuprofen and Acetaminophen Group C: Ibuprofen Then Acetaminophen
Hide Arm/Group Description Time 0 Ibuprofen (10mg/kg)given. Temperature in °C measured hourly for 6 hours. time 0 child Ibuprofen (10mg/kg) and Acetaminophen (15 mg/kg)given. Temperature in °C measured hourly for 6 hours. Time 0 child is given Ibuprofen (10mg/kg) and at time 3 hours is given (15 mg/kg. Temperature in °C measured hourly for 6 hours.
Period Title: Overall Study
Started 20 20 20
Completed 20 20 20
Not Completed 0 0 0
Arm/Group Title Group A: Ibuprofen Alone Group B: Ibuprofen and Acetaminophen Group C: Ibuprofen Then Acetaminophen Total
Hide Arm/Group Description Time 0 Ibuprofen (10mg/kg)given. Temperature in °C measured hourly for 6 hours. time 0 child Ibuprofen (10mg/kg) and Acetaminophen (15 mg/kg)given. Temperature in °C measured hourly for 6 hours. Time 0 child is given Ibuprofen (10mg/kg) and at time 3 hours is given (15 mg/kg. Temperature in °C measured hourly for 6 hours. Total of all reporting groups
Overall Number of Baseline Participants 20 20 20 60
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants 20 participants 20 participants 60 participants
<=18 years
20
 100.0%
20
 100.0%
20
 100.0%
60
 100.0%
Between 18 and 65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 20 participants 20 participants 20 participants 60 participants
3.2  (1.9) 3.0  (1.9) 4.0  (2.8) 3.4  (2.2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants 20 participants 20 participants 60 participants
Female
8
  40.0%
10
  50.0%
13
  65.0%
31
  51.7%
Male
12
  60.0%
10
  50.0%
7
  35.0%
29
  48.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 20 participants 20 participants 20 participants 60 participants
20 20 20 60
1.Primary Outcome
Title Child Temperature (Degrees C)Over 6 Hours
Hide Description Temperature was measured hourly using a temporal thermometer to monitor the child's temperature in degrees C. Temperature of 38 degrees C or higher was considered febrile.
Time Frame 6 hours
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis was ITT per sample size calculation at 80% power.
Arm/Group Title Group A: Ibuprofen Alone Group B: Ibuprofen and Acetaminophen Group C: Ibuprofen Then Acetaminophen
Hide Arm/Group Description:
Time 0 Ibuprofen (10mg/kg)given. Temperature in °C measured hourly for 6 hours.
time 0 child Ibuprofen (10mg/kg) and Acetaminophen (15 mg/kg)given. Temperature in °C measured hourly for 6 hours.
Time 0 child is given Ibuprofen (10mg/kg) and at time 3 hours is given (15 mg/kg. Temperature in °C measured hourly for 6 hours.
Overall Number of Participants Analyzed 20 20 20
Mean (Standard Deviation)
Unit of Measure: degrees Celcius
38.5  (1.5) 37.2  (0.6) 36.9  (0.3)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Group A: Ibuprofen Alone, Group B: Ibuprofen and Acetaminophen, Group C: Ibuprofen Then Acetaminophen
Comments Power for 80%
Type of Statistical Test Non-Inferiority or Equivalence
Comments Power for 80%
Statistical Test of Hypothesis P-Value <0.001
Comments comparision of mean temperatures from repeated exposure. At hour 6 temperature
Method Mixed Models Analysis
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Group A: Ibuprofen Alone, Group B: Ibuprofen and Acetaminophen, Group C: Ibuprofen Then Acetaminophen
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <.0001
Comments Binary outcome <38C and >=38C
Method Chi-squared
Comments [Not Specified]
Time Frame 6 hours
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Group A: Ibuprofen Alone Group B: Ibuprofen and Acetaminophen Group C: Ibuprofen Then Acetaminophen
Hide Arm/Group Description Time 0 Ibuprofen (10mg/kg)given. Temperature in °C measured hourly for 6 hours. time 0 child Ibuprofen (10mg/kg) and Acetaminophen (15 mg/kg)given. Temperature in °C measured hourly for 6 hours. Time 0 child is given Ibuprofen (10mg/kg) and at time 3 hours is given (15 mg/kg. Temperature in °C measured hourly for 6 hours.
All-Cause Mortality
Group A: Ibuprofen Alone Group B: Ibuprofen and Acetaminophen Group C: Ibuprofen Then Acetaminophen
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Group A: Ibuprofen Alone Group B: Ibuprofen and Acetaminophen Group C: Ibuprofen Then Acetaminophen
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/20 (0.00%)   0/20 (0.00%)   0/20 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Group A: Ibuprofen Alone Group B: Ibuprofen and Acetaminophen Group C: Ibuprofen Then Acetaminophen
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/20 (0.00%)   0/20 (0.00%)   0/20 (0.00%) 
Relatively small sample size. Underpowered to evaluate effect oon discomfort and pain. The 6 hour observation allowed for evaluation of single cycle of drug. Did not evaluate the effect of multiple doses over a longer observation period.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Ian M Paul, MD, MSc
Organization: Penn State Children's Hospital
Phone: 717-531-5656
Responsible Party: Ian M. Paul, M.D., M.Sc., Penn State University
ClinicalTrials.gov Identifier: NCT00267293     History of Changes
Other Study ID Numbers: HY03-127
First Submitted: December 16, 2005
First Posted: December 20, 2005
Results First Submitted: July 22, 2011
Results First Posted: May 9, 2012
Last Update Posted: May 9, 2012