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Ibuprofen Alone and in Combination With Acetaminophen for Treatment of Fever

This study has been completed.
Sponsor:
Collaborator:
Children Youth and Family Consortium
Information provided by (Responsible Party):
Ian M. Paul, M.D., M.Sc., Penn State University
ClinicalTrials.gov Identifier:
NCT00267293
First received: December 16, 2005
Last updated: May 8, 2012
Last verified: May 2012
History of Changes
Results First Received: July 22, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Fever
Interventions: Drug: Acetaminophen
Drug: Ibuprofen

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Group A: Ibuprofen Alone Time 0 Ibuprofen (10mg/kg)given. Temperature in °C measured hourly for 6 hours.
Group B: Ibuprofen and Acetaminophen time 0 child Ibuprofen (10mg/kg) and Acetaminophen (15 mg/kg)given. Temperature in °C measured hourly for 6 hours.
Group C: Ibuprofen Then Acetaminophen 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.

Participant Flow:   Overall Study
    Group A: Ibuprofen Alone     Group B: Ibuprofen and Acetaminophen     Group C: Ibuprofen Then Acetaminophen  
STARTED     20     20     20  
COMPLETED     20     20     20  
NOT COMPLETED     0     0     0  



  Baseline Characteristics
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Reporting Groups
  Description
Group A: Ibuprofen Alone Time 0 Ibuprofen (10mg/kg)given. Temperature in °C measured hourly for 6 hours.
Group B: Ibuprofen and Acetaminophen time 0 child Ibuprofen (10mg/kg) and Acetaminophen (15 mg/kg)given. Temperature in °C measured hourly for 6 hours.
Group C: Ibuprofen Then Acetaminophen 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 Total of all reporting groups

Baseline Measures
    Group A: Ibuprofen Alone     Group B: Ibuprofen and Acetaminophen     Group C: Ibuprofen Then Acetaminophen     Total  
Number of Participants  
[units: participants]
 		  20     20     20     60  
Age  
[units: participants]
 		       
<=18 years     20     20     20     60  
Between 18 and 65 years     0     0     0     0  
>=65 years     0     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation 		  3.2  ± 1.9     3.0  ± 1.9     4.0  ± 2.8     3.4  ± 2.2  
Gender  
[units: participants]
 		       
Female     8     10     13     31  
Male     12     10     7     29  
Region of Enrollment  
[units: participants]
 		       
United States     20     20     20     60  



  Outcome Measures

1.  Primary:   Child Temperature (Degrees C)Over 6 Hours   [ Time Frame: 6 hours ]
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  Serious Adverse Events
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  Other Adverse Events
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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.  


Results Point of Contact:  
Name/Title: Ian M Paul, MD, MSc
Organization: Penn State Children's Hospital
phone: 717-531-5656
e-mail: ipaul@hmc.psu.edu


No publications provided by Penn State University

Publications automatically indexed to this study:


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
Study First Received: December 16, 2005
Results First Received: July 22, 2011
Last Updated: May 8, 2012
Health Authority: United States: Institutional Review Board