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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

  Participant Flow

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

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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.
Total Total of all reporting groups

Baseline Measures
   Group A: Ibuprofen Alone   Group B: Ibuprofen and Acetaminophen   Group C: Ibuprofen Then Acetaminophen   Total 
Overall Participants Analyzed 
[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 ]


  Serious Adverse Events


  Other Adverse Events


  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.


  More Information

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
e-mail: ipaul@hmc.psu.edu


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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