Status:
COMPLETED
Ibuprofen Alone and in Combination With Acetaminophen for Treatment of Fever
Lead Sponsor:
Penn State University
Collaborating Sponsors:
Children Youth and Family Consortium
Conditions:
Fever
Eligibility:
All Genders
6-7 years
Phase:
PHASE4
Brief Summary
Currently, when a child has fever either ibuprofen (e.g. Motrin, Advil) or acetaminophen (e.g. Tylenol) is given. Both Ibuprofen and Acetaminophen are approved for over the counter use for treatment o...
Detailed Description
Despite a lack of evidence to support their fears, a majority of parents, pediatricians, and pediatric nurses believe that fever can be dangerous to a child. This "fever phobia" has caused a majority ...
Eligibility Criteria
Inclusion
- Age 6 months - 7 years of age at time of the fever.
- Initial temperature of 38.0C (100.4F) or more.
- Ability to cooperate with serial temporal artery temperature measurements.
- Ability to take medications by mouth.
- Willingness of the child's guardian/sponsor to give informed consent
Exclusion
- Patients who have received acetaminophen within 6 hours of presentation, or ibuprofen, aspirin, or other non-steroidal anti-inflammatory medications within 8 hours of presentation.
- Patients \>=3 years of age that have received narcotics in the previous 24 hours.
- Children with weight \>60 kg. Treatment of children with weights \>60 kg will result in greater than recommended adult doses of the medications.
- History of adverse reaction to any study medication ingredient.
- History of diabetes mellitis, renal dysfunction, hepatic dysfunction, or thrombocytopenia.
- Presence of moderate or severe dehydration.
- Inclusion in the trial on 3 previous occasions
- Medical judgment that the severity of the underlying illness prohibits inclusion.
Key Trial Info
Start Date :
January 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2009
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00267293
Start Date
January 1 2006
End Date
June 1 2009
Last Update
May 9 2012
Active Locations (1)
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1
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States, 17033-0850