Oral Versus Rectal Ibuprofen for Fever in Young Children - a Randomized Control Study.
Information source: Assaf-Harofeh Medical Center
Information obtained from ClinicalTrials.gov on November 03, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Fever
Intervention: Ibuprofen suppository (Drug); Ibuprofen Suspension (Drug)
Phase: Phase 4
Status: Not yet recruiting
Sponsored by: Assaf-Harofeh Medical Center Overall contact:
Eran Kozer, MD, Phone: 972 8 9779916, Email: erank@asaf.health.gov.il
Summary
Fever is one of the most common symptoms in pediatrics and one of the most common reasons for
visits in pediatricians' office and pediatric emergency departments. Many parents consider
fever to be the most terrifying symptom.
Ibuprofen is an effective and safe treatment for febrile children. Until recently ibuprofen
was available only in tablets suspension and as a liquid gel. All these dosage form are
administered orally. Rectal suppositories are often essential for treating febrile children
who cannot take medications by mouth (e. g vomiting). In the current study we aim to compare
the effect on fever of ibuprofen given as suspension with ibuprofen suppositories.
Clinical Details
Official title: Oral Versus Rectal Ibuprofen for Fever in Young Children - a Randomized Control Study.
Study design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Primary outcome: Maximal change in temperature during the 4-hour period after enrollment.
Secondary outcome: Proportion of patients with a drop of at least 1°C and 2°C in mean temperature at 4h.
Decrement in fever at each time point, and the area under the temperature (versus time) curve.
Proportion of patients with temperature < 38 at 4 hours.
Eligibility
Minimum age: 3 Months.
Maximum age: 5 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
Age: 3 mo- 4 years
- Weight 6 - 18 kg
- Rectal temperature > 38. 50
Exclusion Criteria:
- Treatment with acetaminophen in the last 4 hours
- Treatment with Ibuprofen in the last 6 hours
- Unable to take oral or rectal medications
- Hypersensitivity to ibuprofen
- Renal failure
- Liver disease
- Rectal temperature can't be measured (due to anatomical or medical problem)
- Informed consent could not be granted
Locations and Contacts
Eran Kozer, MD, Phone: 972 8 9779916, Email: erank@asaf.health.gov.il
Assaf Harofeh, Zerifin 70300, Israel
Additional Information
Starting date: September 2008
Ending date: June 2010
Last updated: August 7, 2008
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