Oral Versus Rectal Ibuprofen for Fever in Young Children - a Randomized Control Study.

Phase 4

• Conditions: Fever
• Interventions: Drug: Ibuprofen suppository; Drug: Ibuprofen Suspension

• Registration Number: NCT00729976
• Lead Sponsor: Assaf-Harofeh Medical Center

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-08-06
• Study First Submitted QC: 2008-08-07
• Study First Posted: 2008-08-08
• Study Start: 2008-09
• Status Verified: 2010-03
• Primary Completion: 2010-12
• Last Update Submitted: 2011-04-04
• Last Update Posted: 2011-04-05
• Study Completion: 2011-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Ibuprofen suppository	Ibuprofen Suppository
2	Ibuprofen Suspension	Ibuprofen suspension

Primary Outcome Measures

Name	Time	Method
Maximal change in temperature during the 4-hour period after enrollment.	4 hours

Secondary Outcome Measures

Name	Time	Method
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.	4 h

Trial Locations

Locations (1)

Assaf Harofeh Medical Center; 🇮🇱 Zerifin, Israel