Ibuprofen Suppositories Administration in Infants and Children

Phase 4

• Conditions: Fever

• Registration Number: NCT00938509
• Lead Sponsor: Soroka University Medical Center

Brief Summary

The study will evaluate the efficacy of Ibuprofen administered as suppositories in the treatment of fever in infants and children. Ibuprofen as suppositories is not yet registered in Israel, although widely used in Europe.

Detailed Description

The drug will be used in 100 consecutive infants and children admitted with fever at the pediatric ER of the Soroka Medical Center. The information on the drug efficacy will be collected in appropriate parental questionnaires.

Study Timeline

• Status Verified: 2009-07
• Study Start: 2009-07
• Study First Submitted: 2009-07-13
• Study First Submitted QC: 2009-07-13
• Study First Posted: 2009-07-14
• Last Update Submitted: 2009-07-21
• Last Update Posted: 2009-07-22
• Primary Completion: 2009-10
• Study Completion: 2009-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Infants and children with rectal temperature > 38.5 C

Exclusion Criteria

• Infants < 6 months of age

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Fever decrease	1 day

Trial Locations

Locations (1)

pediatric emergency room, SOROKA MEDICAL CENTER; 🇮🇱 Beer Sheva, Israel