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

Study Status: Terminated
Recruit Status: Unknown status
Study Type: Interventional

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

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 Summary:
Sponsor: Assaf-Harofeh Medical Center

Current Primary Outcome: Maximal change in temperature during the 4-hour period after enrollment. [ Time Frame: 4 hours ]

Original Primary Outcome: Same as current

Current 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. [ Time Frame: 4 h ]

Original Secondary Outcome: Same as current

Information By: Assaf-Harofeh Medical Center

Dates:
Date Received: August 6, 2008
Date Started: September 2008
Date Completion: June 2011
Last Updated: April 4, 2011
Last Verified: March 2010