Oral Versus Rectal Ibuprofen for Fever in Young Children - a Randomized Control Study.
|ClinicalTrials.gov Identifier: NCT00729976|
Recruitment Status : Unknown
Verified March 2010 by Assaf-Harofeh Medical Center.
Recruitment status was: Recruiting
First Posted : August 8, 2008
Last Update Posted : April 5, 2011
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.
|Condition or disease||Intervention/treatment||Phase|
|Fever||Drug: Ibuprofen suppository Drug: Ibuprofen Suspension||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Oral Versus Rectal Ibuprofen for Fever in Young Children - a Randomized Control Study.|
|Study Start Date :||September 2008|
|Estimated Primary Completion Date :||December 2010|
|Estimated Study Completion Date :||June 2011|
Drug: Ibuprofen suppository
5-10mg/Kg of ibuprofen
Active Comparator: 2
Drug: Ibuprofen Suspension
- Maximal change in temperature during the 4-hour period after enrollment. [ Time Frame: 4 hours ]
- 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 ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00729976
|Contact: Eran Kozer, MD||972 8 firstname.lastname@example.org|
|Contact: Ehud Rosenbloom, MD||972 8 email@example.com|
|Assaf Harofeh Medical Center||Recruiting|
|Zerifin, Israel, 70300|
|Contact: Eran Kozer, MD 97289779916 firstname.lastname@example.org|