Oral Versus Rectal Ibuprofen for Fever in Young Children - a Randomized Control Study.
Recruitment status was: Recruiting
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Oral Versus Rectal Ibuprofen for Fever in Young Children - a Randomized Control Study.|
- Maximal change in temperature during the 4-hour period after enrollment. [ Time Frame: 4 hours ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
|Study Start Date:||September 2008|
|Estimated Study Completion Date:||June 2011|
|Estimated Primary Completion Date:||December 2010 (Final data collection date for primary outcome measure)|
Drug: Ibuprofen suppository
5-10mg/Kg of ibuprofen
Active Comparator: 2
Drug: Ibuprofen Suspension
Please refer to this study by its ClinicalTrials.gov identifier: NCT00729976
|Assaf Harofeh Medical Center|
|Zerifin, Israel, 70300|