Fever
Conditions
Keywords
Ibuprofen, Suppository, febrile children
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.
Interventions
5-10mg/Kg of ibuprofen
5-10mg/Kg
Sponsors
Assaf-Harofeh Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
3 Months to 5 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Maximal change in temperature during the 4-hour period after enrollment. | 4 hours |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
Countries
Israel
Contacts
Primary ContactEran Kozer, MD
Backup ContactEhud Rosenbloom, MD
Outcome results
None listed