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

Assaf-Harofeh Medical Center40 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Fever

Interventions

Eligibility

Sex: ALLMin age: 3 MonthsMax age: 5 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Maximal change in temperature during the 4-hour period after enrollment.

Time frame: 4 hours

Secondary Outcomes

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

Central Contacts

Eran Kozer, MD

CONTACT

972 8 9779916 erank@asaf.health.gov.il

Ehud Rosenbloom, MD