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

Information source: Assaf-Harofeh Medical Center
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Fever

Intervention: Ibuprofen suppository (Drug); Ibuprofen Suspension (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: Assaf-Harofeh Medical Center

Overall contact:
Eran Kozer, MD, Phone: 972 8 9779916, Email: erank@asaf.health.gov.il


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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

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

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.


Minimum age: 3 Months. Maximum age: 5 Years. Gender(s): Both.


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

Locations and Contacts

Eran Kozer, MD, Phone: 972 8 9779916, Email: erank@asaf.health.gov.il

Assaf Harofeh Medical Center, Zerifin 70300, Israel; Recruiting
Eran Kozer, MD, Phone: 97289779916, Email: erank@asaf.health.gov.il
Additional Information

Starting date: September 2008
Last updated: April 4, 2011

Page last updated: August 23, 2015

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