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

Fever Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00729976
• Other study ID #: 091/08
• Status: Recruiting
• Phase: Phase 4
• First received: August 6, 2008
• Last updated: April 4, 2011
• Start date: September 2008
• Est. completion date: June 2011

Study information

• Verified date: March 2010
• Source: Assaf-Harofeh Medical Center
• Contact: Eran Kozer, MD
• Phone: 972 8 9779916
• Email: erank[@]asaf.health.gov.il
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: June 2011
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 3 Months to 5 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Fever

Intervention

Drug:
• Ibuprofen suppository
5-10mg/Kg of ibuprofen
• Ibuprofen Suspension
5-10mg/Kg

Locations

Country	Name	City	State
Israel	Assaf Harofeh Medical Center	Zerifin

Sponsors (1)

Lead Sponsor	Collaborator
Assaf-Harofeh Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximal change in temperature during the 4-hour period after enrollment.		4 hours	No
Secondary	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	No