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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT00729976
Other study ID # 091/08
Secondary ID
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


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
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