Ibuprofen Suppositories Administration in Infants and Children

This study is not yet open for participant recruitment.

Verified by Soroka University Medical Center, July 2009

First Received: July 13, 2009 Last Updated: July 21, 2009 History of Changes

Sponsor:	Soroka University Medical Center
Information provided by:	Soroka University Medical Center
ClinicalTrials.gov Identifier:	NCT00938509

Purpose

The study will evaluate the efficacy of Ibuprofen administered as suppositories in the treatment of fever in infants and children. Ibuprofen as suppositories is not yet registered in Israel, although widely used in Europe.

Condition	Intervention	Phase
Fever	Drug: ibuprofen suppositories	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	Ibuprofen Suppositories Administration for Fever Treatment in Infants and Children

Resource links provided by NLM:

MedlinePlus related topics: Fever

Drug Information available for: Ibuprofen

U.S. FDA Resources

Further study details as provided by Soroka University Medical Center:

Primary Outcome Measures:

Fever decrease [ Time Frame: 1 day ] [ Designated as safety issue: No ]

Estimated Enrollment:	100
Study Start Date:	July 2009
Estimated Study Completion Date:	December 2009
Estimated Primary Completion Date:	October 2009 (Final data collection date for primary outcome measure)

Intervention Details:

5-10 mg/kg/day-suppositories

Detailed Description:

The drug will be used in 100 consecutive infants and children admitted with fever at the pediatric ER of the Soroka Medical Center. The information on the drug efficacy will be collected in appropriate parental questionnaires.

Eligibility

Ages Eligible for Study:	6 Months to 12 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Infants and children with rectal temperature > 38.5 C

Exclusion Criteria:

Infants < 6 months of age

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00938509

Contacts

Contact: EUGENE LEIBOVITZ, MD

972-8-6244065

eugenel@bgu.ac.il

Locations

Israel
pediatric emergency room, SOROKA MEDICAL CENTER
BEER SHEVA, Israel
pediatric emergency room, SOROKA MEDICAL CENTER
BEER SHEVA, Israel

Sponsors and Collaborators

Soroka University Medical Center

More Information

No publications provided

Responsible Party:	SOROKA UNIVERSITY MEDICAL CENTER ( PROF EUGENE LEIBOVITZ, DIRECTOR, DEPARTMENT OF PEDIATRIC EMERGENCY MEDICINE )
Study ID Numbers:	sor477208ctil
Study First Received:	July 13, 2009
Last Updated:	July 21, 2009
ClinicalTrials.gov Identifier:	NCT00938509 History of Changes
Health Authority:	Israel: Ministry of Health

Keywords provided by Soroka University Medical Center:

IBUPROFEN
CHILDREN
FEVER

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Ibuprofen
Molecular Mechanisms of Pharmacological Action
Cyclooxygenase Inhibitors
Physiological Effects of Drugs
Enzyme Inhibitors
Body Temperature Changes
Pharmacologic Actions
Fever

Signs and Symptoms
Analgesics, Non-Narcotic
Sensory System Agents
Therapeutic Uses
Anti-Inflammatory Agents, Non-Steroidal
Analgesics
Peripheral Nervous System Agents
Antirheumatic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on February 08, 2010