Ibuprofen Suppositories Administration in Infants and Children

The recruitment status of this study is unknown because the information has not been verified recently.

Verified July 2009 by Soroka University Medical Center. Recruitment status was Not yet recruiting

First Received on July 13, 2009. Last Updated on 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:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
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	Not yet recruiting
Beer Sheva, Israel
pediatric emergency room, SOROKA MEDICAL CENTER	Completed
Beer Sheva, Israel

Sponsors and Collaborators

Soroka University Medical Center

More Information

No publications provided

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

Keywords provided by Soroka University Medical Center:

IBUPROFEN
CHILDREN
FEVER

Additional relevant MeSH terms:

Fever
Body Temperature Changes
Signs and Symptoms
Ibuprofen
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents

Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Central Nervous System Agents

ClinicalTrials.gov processed this record on February 09, 2012