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Ibuprofen Suppositories Administration in Infants and Children

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ClinicalTrials.gov Identifier: NCT00938509
Recruitment Status : Unknown
Verified July 2009 by Soroka University Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : July 14, 2009
Last Update Posted : July 22, 2009
Sponsor:
Information provided by:
Soroka University Medical Center

Brief Summary:
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 or disease Intervention/treatment Phase
Fever Drug: ibuprofen suppositories Phase 4

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Ibuprofen Suppositories Administration for Fever Treatment in Infants and Children
Study Start Date : July 2009
Estimated Primary Completion Date : October 2009
Estimated Study Completion Date : December 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fever
U.S. FDA Resources


Intervention Details:
    Drug: ibuprofen suppositories
    5-10 mg/kg/day-suppositories


Primary Outcome Measures :
  1. Fever decrease [ Time Frame: 1 day ]


Information from the National Library of Medicine

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Ages Eligible for Study:   6 Months to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Infants and children with rectal temperature > 38.5 C

Exclusion Criteria:

  • Infants < 6 months of age

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Posted: July 14, 2009    Key Record Dates
Last Update Posted: July 22, 2009
Last Verified: July 2009

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
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action