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Ibuprofen Suppositories Administration in Infants and Children

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified July 2009 by Soroka University Medical Center.
Recruitment status was:  Not yet recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00938509
First Posted: July 14, 2009
Last Update Posted: July 22, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Soroka University Medical Center
  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 4

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Soroka University Medical Center:

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

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:
    Drug: ibuprofen suppositories
    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

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
  Contacts and Locations
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
  More Information

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 Submitted: July 13, 2009
First Posted: July 14, 2009
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