Back to resultsIbuprofen Suppositories Administration in Infants and Children
Primary Purpose
Fever
Status
Unknown status
Phase
Phase 4
Locations
Israel
Study Type
Interventional
Intervention
ibuprofen suppositories
Sponsored by
About this trial
This is an interventional treatment trial for Fever focused on measuring IBUPROFEN, CHILDREN, FEVER
Eligibility Criteria
Inclusion Criteria:
- Infants and children with rectal temperature > 38.5 C
Exclusion Criteria:
- Infants < 6 months of age
Sites / Locations
- pediatric emergency room, SOROKA MEDICAL CENTER
Outcomes
Primary Outcome Measures
Fever decrease
Secondary Outcome Measures
Full Information
NCT ID
NCT00938509
First Posted
July 13, 2009
Last Updated
July 21, 2009
Sponsor
Soroka University Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT00938509
Brief Title
Ibuprofen Suppositories Administration in Infants and Children
Official Title
Ibuprofen Suppositories Administration for Fever Treatment in Infants and Children
Study Type
Interventional
2. Study Status
Record Verification Date
July 2009
Overall Recruitment Status
Unknown status
Study Start Date
July 2009 (undefined)
Primary Completion Date
October 2009 (Anticipated)
Study Completion Date
December 2009 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Soroka University Medical Center
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fever
Keywords
IBUPROFEN, CHILDREN, FEVER
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
ibuprofen suppositories
Intervention Description
5-10 mg/kg/day-suppositories
Primary Outcome Measure Information:
Title
Fever decrease
Time Frame
1 day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Infants and children with rectal temperature > 38.5 C
Exclusion Criteria:
Infants < 6 months of age
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
EUGENE LEIBOVITZ, MD
Phone
972-8-6244065
Email
eugenel@bgu.ac.il
Facility Information:
Facility Name
pediatric emergency room, SOROKA MEDICAL CENTER
City
Beer Sheva
Country
Israel
12. IPD Sharing Statement
Learn more about this trial
Ibuprofen Suppositories Administration in Infants and Children
We'll reach out to this number within 24 hrs