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Oral Versus Rectal Ibuprofen for Fever in Young Children - a Randomized Control Study.

Primary Purpose

Fever

Status
Unknown status
Phase
Phase 4
Locations
Israel
Study Type
Interventional
Intervention
Ibuprofen suppository
Ibuprofen Suspension
Sponsored by
Assaf-Harofeh Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fever focused on measuring Ibuprofen, Suppository, febrile children

Eligibility Criteria

3 Months - 5 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Age: 3 mo- 4 years

  • Weight 6 - 18 kg
  • Rectal temperature > 38.50

Exclusion Criteria:

  • Treatment with acetaminophen in the last 4 hours
  • Treatment with Ibuprofen in the last 6 hours
  • Unable to take oral or rectal medications
  • Hypersensitivity to ibuprofen
  • Renal failure
  • Liver disease
  • Rectal temperature can't be measured (due to anatomical or medical problem)
  • Informed consent could not be granted

Sites / Locations

  • Assaf Harofeh Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

1

2

Arm Description

Ibuprofen Suppository

Ibuprofen suspension

Outcomes

Primary Outcome Measures

Maximal change in temperature during the 4-hour period after enrollment.

Secondary Outcome Measures

Proportion of patients with a drop of at least 1°C and 2°C in mean temperature at 4h. Decrement in fever at each time point, and the area under the temperature (versus time) curve. Proportion of patients with temperature < 38 at 4 hours.

Full Information

First Posted
August 6, 2008
Last Updated
April 4, 2011
Sponsor
Assaf-Harofeh Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT00729976
Brief Title
Oral Versus Rectal Ibuprofen for Fever in Young Children - a Randomized Control Study.
Official Title
Oral Versus Rectal Ibuprofen for Fever in Young Children - a Randomized Control Study.
Study Type
Interventional

2. Study Status

Record Verification Date
March 2010
Overall Recruitment Status
Unknown status
Study Start Date
September 2008 (undefined)
Primary Completion Date
December 2010 (Anticipated)
Study Completion Date
June 2011 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Assaf-Harofeh Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Fever is one of the most common symptoms in pediatrics and one of the most common reasons for visits in pediatricians' office and pediatric emergency departments. Many parents consider fever to be the most terrifying symptom. Ibuprofen is an effective and safe treatment for febrile children. Until recently ibuprofen was available only in tablets suspension and as a liquid gel. All these dosage form are administered orally. Rectal suppositories are often essential for treating febrile children who cannot take medications by mouth (e.g vomiting). In the current study we aim to compare the effect on fever of ibuprofen given as suspension with ibuprofen suppositories.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fever
Keywords
Ibuprofen, Suppository, febrile children

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Ibuprofen Suppository
Arm Title
2
Arm Type
Active Comparator
Arm Description
Ibuprofen suspension
Intervention Type
Drug
Intervention Name(s)
Ibuprofen suppository
Intervention Description
5-10mg/Kg of ibuprofen
Intervention Type
Drug
Intervention Name(s)
Ibuprofen Suspension
Intervention Description
5-10mg/Kg
Primary Outcome Measure Information:
Title
Maximal change in temperature during the 4-hour period after enrollment.
Time Frame
4 hours
Secondary Outcome Measure Information:
Title
Proportion of patients with a drop of at least 1°C and 2°C in mean temperature at 4h. Decrement in fever at each time point, and the area under the temperature (versus time) curve. Proportion of patients with temperature < 38 at 4 hours.
Time Frame
4 h

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Months
Maximum Age & Unit of Time
5 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age: 3 mo- 4 years Weight 6 - 18 kg Rectal temperature > 38.50 Exclusion Criteria: Treatment with acetaminophen in the last 4 hours Treatment with Ibuprofen in the last 6 hours Unable to take oral or rectal medications Hypersensitivity to ibuprofen Renal failure Liver disease Rectal temperature can't be measured (due to anatomical or medical problem) Informed consent could not be granted
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Eran Kozer, MD
Phone
972 8 9779916
Email
erank@asaf.health.gov.il
First Name & Middle Initial & Last Name or Official Title & Degree
Ehud Rosenbloom, MD
Phone
972 8 9779916
Email
ehudroze@gmail.com
Facility Information:
Facility Name
Assaf Harofeh Medical Center
City
Zerifin
ZIP/Postal Code
70300
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eran Kozer, MD
Phone
97289779916
Email
erank@asaf.health.gov.il

12. IPD Sharing Statement

Learn more about this trial

Oral Versus Rectal Ibuprofen for Fever in Young Children - a Randomized Control Study.

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