Ibuprofen Suppositories Administration in Infants and Children

NCT ID: NCT00938509

Last Updated: 2009-07-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-07-31

Study Completion Date

2009-12-31

Brief Summary

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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

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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.

Conditions

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Fever

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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ibuprofen suppositories

5-10 mg/kg/day-suppositories

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Infants and children with rectal temperature \> 38.5 C

Exclusion Criteria

* Infants \< 6 months of age
Minimum Eligible Age

6 Months

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Soroka University Medical Center

OTHER

Sponsor Role lead

Responsible Party

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SOROKA UNIVERSITY MEDICAL CENTER

Locations

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pediatric emergency room, SOROKA MEDICAL CENTER

Beersheba, , Israel

Site Status

Countries

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Israel

Central Contacts

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EUGENE LEIBOVITZ, MD

Role: CONTACT

972-8-6244065

Other Identifiers

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sor477208ctil

Identifier Type: -

Identifier Source: org_study_id

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