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Ibuprofen as a Possible Preventer of Post Bronchoscopy Fever

NCT ID: NCT00954200

Last Updated: 2020-10-26

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

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Study Completion Date

2015-01-31

Brief Summary

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Scientific background: Bronchoscopy is a procedure commonly performed in the management of persistent respiratory illness. In the last decades this exam has become a routine and safe procedure even in children and there are few side-effects. However, one known side effect is transient fever and even high fever a few hours after the bronchoscopy. This side effect is not dangerous but very uncomfortable for the patients and it would be interesting to try to reduce this phenomena. This fever is due to a release of cytokines during the broncho-alveolar lavage procedure and not to sepsis. In a previous study a single dose of dexamethasone was shown to prevent the fever post bronchoscopy with no apparent detriment to the child. It is well known that steroids are immunosuppressive. Even though the post-bronchoscopy fever is not caused by an infection, it seems preferable to use other anti-inflammatory drugs to fight this very inconvenient side effect.

Ibuprofen (Nurofen\*) is known as an effective medication to reduce fever in infectious illnesses and is even considered as superior to paracetamol. It has no immunosuppressive effect and is usually well tolerated by children with very few side effects when taken in the normal therapeutic dose of 10mg/Kg. The investigators postulate that a dose of Nurofen prior to bronchoscopy could significantly reduce fever post bronchoscopy.

Detailed Description

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Conditions

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Post Bronchoscopy Fever

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Placebo

Group Type PLACEBO_COMPARATOR

ibuprofen

Intervention Type DRUG

10mg/kg syrup - single dose

ibuprofen

Group Type ACTIVE_COMPARATOR

ibuprofen

Intervention Type DRUG

ibuprofen 10mg/kg syrup, single dose vs placebo

ibuprofen

Intervention Type DRUG

10mg/kg syrup - single dose

Interventions

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ibuprofen

ibuprofen 10mg/kg syrup, single dose vs placebo

Intervention Type DRUG

ibuprofen

10mg/kg syrup - single dose

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* under twelve years of age
* all patients undergoing bronchoscopy and bronchoalveolar lavage

Exclusion Criteria

* children with immune deficiency
* allergy to NSAIDS
* previous exacerbation of asthma due to NSAIDS
* fever on the day of the examination
* current antibiotic treatment
Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shaare Zedek Medical Center

OTHER

Sponsor Role lead

Locations

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Shaare Zedek Medical Center POB 3235

Jerusalem, , Israel

Site Status

Shaare Zedek Medical Center

Jerusalem, , Israel

Site Status

Countries

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Israel

References

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Picard E, Schwartz S, Goldberg S, Glick T, Villa Y, Kerem E. A prospective study of fever and bacteremia after flexible fiberoptic bronchoscopy in children. Chest. 2000 Feb;117(2):573-7. doi: 10.1378/chest.117.2.573.

Reference Type BACKGROUND
PMID: 10669705 (View on PubMed)

Fonseca MT, Camargos PA, Abou Taam R, Le Bourgeois M, Scheinmann P, de Blic J. Incidence rate and factors related to post-bronchoalveolar lavage fever in children. Respiration. 2007;74(6):653-8. doi: 10.1159/000107737. Epub 2007 Aug 29.

Reference Type BACKGROUND
PMID: 17728531 (View on PubMed)

Other Identifiers

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26.07.09.ctil

Identifier Type: -

Identifier Source: org_study_id