Ibuprofen as a Possible Preventer of Post Bronchoscopy Fever
1 other identifier
interventional
64
1 country
2
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 26, 2009
CompletedFirst Posted
Study publicly available on registry
August 7, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2015
CompletedOctober 26, 2020
October 1, 2020
July 26, 2009
October 22, 2020
Conditions
Study Arms (2)
Placebo
PLACEBO COMPARATORibuprofen
ACTIVE COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- under twelve years of age
- all patients undergoing bronchoscopy and bronchoalveolar lavage
You may not qualify if:
- children with immune deficiency
- allergy to NSAIDS
- previous exacerbation of asthma due to NSAIDS
- fever on the day of the examination
- current antibiotic treatment
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Shaare Zedek Medical Center POB 3235
Jerusalem, 91031, Israel
Shaare Zedek Medical Center
Jerusalem, Israel
Related Publications (2)
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.
PMID: 10669705BACKGROUNDFonseca 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.
PMID: 17728531BACKGROUND
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
July 26, 2009
First Posted
August 7, 2009
Study Completion
January 1, 2015
Last Updated
October 26, 2020
Record last verified: 2020-10