Ibuprofen as a Possible Preventer of Post Bronchoscopy Fever
Primary Purpose
Post Bronchoscopy Fever
Status
Completed
Phase
Phase 2
Locations
Israel
Study Type
Interventional
Intervention
ibuprofen
ibuprofen
Sponsored by
About this trial
This is an interventional prevention trial for Post Bronchoscopy Fever
Eligibility Criteria
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
Sites / Locations
- Shaare Zedek Medical Center POB 3235
- Shaare Zedek Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Active Comparator
Arm Label
Placebo
ibuprofen
Arm Description
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00954200
First Posted
July 26, 2009
Last Updated
October 22, 2020
Sponsor
Shaare Zedek Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT00954200
Brief Title
Ibuprofen as a Possible Preventer of Post Bronchoscopy Fever
Official Title
Ibuprofen as a Possible Preventer of Post Bronchoscopy Fever
Study Type
Interventional
2. Study Status
Record Verification Date
October 2020
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
January 2015 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Shaare Zedek Medical Center
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post Bronchoscopy Fever
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
64 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Title
ibuprofen
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
ibuprofen
Intervention Description
ibuprofen 10mg/kg syrup, single dose vs placebo
Intervention Type
Drug
Intervention Name(s)
ibuprofen
Intervention Description
10mg/kg syrup - single dose
10. Eligibility
Sex
All
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Shaare Zedek Medical Center POB 3235
City
Jerusalem
ZIP/Postal Code
91031
Country
Israel
Facility Name
Shaare Zedek Medical Center
City
Jerusalem
Country
Israel
12. IPD Sharing Statement
Citations:
PubMed Identifier
10669705
Citation
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.
Results Reference
background
PubMed Identifier
17728531
Citation
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.
Results Reference
background
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Ibuprofen as a Possible Preventer of Post Bronchoscopy Fever
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