Post Bronchoscopy Fever Clinical Trial
Official title:
Ibuprofen as a Possible Preventer of Post Bronchoscopy Fever
| NCT number | NCT00954200 |
| Other study ID # | 26.07.09.ctil |
| Secondary ID | |
| Status | Completed |
| Phase | Phase 2 |
| First received | |
| Last updated | |
| Est. completion date | January 2015 |
| Verified date | October 2020 |
| Source | Shaare Zedek Medical Center |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 64 |
| Est. completion date | January 2015 |
| Est. primary completion date | |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | N/A to 12 Years |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| Israel | Shaare Zedek Medical Center | Jerusalem | |
| Israel | Shaare Zedek Medical Center POB 3235 | Jerusalem |
| Lead Sponsor | Collaborator |
|---|---|
| Shaare Zedek Medical Center |
Israel,
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. Epub 2007 Aug 29. — View 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. — View Citation