Ibuprofen as a Possible Preventer of Post Bronchoscopy Fever
Recruitment status was Recruiting
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Post Bronchoscopy Fever |
Drug: ibuprofen |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Prevention |
| Official Title: | Ibuprofen as a Possible Preventer of Post Bronchoscopy Fever |
| Estimated Enrollment: | 50 |
| Arms | Assigned Interventions |
|---|---|
| Placebo Comparator: Placebo |
Drug: ibuprofen
10mg/kg syrup - single dose
|
| Active Comparator: ibuprofen |
Drug: ibuprofen
ibuprofen 10mg/kg syrup, single dose vs placebo
Drug: ibuprofen
10mg/kg syrup - single dose
|
Eligibility| Ages Eligible for Study: | up to 12 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| Contact: Leon j Joseph, MB ChB | 00 972 2 666 6292 | leonj@doctors.org.uk |
| Israel | |
| Shaare Zedek Medical Center POB 3235 | Not yet recruiting |
| Jerusalem, Israel, 91031 | |
| Contact: Leon J Joseph, MB ChB 00 972 2 666 6292 leonj@doctors.org.uk | |
| Principal Investigator: Leon J Joseph, MB ChB | |
| Shaare Zedek Medical Center | Recruiting |
| Jerusalem, Israel | |
| Contact: Leon Joseph 00 972 2 666 6292 | |
More Information
Publications:
| ClinicalTrials.gov Identifier: | NCT00954200 History of Changes |
| Other Study ID Numbers: | 26.07.09.ctil |
| Study First Received: | July 26, 2009 |
| Last Updated: | July 24, 2011 |
| Health Authority: | Israel: Ministry of Health |
Additional relevant MeSH terms:
|
Fever Body Temperature Changes Signs and Symptoms Ibuprofen Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents |
Physiological Effects of Drugs Pharmacologic Actions Anti-Inflammatory Agents Therapeutic Uses Antirheumatic Agents Cyclooxygenase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Central Nervous System Agents |
ClinicalTrials.gov processed this record on May 19, 2013