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Sponsored by: |
Shaare Zedek Medical Center |
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Information provided by: | Shaare Zedek Medical Center |
ClinicalTrials.gov Identifier: | NCT00954200 |
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 |
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Post Bronchoscopy Fever |
Drug: ibuprofen Drug: placebo |
Phase II |
Study Type: | Interventional |
Official Title: | Ibuprofen as a Possible Preventer of Post Bronchoscopy Fever |
Arms | Assigned Interventions |
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Placebo: Placebo Comparator | Drug: placebo |
ibuprofen: Active Comparator |
Drug: ibuprofen
ibuprofen 10mg/kg syrup, single dose vs placebo
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Ages Eligible for Study: | up to 12 Years |
Genders Eligible for Study: | Both |
Inclusion Criteria:
Exclusion Criteria:
Contact: Leon j Joseph, MB ChB | 00 972 2 666 6292 | leonj@doctors.org.uk |
Israel | |
Shaare Zedek Medical Center POB 3235 | |
Jerusalem, Israel, 91031 |
Study ID Numbers: | 26.07.09.ctil |
Study First Received: | July 26, 2009 |
Last Updated: | August 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00954200 History of Changes |
Health Authority: | Israel: Ministry of Health |
Anti-Inflammatory Agents Fever Signs and Symptoms Ibuprofen Analgesics, Non-Narcotic |
Cyclooxygenase Inhibitors Anti-Inflammatory Agents, Non-Steroidal Peripheral Nervous System Agents Analgesics Antirheumatic Agents |
Anti-Inflammatory Agents Ibuprofen Molecular Mechanisms of Pharmacological Action Cyclooxygenase Inhibitors Physiological Effects of Drugs Enzyme Inhibitors Body Temperature Changes Pharmacologic Actions Fever |
Signs and Symptoms Analgesics, Non-Narcotic Sensory System Agents Therapeutic Uses Anti-Inflammatory Agents, Non-Steroidal Analgesics Peripheral Nervous System Agents Antirheumatic Agents Central Nervous System Agents |