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Ibuprofen as a Possible Preventer of Post Bronchoscopy Fever
This study is not yet open for participant recruitment.
Verified by Shaare Zedek Medical Center, July 2009
First Received: July 26, 2009   Last Updated: August 6, 2009   History of Changes
Sponsored by: Shaare Zedek Medical Center
Information provided by: Shaare Zedek Medical Center
ClinicalTrials.gov Identifier: NCT00954200
  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
Drug: placebo
Phase II

Study Type: Interventional
Official Title: Ibuprofen as a Possible Preventer of Post Bronchoscopy Fever

Resource links provided by NLM:


Further study details as provided by Shaare Zedek Medical Center:

Arms Assigned Interventions
Placebo: Placebo Comparator Drug: placebo
ibuprofen: Active Comparator Drug: ibuprofen
ibuprofen 10mg/kg syrup, single dose vs placebo

  Eligibility

Ages Eligible for Study:   up to 12 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00954200

Contacts
Contact: Leon j Joseph, MB ChB 00 972 2 666 6292 leonj@doctors.org.uk

Locations
Israel
Shaare Zedek Medical Center POB 3235
Jerusalem, Israel, 91031
Sponsors and Collaborators
Shaare Zedek Medical Center
  More Information

Publications:
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

Study placed in the following topic categories:
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

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on September 11, 2009