Ibuprofen as a Possible Preventer of Post Bronchoscopy Fever

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00954200
Recruitment Status : Unknown
Verified July 2009 by Shaare Zedek Medical Center.
Recruitment status was:  Recruiting
First Posted : August 7, 2009
Last Update Posted : July 26, 2011
Information provided by:
Shaare Zedek Medical Center

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.

Condition or disease Intervention/treatment Phase
Post Bronchoscopy Fever Drug: ibuprofen Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Ibuprofen as a Possible Preventer of Post Bronchoscopy Fever

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fever
U.S. FDA Resources

Arm Intervention/treatment
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

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 12 Years   (Child)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00954200

Contact: Leon j Joseph, MB ChB 00 972 2 666 6292

Shaare Zedek Medical Center POB 3235 Not yet recruiting
Jerusalem, Israel, 91031
Contact: Leon J Joseph, MB ChB    00 972 2 666 6292   
Principal Investigator: Leon J Joseph, MB ChB         
Shaare Zedek Medical Center Recruiting
Jerusalem, Israel
Contact: Leon Joseph    00 972 2 666 6292      
Sponsors and Collaborators
Shaare Zedek Medical Center

Publications: Identifier: NCT00954200     History of Changes
Other Study ID Numbers: 26.07.09.ctil
First Posted: August 7, 2009    Key Record Dates
Last Update Posted: July 26, 2011
Last Verified: July 2009

Additional relevant MeSH terms:
Body Temperature Changes
Signs and Symptoms
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action