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Ibuprofen as a Possible Preventer of Post Bronchoscopy Fever

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2009 by Shaare Zedek Medical Center.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Shaare Zedek Medical Center
ClinicalTrials.gov Identifier:
NCT00954200
First received: July 26, 2009
Last updated: July 24, 2011
Last verified: July 2009
  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

Resource links provided by NLM:


Further study details as provided by Shaare Zedek Medical Center:

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
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 Recruiting
Jerusalem, Israel
Contact: Leon Joseph    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    leonj@doctors.org.uk   
Principal Investigator: Leon J Joseph, MB ChB         
Sponsors and Collaborators
Shaare Zedek Medical Center
  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
Analgesics
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Antirheumatic Agents
Central Nervous System Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 27, 2014