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KETOR: Effects of Peri Operative Administration of Ketamine on Long Term Post Thoracotomy Pain

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.
 
ClinicalTrials.gov Identifier: NCT00224588
Recruitment Status : Completed
First Posted : September 23, 2005
Last Update Posted : April 13, 2006
Sponsor:
Collaborators:
Direction Régionale de la Recherche Clinique D'ILE DE FRANCE
Clinical Research Unit
European Georges Pompidou Hospital
Information provided by:
Assistance Publique - Hôpitaux de Paris

Tracking Information
First Submitted Date  ICMJE September 16, 2005
First Posted Date  ICMJE September 23, 2005
Last Update Posted Date April 13, 2006
Study Start Date  ICMJE January 2003
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: September 16, 2005)
Long term (2 months) post thoracotomy pain was assessed using a french equivalent of the Mc Gill Pain score and pain area measurements in both groups
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 16, 2005)
Analogic pain scores at rest and after coughing
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE KETOR: Effects of Peri Operative Administration of Ketamine on Long Term Post Thoracotomy Pain
Official Title  ICMJE Effects of Peri Operative Administration of Ketamine on Long Term Post Thoracotomy Pain
Brief Summary We assessed the effects of the N Methyl aspartate receptor antagonist Ketamine on long-term post thoracotomy pain. We hypothesized that ketamine could prevent supersensitization of the central nervous system involved in this chronic neuropathic pain.
Detailed Description In this clinical, randomized prospective study, peri operative administration of ketamine was compared to placebo on long term post thoracotomy pain after a 2 months follow up period.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Condition  ICMJE
  • Ketamine
  • Chronic Post Thoracotomy Pain
  • Thoracotomy
  • Pain
  • Neuralgia
Intervention  ICMJE Drug: Ketamine (or placebo : isotonic saline solution)
Study Arms  ICMJE Not Provided
Publications * Frappier J, Guenoun T, Journois D, Philippe H, Aka E, Cadi P, Silleran-Chassany J, Safran D. Airway management using the intubating laryngeal mask airway for the morbidly obese patient. Anesth Analg. 2003 May;96(5):1510-1515. doi: 10.1213/01.ANE.0000057003.91393.3C.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE
 (submitted: September 16, 2005)
80
Original Enrollment  ICMJE Same as current
Study Completion Date  ICMJE May 2005
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patients eligible for thoracotomy or pneumectomy

Exclusion Criteria:

-

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 80 Years and older   (Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00224588
Other Study ID Numbers  ICMJE P990911
CRC99029
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Not Provided
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Assistance Publique - Hôpitaux de Paris
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE
  • Direction Régionale de la Recherche Clinique D'ILE DE FRANCE
  • Clinical Research Unit
  • European Georges Pompidou Hospital
Investigators  ICMJE
Principal Investigator: Thierry GUENOUN, MD Assistance Publique - Hôpitaux de Paris
PRS Account Assistance Publique - Hôpitaux de Paris
Verification Date September 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP