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

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	Complete list of historical versions of study NCT00224588 on ClinicalTrials.gov Archive Site
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 Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	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	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	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):1510-5, table of contents.
* 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	May 2005
Primary Completion Date	Not Provided
Eligibility Criteria ICMJE	Inclusion Criteria: Patients eligible for thoracotomy or pneumectomy Exclusion Criteria:
Sex/Gender	Sexes Eligible for Study: All
Ages	80 Years and older (Senior)
Accepts Healthy Volunteers	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	Not Provided
Responsible Party	Not Provided
Study Sponsor ICMJE	Assistance Publique - Hôpitaux de Paris
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