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

• ClinicalTrials.gov Identifier: NCT00224588
• Recruitment Status: Completed
• First Posted: September 23, 2005
• Last Update Posted: April 13, 2006
• Sponsor: Assistance Publique - Hôpitaux de Paris
• 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: September 16, 2005
• First Posted Date: September 23, 2005
• Last Update Posted Date: April 13, 2006
• Study Start Date: January 2003
• Primary Completion Date: Not Provided
• Current Primary Outcome Measures (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: Same as current
• Current Secondary Outcome Measures (submitted: September 16, 2005): Analogic pain scores at rest and after coughing
• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: KETOR: Effects of Peri Operative Administration of Ketamine on Long Term Post Thoracotomy Pain
• Official Title: 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: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double; Primary Purpose: Treatment

Condition

• Ketamine
• Chronic Post Thoracotomy Pain
• Thoracotomy
• Pain
• Neuralgia

• Intervention: 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):1510-1515. doi: 10.1213/01.ANE.0000057003.91393.3C.

Recruitment Information

• Recruitment Status: Completed
• Enrollment (submitted: September 16, 2005): 80
• Original Enrollment: Same as current
• Study Completion Date: May 2005
• Primary Completion Date: Not Provided

Eligibility Criteria

Inclusion Criteria:

• Patients eligible for thoracotomy or pneumectomy

Exclusion Criteria:

-

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 80 Years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: France

Administrative Information

• NCT Number: NCT00224588
• Other Study ID Numbers: P990911; CRC99029
• Has Data Monitoring Committee: Not Provided
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Not Provided
• Original Responsible Party: Same as current
• Current Study Sponsor: Assistance Publique - Hôpitaux de Paris
• Original Study Sponsor: Same as current

Collaborators

• Direction Régionale de la Recherche Clinique D'ILE DE FRANCE
• Clinical Research Unit
• European Georges Pompidou Hospital

Investigators

• Principal Investigator: Thierry GUENOUN, MD; Assistance Publique - Hôpitaux de Paris

• PRS Account: Assistance Publique - Hôpitaux de Paris
• Verification Date: September 2005