Back to resultsKETOR: Effects of Peri Operative Administration of Ketamine on Long Term Post Thoracotomy Pain
Primary Purpose
Ketamine, Chronic Post Thoracotomy Pain, Thoracotomy
Status
Completed
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
Ketamine (or placebo : isotonic saline solution)
Sponsored by
About this trial
This is an interventional treatment trial for Ketamine focused on measuring Ketamine, Chronic post thoracotomy pain, NMDA, Post operative
Eligibility Criteria
Inclusion Criteria: Patients eligible for thoracotomy or pneumectomy Exclusion Criteria: -
Sites / Locations
- Georges Pompidou European Hospital
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Analogic pain scores at rest and after coughing
Full Information
NCT ID
NCT00224588
First Posted
September 16, 2005
Last Updated
April 12, 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
1. Study Identification
Unique Protocol Identification Number
NCT00224588
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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2005
Overall Recruitment Status
Completed
Study Start Date
January 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
May 2005 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris
Collaborators
Direction Régionale de la Recherche Clinique D'ILE DE FRANCE, Clinical Research Unit, European Georges Pompidou Hospital
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ketamine, Chronic Post Thoracotomy Pain, Thoracotomy, Pain, Neuralgia
Keywords
Ketamine, Chronic post thoracotomy pain, NMDA, Post operative
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
80 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Ketamine (or placebo : isotonic saline solution)
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
Analogic pain scores at rest and after coughing
10. Eligibility
Sex
All
Minimum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients eligible for thoracotomy or pneumectomy
Exclusion Criteria:
-
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thierry GUENOUN, MD
Organizational Affiliation
Assistance Publique - Hôpitaux de Paris
Official's Role
Principal Investigator
Facility Information:
Facility Name
Georges Pompidou European Hospital
City
Paris
State/Province
Ile de France
ZIP/Postal Code
75015
Country
France
12. IPD Sharing Statement
Citations:
PubMed Identifier
12707159
Citation
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.
Results Reference
background
Learn more about this trial
KETOR: Effects of Peri Operative Administration of Ketamine on Long Term Post Thoracotomy Pain
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