KETOR: Effects of Peri Operative Administration of Ketamine on Long Term Post Thoracotomy Pain
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ClinicalTrials.gov Identifier: NCT00224588 |
Recruitment Status :
Completed
First Posted : September 23, 2005
Last Update Posted : April 13, 2006
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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 | ||||
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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 |
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 |
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 |
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Condition ICMJE |
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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. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Enrollment ICMJE |
80 | |||
Original Enrollment ICMJE | Same as current | |||
Study Completion Date ICMJE | May 2005 | |||
Primary Completion Date | Not Provided | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria: - |
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Sex/Gender ICMJE |
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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 |
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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 |
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Investigators ICMJE |
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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 |