Systemic Ketamine for the Improvement of Post-Operative Analgesia at the Alcohol-Dependent Patient
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ClinicalTrials.gov Identifier: NCT00329394 |
Recruitment Status :
Suspended
First Posted : May 24, 2006
Last Update Posted : October 8, 2008
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Sponsor:
University Hospital, Clermont-Ferrand
Information provided by:
University Hospital, Clermont-Ferrand
Tracking Information | ||||
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First Submitted Date ICMJE | May 23, 2006 | |||
First Posted Date ICMJE | May 24, 2006 | |||
Last Update Posted Date | October 8, 2008 | |||
Study Start Date ICMJE | April 2006 | |||
Estimated Primary Completion Date | September 2008 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
Morphine consumption at 48 hours [ Time Frame: at 48 hours ] | |||
Original Primary Outcome Measures ICMJE |
Morphine consumption at 48 hours | |||
Change History | ||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Pre-specified Outcome Measures | Not Provided | |||
Original Other Pre-specified Outcome Measures | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | Systemic Ketamine for the Improvement of Post-Operative Analgesia at the Alcohol-Dependent Patient | |||
Official Title ICMJE | Study of the Efficacity of the Systemic Ketamine for the Improvement of Post-Operative Analgesia After ORL Carcinological Surgery at the Alcohol-Dependent Patient. | |||
Brief Summary | The principal objective is to evaluate the analgesic effectiveness of the systemic ketamine on the control of the pain (average consumption of morphine at 48 hours) at the alcool-dependent patient, in carcinological surgery ORL. The effect coanalgesic is found for low dose of ketamine and action anti NMDA seems to have a stabilizing effect on this particular type of patient. This imbalance of the receivers, with a greater number of r-NMDA among these patients would involve it a better analgesic effectiveness and less effects dysphoric, to see an improvement on the syndrome of weaning. The secondary objectives evaluate the pain, the ground (dependence with alcohol), the first request analgesic, the tolerance and the signs psychic (syndrome of weaning...) and the satisfaction of the patient. | |||
Detailed Description | The principal objective is to evaluate the analgesic effectiveness of the systemic ketamine on the control of the pain (average consumption of morphine at 48 hours) at the alcool-dependent patient, in carcinological surgery ORL. The effect coanalgesic is found for low dose of ketamine and action anti NMDA seems to have a stabilizing effect on this particular type of patient. This imbalance of the receivers, with a greater number of r-NMDA among these patients would involve it a better analgesic effectiveness and less effects dysphoric, to see an improvement on the syndrome of weaning. The secondary objectives evaluate the pain, the ground (dependence with alcohol), the first request analgesic, the tolerance and the signs psychic (syndrome of weaning...) and the satisfaction of the patient. | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 3 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Single Group Assignment Masking: Double (Participant, Investigator) Primary Purpose: Treatment |
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Condition ICMJE |
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Intervention ICMJE | Drug: ketamine
Evaluate the analgesic effectiveness of the systemic ketamine on the control of pain in the alcohol-dependent patient
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Study Arms ICMJE | Not Provided | |||
Publications * |
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* 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 | Suspended | |||
Estimated Enrollment ICMJE |
56 | |||
Original Enrollment ICMJE | Same as current | |||
Estimated Study Completion Date ICMJE | September 2008 | |||
Estimated Primary Completion Date | September 2008 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 70 Years (Adult, 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 | NCT00329394 | |||
Other Study ID Numbers ICMJE | CHU63-008 | |||
Has Data Monitoring Committee | Not Provided | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Current Responsible Party | Dr Nicolas RASCOL, CHU Clermont-Ferrand | |||
Original Responsible Party | Not Provided | |||
Current Study Sponsor ICMJE | University Hospital, Clermont-Ferrand | |||
Original Study Sponsor ICMJE | Same as current | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | University Hospital, Clermont-Ferrand | |||
Verification Date | October 2008 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |