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Systemic Ketamine for the Improvement of Post-Operative Analgesia at the Alcohol-Dependent Patient
This study has suspended participant recruitment.
Sponsor:
University Hospital, Clermont-Ferrand
Information provided by:
University Hospital, Clermont-Ferrand
ClinicalTrials.gov Identifier:
NCT00329394
First received: May 23, 2006
Last updated: October 7, 2008
Last verified: October 2008
| Tracking Information | ||||
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| First Received Date ICMJE | May 23, 2006 | |||
| Last Updated Date | October 7, 2008 | |||
| 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 | Complete list of historical versions of study NCT00329394 on ClinicalTrials.gov Archive Site | |||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE |
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| Current Other Outcome Measures ICMJE | Not Provided | |||
| Original Other Outcome Measures ICMJE | 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 | 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 | 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 | |||
| Estimated Completion Date | 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 |
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| Ages | 18 Years to 70 Years (Adult, 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 | NCT00329394 | |||
| Other Study ID Numbers ICMJE | CHU63-008 | |||
| Has Data Monitoring Committee | Not Provided | |||
| U.S. FDA-regulated Product | Not Provided | |||
| IPD Sharing Statement | Not Provided | |||
| Responsible Party | Dr Nicolas RASCOL, CHU Clermont-Ferrand | |||
| Study Sponsor ICMJE | University Hospital, Clermont-Ferrand | |||
| Collaborators ICMJE | Not Provided | |||
| Investigators ICMJE |
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| PRS Account | University Hospital, Clermont-Ferrand | |||
| Verification Date | October 2008 | |||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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