Systemic Ketamine for the Improvement of Post-Operative Analgesia at the Alcohol-Dependent Patient

Tracking Information
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; (submitted: October 7, 2008)	Morphine consumption at 48 hours [ Time Frame: at 48 hours ]
Original Primary Outcome Measures ICMJE; (submitted: May 23, 2006)	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; (submitted: October 7, 2008)	pain [ Time Frame: pain ]; the ground (dependence with alcohol) [ Time Frame: dependence with alcohol ]; the first request analgesic [ Time Frame: the first request analgesic ]; the tolerance and the signs psychic (syndrome of weaning...) [ Time Frame: the tolerance and the signs psychic ]; and the satisfaction of the patient [ Time Frame: the satisfaction of the patient ]
Original Secondary Outcome Measures ICMJE; (submitted: May 23, 2006)	pain; the ground (dependence with alcohol); the first request analgesic; the tolerance and the signs psychic (syndrom of weaning...); and the satisfaction of the patient
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
Condition ICMJE	Alcoholic Patient; Carcinological Surgery ORL
Intervention ICMJE	Drug: ketamine; Evaluate the analgesic effectiveness of the systemic ketamine on the control of pain in the alcohol-dependent patient
Study Arms	Not Provided
Publications *	Elia N, Tramèr MR. Ketamine and postoperative pain--a quantitative systematic review of randomised trials. Pain. 2005 Jan;113(1-2):61-70. Review.; Petrakis IL, Limoncelli D, Gueorguieva R, Jatlow P, Boutros NN, Trevisan L, Gelernter J, Krystal JH. Altered NMDA glutamate receptor antagonist response in individuals with a family vulnerability to alcoholism. Am J Psychiatry. 2004 Oct;161(10):1776-82.
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Suspended
Estimated Enrollment ICMJE; (submitted: May 23, 2006)	56
Original Enrollment ICMJE	Same as current
Estimated Study Completion Date	September 2008
Estimated Primary Completion Date	September 2008 (Final data collection date for primary outcome measure)
Eligibility Criteria ICMJE	Inclusion Criteria: patient alcohol-dependent having to undergo a carcinological surgery ORL with tracheotomy or tracheostomy, ASA 1-3 Exclusion Criteria: refusal of the patient; counter-indications with the treatments,; urgency; the specific clinical context (final neoplasy, reanimation); the treatments for chronic pain containing morphinic
Sex/Gender	Sexes Eligible for Study: All
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	Principal Investigator: Nicolas Rascol, Dr University Hospital, Clermont-Ferrand
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