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

Sponsor:	University Hospital, Clermont-Ferrand
Information provided by:	University Hospital, Clermont-Ferrand
ClinicalTrials.gov Identifier:	NCT00329394

Purpose

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.

Condition	Intervention	Phase
Alcoholic Patient Carcinological Surgery ORL	Drug: ketamine	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Official Title:	Study of the Efficacity of the Systemic Ketamine for the Improvement of Post-Operative Analgesia After ORL Carcinological Surgery at the Alcohol-Dependent Patient.

Resource links provided by NLM:

Drug Information available for: Ethanol Ketamine hydrochloride Ketamine

U.S. FDA Resources

Further study details as provided by University Hospital, Clermont-Ferrand:

Primary Outcome Measures:

Morphine consumption at 48 hours [ Time Frame: at 48 hours ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

pain [ Time Frame: pain ] [ Designated as safety issue: Yes ]
the ground (dependence with alcohol) [ Time Frame: dependence with alcohol ] [ Designated as safety issue: Yes ]
the first request analgesic [ Time Frame: the first request analgesic ] [ Designated as safety issue: Yes ]
the tolerance and the signs psychic (syndrome of weaning...) [ Time Frame: the tolerance and the signs psychic ] [ Designated as safety issue: Yes ]
and the satisfaction of the patient [ Time Frame: the satisfaction of the patient ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	56
Study Start Date:	April 2006
Estimated Study Completion Date:	September 2008
Estimated Primary Completion Date:	September 2008 (Final data collection date for primary outcome measure)

Intervention Details:

Evaluate the analgesic effectiveness of the systemic ketamine on the control of pain in the alcohol-dependent 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.

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00329394

Locations

France
Clermont-Ferrand University Hospital
Clermont-Ferrand, France, 63000

Sponsors and Collaborators

University Hospital, Clermont-Ferrand

Investigators

Principal Investigator:

Nicolas Rascol, Dr

University Hospital, Clermont-Ferrand

More Information

Publications:

Elia N, Tramer 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.

Responsible Party:	Dr Nicolas RASCOL, CHU Clermont-Ferrand
ClinicalTrials.gov Identifier:	NCT00329394 History of Changes
Other Study ID Numbers:	CHU63-008
Study First Received:	May 23, 2006
Last Updated:	October 7, 2008
Health Authority:	France: Ministry of Health

Keywords provided by University Hospital, Clermont-Ferrand:

Ketamine
Analgesia
Alcool-dependent
carcinological surgery

Additional relevant MeSH terms:

Ketamine
Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents

Therapeutic Uses
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Analgesics
Sensory System Agents
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on February 12, 2012