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

This study is currently recruiting participants.
Verified by University Hospital, Clermont-Ferrand, November 2007

Sponsored by: 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

ChemIDplus related topics:   Ketamine    Ketamine hydrochloride    Ethanol   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Double-Blind, Placebo Control, Single Group Assignment, Efficacy Study
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.

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

Primary Outcome Measures:
  • Morphine consumption at 48 hours

Secondary Outcome Measures:
  • 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

Estimated Enrollment:   56
Study Start Date:   April 2006
Estimated Study Completion Date:   June 2007

Intervention Details:
    Drug: ketamine
    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

Contacts
Contact: Nicolas Rascol, Dr     (33)04 73 750 750    

Locations
France
Clermont-Ferrand University Hospital     Recruiting
      Clermont-Ferrand, France, 63000
      Contact: Nicolas Rascol, Doctor     (33) 04 73 750 750        

Sponsors and Collaborators
University Hospital, Clermont-Ferrand

Investigators
Principal Investigator:     Nicolas Rascol, Dr     University Hospital, Clermont-Ferrand    
  More Information

Publications:

Study ID Numbers:   CHU63-008
First Received:   May 23, 2006
Last Updated:   November 30, 2007
ClinicalTrials.gov Identifier:   NCT00329394
Health Authority:   France: Ministry of Health

Keywords provided by University Hospital, Clermont-Ferrand:
Ketamine  
Analgesia  
Alcool-dependent  
carcinological surgery  

Study placed in the following topic categories:
Excitatory Amino Acids
Ketamine
Ethanol

Additional relevant MeSH terms:
Anesthetics, Intravenous
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Anesthetics
Central Nervous System Depressants
Excitatory Amino Acid Agents
Anesthetics, Dissociative
Pharmacologic Actions
Sensory System Agents
Anesthetics, General
Therapeutic Uses
Peripheral Nervous System Agents
Analgesics
Central Nervous System Agents
Excitatory Amino Acid Antagonists

ClinicalTrials.gov processed this record on August 20, 2008




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