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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:
ClinicalTrials.gov Identifier:
NCT00329394
First Posted: May 24, 2006
Last Update Posted: October 8, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
University Hospital, Clermont-Ferrand
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, 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:


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

Primary Outcome Measures:
  • Morphine consumption at 48 hours [ Time Frame: at 48 hours ]

Secondary Outcome Measures:
  • 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 ]

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:
    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

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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:
Responsible Party: Dr Nicolas RASCOL, CHU Clermont-Ferrand
ClinicalTrials.gov Identifier: NCT00329394     History of Changes
Other Study ID Numbers: CHU63-008
First Submitted: May 23, 2006
First Posted: May 24, 2006
Last Update Posted: October 8, 2008
Last Verified: October 2008

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

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