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

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ClinicalTrials.gov Identifier: NCT00329394
Recruitment Status : Suspended
First Posted : May 24, 2006
Last Update Posted : October 8, 2008
Sponsor:
Information provided by:
University Hospital, Clermont-Ferrand

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
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 Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures 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  ICMJE 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  ICMJE Not Provided
Publications *

*   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  ICMJE 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  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE 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  ICMJE 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