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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:
Information provided by:
University Hospital, Clermont-Ferrand
ClinicalTrials.gov Identifier:
NCT00329394
First received: May 23, 2006
Last updated: October 7, 2008
Last verified: October 2008
History of Changes

May 23, 2006
October 7, 2008
April 2006
September 2008   (final data collection date for primary outcome measure)
Morphine consumption at 48 hours [ Time Frame: at 48 hours ] [ Designated as safety issue: Yes ]
Morphine consumption at 48 hours
Complete list of historical versions of study NCT00329394 on ClinicalTrials.gov Archive Site
  • 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 ]
  • 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
Not Provided
Not Provided
 
Systemic Ketamine for the Improvement of Post-Operative Analgesia at the Alcohol-Dependent Patient
Study of the Efficacity of the Systemic Ketamine for the Improvement of Post-Operative Analgesia After ORL Carcinological Surgery at the Alcohol-Dependent Patient.
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.
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.
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
  • Alcoholic Patient
  • Carcinological Surgery ORL
Drug: ketamine
Evaluate the analgesic effectiveness of the systemic ketamine on the control of pain in the alcohol-dependent patient
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Suspended
56
September 2008
September 2008   (final data collection date for primary outcome measure)

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
Both
18 Years to 70 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT00329394
CHU63-008
Not Provided
Not Provided
Not Provided
Dr Nicolas RASCOL, CHU Clermont-Ferrand
University Hospital, Clermont-Ferrand
Not Provided
Principal Investigator: Nicolas Rascol, Dr University Hospital, Clermont-Ferrand
University Hospital, Clermont-Ferrand
October 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP