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

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

Tracking Information

• First Submitted Date: May 23, 2006
• First Posted Date: May 24, 2006
• Last Update Posted Date: October 8, 2008
• Study Start Date: April 2006
• Estimated Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: October 7, 2008): Morphine consumption at 48 hours [ Time Frame: at 48 hours ]
• Original Primary Outcome Measures (submitted: May 23, 2006): Morphine consumption at 48 hours

Current Secondary Outcome Measures (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 (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: Systemic Ketamine for the Improvement of Post-Operative Analgesia at the Alcohol-Dependent Patient
• 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.
• 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: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Single Group Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Treatment

Condition

• Alcoholic Patient
• Carcinological Surgery ORL

Intervention

Drug: ketamine

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

• Study Arms: Not Provided

Publications *

• Elia N, Tramèr 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.

Recruitment Information

• Recruitment Status: Suspended
• Estimated Enrollment (submitted: May 23, 2006): 56
• Original Enrollment: Same as current
• Estimated Study Completion Date: September 2008
• Estimated Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 70 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: France

Administrative Information

• NCT Number: NCT00329394
• Other Study ID Numbers: CHU63-008
• Has Data Monitoring Committee: Not Provided
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Dr Nicolas RASCOL, CHU Clermont-Ferrand
• Original Responsible Party: Not Provided
• Current Study Sponsor: University Hospital, Clermont-Ferrand
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Nicolas Rascol, Dr; University Hospital, Clermont-Ferrand

• PRS Account: University Hospital, Clermont-Ferrand
• Verification Date: October 2008