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

Phase 3

Suspended

• Conditions: Alcoholic Patient; Carcinological Surgery ORL

• Registration Number: NCT00329394
• Lead Sponsor: University Hospital, Clermont-Ferrand

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 Timeline

• Study Start: 2006-04
• Study First Submitted: 2006-05-23
• Study First Submitted QC: 2006-05-23
• Study First Posted: 2006-05-24
• Primary Completion: 2008-09
• Study Completion: 2008-09
• Status Verified: 2008-10
• Last Update Submitted: 2008-10-07
• Last Update Posted: 2008-10-08

Recruitment & Eligibility

• Status: SUSPENDED
• Sex: All
• Target Recruitment: 56

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Morphine consumption at 48 hours	at 48 hours

Secondary Outcome Measures

Name	Time	Method
pain	pain
the ground (dependence with alcohol)	dependence with alcohol
the first request analgesic	the first request analgesic
the tolerance and the signs psychic (syndrome of weaning...)	the tolerance and the signs psychic
and the satisfaction of the patient	the satisfaction of the patient

Trial Locations

Locations (1)

Clermont-Ferrand University Hospital; 🇫🇷 Clermont-Ferrand, France