Clinical trial NCT00329394: 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.
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: PHASE3
Conditions: Alcoholic Patient
Carcinological Surgery ORL
Keywords: Ketamine
Analgesia
Alcool-dependent
carcinological surgery
Lead sponsor: University Hospital, Clermont-Ferrand
Sponsor class: OTHER
First posted: 2006-05-24
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Morphine consumption at 48 hours
timeFrame: at 48 hours
Secondary outcomes:
measure: pain
timeFrame: pain
measure: the ground (dependence with alcohol)
timeFrame: dependence with alcohol
measure: the first request analgesic
timeFrame: the first request analgesic
measure: the tolerance and the signs psychic (syndrome of weaning...)
timeFrame: the tolerance and the signs psychic
measure: and the satisfaction of the patient
timeFrame: the satisfaction of the patient
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: Clermont-Ferrand University Hospital
Study officials:
affiliation: University Hospital, Clermont-Ferrand
name: Nicolas Rascol, Dr
role: PRINCIPAL_INVESTIGATOR
References:
citation: Elia N, Tramer MR. Ketamine and postoperative pain--a quantitative systematic review of randomised trials. Pain. 2005 Jan;113(1-2):61-70. doi: 10.1016/j.pain.2004.09.036.
citation: 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. doi: 10.1176/ajp.161.10.1776.