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

NCT00329394 | Suspended Phase 3

• 1 other identifier: CHU63-008
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

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.

Conditions

Alcoholic Patient; Carcinological Surgery ORL

Keywords

Ketamine; Analgesia; Alcool-dependent; carcinological surgery

Outcome Measures

Primary Outcomes (1)

• Morphine consumption at 48 hours

  at 48 hours

Secondary Outcomes (5)

• 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

Interventions

ketamine DRUG

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

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patient alcohol-dependent having to undergo a carcinological surgery ORL with tracheotomy or tracheostomy, ASA 1-3

You may not qualify if:

• refusal of the patient
• counter-indications with the treatments,
• urgency
• the specific clinical context (final neoplasy, reanimation)
• the treatments for chronic pain containing morphinic

Sponsors & Collaborators

• University Hospital, Clermont-Ferrand: lead

Study Sites (1)

Clermont-Ferrand University Hospital

Clermont-Ferrand, 63000, France

Location

Related Publications (2)

• 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.

  PMID: 15621365 BACKGROUND

• 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.

  PMID: 15465973 BACKGROUND

MeSH Terms

Conditions

Agnosia

Interventions

Ketamine

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Nicolas Rascol, Dr

  University Hospital, Clermont-Ferrand

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: May 23, 2006
• First Posted: May 24, 2006
• Study Start: April 1, 2006
• Primary Completion: September 1, 2008
• Study Completion: September 1, 2008
• Last Updated: October 8, 2008

Record last verified: 2008-10

Locations

FR (1)