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

Ketamine

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.

Intervention / Treatment

  • Ketamine (DRUG)
    Evaluate the analgesic effectiveness of the systemic ketamine on the control of pain in the alcohol-dependent patient

Condition or Disease

  • Alcoholic Patient
  • Carcinological Surgery ORL

Phase

Study Design

Study type: INTERVENTIONAL
Status: Suspended
Study results: No Results Available
Age: 18 Years to 70 Years
Enrollment: 56 (ESTIMATED)
Funded by: Other
Allocation: Randomized
Primary Purpose: Treatment

Masking

Clinical Trial Dates

Start date: Apr 01, 2006
Primary Completion: Sep 01, 2008 ESTIMATED
Completion Date: Sep 01, 2008 ESTIMATED
Study First Posted: May 24, 2006 ESTIMATED
Results First Posted: Aug 31, 2020
Last Updated: Oct 07, 2008

Sponsors / Collaborators

Lead Sponsor: N/A
Responsible Party: N/A

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

Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: Yes

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
  • Morphine consumption at 48 hours at 48 hours
Secondary Outcomes
  • 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

More Details

NCT Number: NCT00329394
Other IDs: CHU63-008
Study URL: https://clinicaltrials.gov/study/NCT00329394
Last updated: Sep 29, 2023