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

Study of the Efficacity of the Systemic Ketamine for the Improvement of Post-Operative Analgesia After ORL Carcinological Surgery at the Alcohol-Dependent Patient.

Status
Suspended
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00329394
Enrollment
56
Registered
2006-05-24
Start date
2006-04-30
Completion date
2008-09-30
Last updated
2008-10-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alcoholic Patient, Carcinological Surgery ORL

Keywords

Ketamine, Analgesia, Alcool-dependent, carcinological surgery

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.

Interventions

DRUGketamine

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

Sponsors

University Hospital, Clermont-Ferrand
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Morphine consumption at 48 hoursat 48 hours

Secondary

MeasureTime frame
painpain
the ground (dependence with alcohol)dependence with alcohol
the first request analgesicthe first request analgesic
the tolerance and the signs psychic (syndrome of weaning...)the tolerance and the signs psychic
and the satisfaction of the patientthe satisfaction of the patient

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026