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SuspendedPhase 3

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

NCT00329394 · University Hospital, Clermont-Ferrand

Closed to entry
Status
Not accepting participants
Phase 3
Phase
56
Target enrolment
1
Study sites
Outside the US

What it is testing

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.

Summary as written by the trial’s own sponsor and published on ClinicalTrials.gov API v2. It is the sponsor’s description, reproduced unedited, not an assessment by this site.

What counts as success

Primary outcome measures

  • Morphine consumption at 48 hours

    Measured over at 48 hours

A trial succeeds or fails on its primary outcome, declared in advance. Everything else it reports is secondary by definition.

Who can take part

Eligibility, as published

18 Years to 70 Years
Ages
All
Sex
Not accepted
Healthy volunteers
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

Where

1 study site

FacilityCityRegionCountry
Clermont-Ferrand University HospitalClermont-FerrandFrance

On the registry

Contact the trial directly

This site does not enrol anyone and is not involved in this trial. To ask about taking part, use the sponsor’s own contact details on the official registry record, which is also where the most current version of everything above lives.

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NCT00329394 on ClinicalTrials.gov →

Last updated in the registry 2008-10-08. Registry records change; this page reflects the data build of 2026-08-25.

Related

Where this trial sits