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KETAMINE: Ketamine Associated With Morphine PCA After Total Hip Arthroplasty

Sponsor
Assistance Publique - Hôpitaux de Paris (Other)
Overall Status
Completed
CT.gov ID
NCT00797264
Collaborator
(none)
18
Enrollment
1
Location
3
Arms
23
Duration (Months)
0.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Ketamine (an analgesic drug often associated with morphine in the treatment of Opioid Induced Hyperalgesia) is often mixed in Morphine PCA syringe. We make the hypothesis that ketamine administrated separately via a continuous infusion, could induced a better analgesic effect.

We will perform a randomised double blind study to determine the best infusion mode of intravenous ketamine, associated with morphine in PCA syringe or alone in continuous infusion.

Condition or Disease Intervention/Treatment Phase
N/A

Detailed Description

Double blind study to determine the best infusion mode of intravenous ketamine, associated with morphine in PCA syringe or alone in continuous infusion

Study Design

Study Type:
Interventional
Actual Enrollment :
18 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Investigator)
Primary Purpose:
Treatment
Official Title:
Impact of the Route of Administration of Ketamine Associated With Morphine PCA on Analgesia After Total Hip Arthroplasty
Study Start Date :
Nov 1, 2008
Actual Primary Completion Date :
Oct 1, 2010
Actual Study Completion Date :
Oct 1, 2010

Arms and Interventions

Arm Intervention/Treatment
Experimental: A

Ketamine pre and per operative, and morphine postoperative

Drug: Ketamine-Morphine
Ketamine bolus preoperative and syringe pump peroperative, and morphine postoperative (PCA)
Other Names:
  • Ketamine pre and per operative, and morphine postoperative

    		•
    Active Comparator: B

    NaCl pre and per operative, and morphine postoperative

    Drug: Morphine
    Bolus preoperative of NaCl and syringe pump peroperative of NaCl, and morphine postoperative (PCA)
    Experimental: C

    Ketamine and morphine postoperative

    Drug: Postoperative PCA of Ketamine and morphine
    Bolus preoperative of NaCl and syringe pump peroperative of Ketamine, and morphine postoperative (PCA)
    Other Names:
  • Ketamine Morphine

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Morphine consumption in PACU and in hospitalisation room [at 24 and 48 hours]

    Secondary Outcome Measures

    1. Postoperative Visual Analogic Score of pain [in Recovery Room, at 24 and 48 hours, in the ward]

    2. Postoperative Measure of mechanical hyperalgesia by Von Frey filament device [24 and 48 hours in the ward]

    3. Postoperative measure Ketamine and Nor-Ketamine blood levels [at 24 and 48 hours in the ward]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • total hip arthroplasty
    Exclusion Criteria:
    • pre operative opioid administration

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Service d'anesthesie-reanimation - Hôpital Bicêtre Le Kremlin Bicêtre France 94270

    Sponsors and Collaborators

    • Assistance Publique - Hôpitaux de Paris

    Investigators

    • Principal Investigator: Philippe SITBON, MD, Assistance Publique - Hôpitaux de Paris Hôpital Bicêtre

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Assistance Publique - Hôpitaux de Paris
    ClinicalTrials.gov Identifier:
    NCT00797264
    Other Study ID Numbers:
    • P060402
    First Posted:
    Nov 25, 2008
    Last Update Posted:
    Apr 11, 2013
    Last Verified:
    Apr 1, 2013
    Keywords provided by Assistance Publique - Hôpitaux de Paris
    Ketamine
    Morphine
    PCA
    Hyperalgesia
    Nor-ketamine
    Additional relevant MeSH terms:
    Ketamine
    Morphine

    Study Results

    No Results Posted as of Apr 11, 2013