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Ketamine Associated With Morphine PCA After Total Hip Arthroplasty (KETAMINE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00797264
Recruitment Status : Completed
First Posted : November 25, 2008
Last Update Posted : April 11, 2013
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Tracking Information
First Submitted Date  ICMJE November 24, 2008
First Posted Date  ICMJE November 25, 2008
Last Update Posted Date April 11, 2013
Study Start Date  ICMJE November 2008
Actual Primary Completion Date October 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 24, 2008)
Morphine consumption in PACU and in hospitalisation room [ Time Frame: at 24 and 48 hours ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 24, 2008)
  • Postoperative Visual Analogic Score of pain [ Time Frame: in Recovery Room, at 24 and 48 hours, in the ward ]
  • Postoperative Measure of mechanical hyperalgesia by Von Frey filament device [ Time Frame: 24 and 48 hours in the ward ]
  • Postoperative measure Ketamine and Nor-Ketamine blood levels [ Time Frame: at 24 and 48 hours in the ward ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Ketamine Associated With Morphine PCA After Total Hip Arthroplasty
Official Title  ICMJE Impact of the Route of Administration of Ketamine Associated With Morphine PCA on Analgesia After Total Hip Arthroplasty
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.

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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Arthroplasty, Replacement, Hip
Intervention  ICMJE
  • Drug: Ketamine-Morphine
    Ketamine bolus preoperative and syringe pump peroperative, and morphine postoperative (PCA)
    Other Name: Ketamine pre and per operative, and morphine postoperative
  • Drug: Morphine
    Bolus preoperative of NaCl and syringe pump peroperative of NaCl, and morphine postoperative (PCA)
  • Drug: Postoperative PCA of Ketamine and morphine
    Bolus preoperative of NaCl and syringe pump peroperative of Ketamine, and morphine postoperative (PCA)
    Other Name: Ketamine Morphine
Study Arms  ICMJE
  • Experimental: A
    Ketamine pre and per operative, and morphine postoperative
    Intervention: Drug: Ketamine-Morphine
  • Active Comparator: B
    NaCl pre and per operative, and morphine postoperative
    Intervention: Drug: Morphine
  • Experimental: C
    Ketamine and morphine postoperative
    Intervention: Drug: Postoperative PCA of Ketamine and morphine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 10, 2013)
18
Original Estimated Enrollment  ICMJE
 (submitted: November 24, 2008)
100
Actual Study Completion Date  ICMJE October 2010
Actual Primary Completion Date October 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • total hip arthroplasty

Exclusion Criteria:

  • pre operative opioid administration
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00797264
Other Study ID Numbers  ICMJE P060402
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Assistance Publique - Hôpitaux de Paris
Original Responsible Party Yannick Vacher, Department Clinical Research of Developpement
Current Study Sponsor  ICMJE Assistance Publique - Hôpitaux de Paris
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Philippe SITBON, MD Assistance Publique - Hôpitaux de Paris Hôpital Bicêtre
PRS Account Assistance Publique - Hôpitaux de Paris
Verification Date April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP