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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00797264
First Posted: November 25, 2008
Last Update Posted: April 11, 2013
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.
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
  Purpose

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 Intervention
Arthroplasty, Replacement, Hip Drug: Ketamine-Morphine Drug: Morphine Drug: Postoperative PCA of Ketamine and morphine

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • Morphine consumption in PACU and in hospitalisation room [ Time Frame: at 24 and 48 hours ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 18
Study Start Date: November 2008
Study Completion Date: October 2010
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: Ketamine Morphine

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
  Eligibility

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • total hip arthroplasty

Exclusion Criteria:

  • pre operative opioid administration
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00797264


Locations
France
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
  More Information

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT00797264     History of Changes
Other Study ID Numbers: P060402
First Submitted: November 24, 2008
First Posted: November 25, 2008
Last Update Posted: April 11, 2013
Last Verified: April 2013

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Ketamine
Morphine
PCA
Hyperalgesia
Nor-ketamine

Additional relevant MeSH terms:
Morphine
Ketamine
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action