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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

Study Description
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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
Arthroplasty, Replacement, Hip Drug: Ketamine-Morphine Drug: Morphine Drug: Postoperative PCA of Ketamine and morphine Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
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 : November 2008
Actual Primary Completion Date : October 2010
Actual Study Completion Date : October 2010

Resource links provided by the National Library of Medicine


Arms and Interventions
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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 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


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

Secondary Outcome Measures :
  1. Postoperative Visual Analogic Score of pain [ Time Frame: in Recovery Room, at 24 and 48 hours, in the ward ]
  2. Postoperative Measure of mechanical hyperalgesia by Von Frey filament device [ Time Frame: 24 and 48 hours in the ward ]
  3. Postoperative measure Ketamine and Nor-Ketamine blood levels [ Time Frame: at 24 and 48 hours in the ward ]

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

Inclusion Criteria:

  • total hip arthroplasty

Exclusion Criteria:

  • pre operative opioid administration
Contacts and Locations
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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
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France
Service d'anesthesie-reanimation - Hôpital Bicêtre
Le Kremlin Bicêtre, France, 94270
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
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Principal Investigator: Philippe SITBON, MD Assistance Publique - Hôpitaux de Paris Hôpital Bicêtre
More Information
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Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT00797264    
Other Study ID Numbers: P060402
First Posted: November 25, 2008    Key Record Dates
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:
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Ketamine
Morphine
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
 Anesthetics
Central Nervous System Depressants
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Analgesics, Opioid
Narcotics