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| Sponsor: | Assistance Publique - Hôpitaux de Paris |
|---|---|
| Information provided by: | Assistance Publique - Hôpitaux de Paris |
| ClinicalTrials.gov Identifier: | NCT00797264 |
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: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Active Control, Parallel Assignment, Efficacy Study |
| Official Title: | Impact of the Route of Administration of Ketamine Associated With Morphine PCA on Analgesia After Total Hip Arthroplasty |
| Estimated Enrollment: | 100 |
| Study Start Date: | November 2008 |
| Estimated Study Completion Date: | November 2010 |
| Estimated Primary Completion Date: | November 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
A: Experimental
Ketamine pre and per operative, and morphine postoperative
|
Drug: Ketamine-Morphine
Ketamine bolus preoperative and syringe pump peroperative, and morphine postoperative (PCA)
|
|
B: Active Comparator
NaCl pre and per operative, and morphine postoperative
|
Drug: Morphine
Bolus preoperative of NaCl and syringe pump peroperative of NaCl, and morphine postoperative (PCA)
|
|
C: Experimental
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)
|
Double blind study to determine the best infusion mode of intravenous ketamine, associated with morphine in PCA syringe or alone in continuous infusion
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Philippe SITBON, MD | +33(0)-1 45213447 | philippe.sitbon@bct.aphp.fr |
| France | |
| Service d'anesthesie-reanimation - Hôpital Bicêtre | Recruiting |
| Le Kremlin Bicêtre, France, 94270 | |
| Contact: Philippe SITBON, MD +33(0)-1 4521 3447 philippe.sitbon@bct.aphp.fr | |
| Principal Investigator: | Philippe SITBON, MD | Assistance Publique - Hôpitaux de Paris Hôpital Bicêtre |
More Information
| Responsible Party: | Department Clinical Research of Developpement ( Yannick Vacher ) |
| Study ID Numbers: | P060402 |
| Study First Received: | November 24, 2008 |
| Last Updated: | November 30, 2009 |
| ClinicalTrials.gov Identifier: | NCT00797264 History of Changes |
| Health Authority: | France: Ministry of Health |
|
Ketamine Morphine PCA Hyperalgesia Nor-ketamine |
|
Anesthetics, Intravenous Morphine Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Anesthetics Central Nervous System Depressants Narcotics Excitatory Amino Acid Agents Anesthetics, Dissociative |
Pharmacologic Actions Sensory System Agents Anesthetics, General Therapeutic Uses Ketamine Peripheral Nervous System Agents Analgesics Central Nervous System Agents Analgesics, Opioid Excitatory Amino Acid Antagonists |