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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00797264
Other study ID # P060402
Secondary ID
Status Completed
Phase N/A
First received November 24, 2008
Last updated April 10, 2013
Start date November 2008
Est. completion date October 2010

Study information

Verified date April 2013
Source Assistance Publique - Hôpitaux de Paris
Contact n/a
Is FDA regulated No
Health authority France: Ministry of Health
Study type Interventional

Clinical Trial 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.


Description:

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


Recruitment information / eligibility

Status Completed
Enrollment 18
Est. completion date October 2010
Est. primary completion date October 2010
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- total hip arthroplasty

Exclusion Criteria:

- pre operative opioid administration

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
Ketamine-Morphine
Ketamine bolus preoperative and syringe pump peroperative, and morphine postoperative (PCA)
Morphine
Bolus preoperative of NaCl and syringe pump peroperative of NaCl, and morphine postoperative (PCA)
Postoperative PCA of Ketamine and morphine
Bolus preoperative of NaCl and syringe pump peroperative of Ketamine, and morphine postoperative (PCA)

Locations

Country Name City State
France Service d'anesthesie-reanimation - Hôpital Bicêtre Le Kremlin Bicêtre

Sponsors (1)

Lead Sponsor Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Morphine consumption in PACU and in hospitalisation room at 24 and 48 hours No
Secondary Postoperative Visual Analogic Score of pain in Recovery Room, at 24 and 48 hours, in the ward No
Secondary Postoperative Measure of mechanical hyperalgesia by Von Frey filament device 24 and 48 hours in the ward No
Secondary Postoperative measure Ketamine and Nor-Ketamine blood levels at 24 and 48 hours in the ward No
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