Back to resultsAdministration of Ketamine to Prevent the Post-operative Pain (KETAMINE)
Primary Purpose
Postoperative Pain, Breast Cancer
Status
Completed
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
Ketamine
Sponsored by
About this trial
This is an interventional treatment trial for Postoperative Pain focused on measuring Post-operative-pain, Breast cancer, Morphine, Analgesia
Eligibility Criteria
Inclusion criteria: Patients 18 years older ASA class 1 or 2 with surgery of breast cancer (mastectomy or tumorectomy) Exclusion criteria: .Kétamine hypersensitivity Major psychiatric disorders Major cardio-vascular disorders Major neurologic disorders Major ocular disorders Morphine in pre-operative period
Sites / Locations
- Institut Bergonié - Centre Régional de Luttre Contre le Cancer de Bordeaux et du Sud Ouest
Outcomes
Primary Outcome Measures
Morphine consumption (first 48 post-operative hours)
Secondary Outcome Measures
Visual analog rating scale during the first 48 post-operative hours: at 15mn,1H,2H,12H, 24H,36H,48H
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00210210
Brief Title
Administration of Ketamine to Prevent the Post-operative Pain
Acronym
KETAMINE
Official Title
Effect of Ketamine, at the Induction and Its Maintenance to Prevent the Post-operative Pain: Clinical Trial in Cancerology
Study Type
Interventional
2. Study Status
Record Verification Date
October 2007
Overall Recruitment Status
Completed
Study Start Date
February 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2005 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Institut Bergonié
4. Oversight
5. Study Description
Brief Summary
The surgery of breast cancer is responsible for post-operative pain, needing in about 30% some morphine consumption; like that, the association of ketamine with general anaesthesia may decrease morphine's use and so its adverse effects. The purpose is to evaluate the analgesic effect of a receptor NMDA's antagonist ( ketamine)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain, Breast Cancer
Keywords
Post-operative-pain, Breast cancer, Morphine, Analgesia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
230 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Ketamine
Primary Outcome Measure Information:
Title
Morphine consumption (first 48 post-operative hours)
Secondary Outcome Measure Information:
Title
Visual analog rating scale during the first 48 post-operative hours: at 15mn,1H,2H,12H, 24H,36H,48H
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria:
Patients 18 years older
ASA class 1 or 2
with surgery of breast cancer (mastectomy or tumorectomy)
Exclusion criteria:
.Kétamine hypersensitivity
Major psychiatric disorders
Major cardio-vascular disorders
Major neurologic disorders
Major ocular disorders
Morphine in pre-operative period
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sylvie COLOMBANI, MD
Organizational Affiliation
Institut Bergonié
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institut Bergonié - Centre Régional de Luttre Contre le Cancer de Bordeaux et du Sud Ouest
City
Bordeaux
ZIP/Postal Code
33076
Country
France
12. IPD Sharing Statement
Learn more about this trial
Administration of Ketamine to Prevent the Post-operative Pain
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