Administration of Ketamine to Prevent the Post-operative Pain (KETAMINE)

This study has been completed.
Sponsor:
Information provided by:
Institut Bergonié
ClinicalTrials.gov Identifier:
NCT00210210
First received: September 13, 2005
Last updated: July 25, 2013
Last verified: October 2007

September 13, 2005
July 25, 2013
February 2004
Not Provided
Morphine consumption (first 48 post-operative hours)
Same as current
Complete list of historical versions of study NCT00210210 on ClinicalTrials.gov Archive Site
Visual analog rating scale during the first 48 post-operative hours: at 15mn,1H,2H,12H, 24H,36H,48H
Same as current
Not Provided
Not Provided
 
Administration of Ketamine to Prevent the Post-operative Pain
Effect of Ketamine, at the Induction and Its Maintenance to Prevent the Post-operative Pain: Clinical Trial in Cancerology

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)

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
  • Postoperative Pain
  • Breast Cancer
Drug: Ketamine
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
230
December 2005
Not Provided

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
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT00210210
IB2004-04, KETAMINE
Not Provided
Not Provided
Institut Bergonié
Not Provided
Principal Investigator: Sylvie COLOMBANI, MD Institut Bergonié
Institut Bergonié
October 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP