Administration of Ketamine to Prevent the Post-operative Pain

Breast Cancer Clinical Trial

— KETAMINE  

Official title:

Effect of Ketamine, at the Induction and Its Maintenance to Prevent the Post-operative Pain: Clinical Trial in Cancerology

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00210210
• Other study ID #: IB2004-04
• Secondary ID: KETAMINE
• Status: Completed
• Phase: Phase 3
• First received: September 13, 2005
• Last updated: July 25, 2013
• Start date: February 2004
• Est. completion date: December 2005

Study information

• Verified date: October 2007
• Source: Institut Bergonié
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 230
• Est. completion date: December 2005
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Cancer
• Pain, Postoperative
• Postoperative Pain

Intervention

Drug:
• Ketamine

Locations

Country	Name	City	State
France	Institut Bergonié - Centre Régional de Luttre Contre le Cancer de Bordeaux et du Sud Ouest	Bordeaux

Sponsors (1)

Lead Sponsor	Collaborator
Institut Bergonié

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Morphine consumption (first 48 post-operative hours)
Secondary	Visual analog rating scale during the first 48 post-operative hours: at 15mn,1H,2H,12H, 24H,36H,48H