Administration of Ketamine to Prevent the Post-operative Pain

Ketamine

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)

Intervention / Treatment

  • Ketamine (DRUG)
    N/A

Condition or Disease

  • Postoperative Pain
  • Breast Cancer

Phase

  • Phase 3

    • Study Design

    Study type: INTERVENTIONAL
    Status: Completed
    Study results: No Results Available
    Age: 18 Years and older   (Adult, Older Adult)
    Enrollment: 230 (ACTUAL)
    Funded by: Other
    Allocation: Randomized
    Primary Purpose: Treatment

    Masking

    Clinical Trial Dates

    Start date: Feb 01, 2004
    Primary Completion: Aug 31, 2020
    Completion Date: Dec 01, 2005 ACTUAL
    Study First Posted: Sep 21, 2005 ESTIMATED
    Results First Posted: Aug 31, 2020
    Last Updated: Jul 25, 2013

    Sponsors / Collaborators

    Lead Sponsor: Institut Bergonié
    Responsible Party: N/A
    No responsible party listed

    Location

    Bordeaux, Nouvelle-Aquitaine, France

    Eligibility Criteria

    Sex: Female
    Minimum Age: 18
    Age Groups: Adult / Older Adult
    Healthy Volunteers: Yes

    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

    Primary Outcomes
    • Morphine consumption (first 48 post-operative hours)
    Secondary Outcomes
    • Visual analog rating scale during the first 48 post-operative hours: at 15mn,1H,2H,12H, 24H,36H,48H

    More Details

    NCT Number: NCT00210210
    Acronym: KETAMINE
    Other IDs: IB2004-04
    Study URL: https://clinicaltrials.gov/study/NCT00210210
    Last updated: Sep 29, 2023