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Completed

NCT Number: NCT00210210

Administration of Ketamine to Prevent the Post-operative Pain

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)

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Key information

Conditions

Postoperative Pain Agnosia Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Perceptual Disorders Postoperative Complications Signs and Symptoms Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–100 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Institut Bergonié - Centre Régional de Luttre Contre le Cancer de Bordeaux et du Sud Ouest

Bordeaux, 33076, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ketamine

Drug

Saline Solution

Drug

Primary outcomes

  1. Morphine Consumption (First 48 Post-operative Hours)

    Time frame: within 48 hours following surgery

    Number of participants with at least one consumption of morphine within 48 hours following surgery.

Secondary outcomes

  1. Post-operative Pain

    Time frame: 48 hours after surgery

    Count of participants with post-operative pain. Pain was measured using a Visual Analog Rating Scale (VAS), ranging from 0 (no pain) to 10 (pain).

    A VAS score >= 4 wwas considered as "Pain". A VAS sore <4 was considered as "No pain".

Sponsors and collaborators

Lead sponsor

Institut Bergonié

Other

Registry information

Official study title

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

Acronym: KETAMINE

Important dates

Study start
2004
Primary completion
2005
Study completion
2005
First posted
Sep 21, 2005
Registry last updated
Sep 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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