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

Institut Bergonié

Status and phase: Completed; Phase 3

Conditions: Postoperative Pain; Breast Cancer

Treatments: Drug: Ketamine; Drug: Saline solution

Study type: Interventional

Funder types: Other

Identifiers

NCT00210210

IB2004-04

KETAMINE

Details and patient eligibility

About

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)

Enrollment: 230 patients

Sex: Female

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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230 participants in 2 patient groups

Ketamine Arm

Experimental group

Description:

Anesthetic induction: Ketamine at 0.15 mg/kg is added to the "Reference protocol". Anesthetic maintenance: Ketamine at 2 mg/kg/min is added to the "Reference protocol".

Treatment:

Drug: Ketamine

Reference Arm

Sham Comparator group

Description:

Induction and anesthetic maintenance without ketamine (reference arm / saline solution)

Treatment:

Drug: Saline solution