Administration of Ketamine to Prevent the Post-operative Pain

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

230 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-01-31

Study Completion Date

2005-12-31

Brief Summary

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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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Detailed Description

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Conditions

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Postoperative Pain Breast Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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Ketamine Arm

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".

Group Type EXPERIMENTAL

Ketamine

Intervention Type DRUG

Reference Arm

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

Group Type SHAM_COMPARATOR

Saline solution

Intervention Type DRUG

Interventions

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Ketamine

Intervention Type DRUG

Saline solution

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No