Methadone Associated With Morphine for Cancer Pain

Federal University of São Paulo

Status: Unknown

Conditions: Cancer

Treatments: Drug: Methadone; Drug: Morphine

Study type: Interventional

Funder types: Other

Identifiers

NCT03324815

30850414.0.0000.5505

Details and patient eligibility

About

The study was prospective, randomized. Patients with cancer pain were evaluated, one group receiving methadone with morphine and another group receiving morphine as the only opioid. Pain intensity, total morphine dose and adverse effects were evaluated.

Full description

Opioids are the most important analgesics for the relief of cancer pain. In addition tolerance and hyperalgesia may ocurr as a consequence of treatment with these drugs. Medications for pain relief may also cause increased pain. NMDA receptor blockers may prevent or reduce the development of hyperalgesia. Methadone is a weak NMDA receptor antagonist and therefore its association could prevent hyperalgesia. The primary endpoint of the study was whether the administration of low dose methadone associated with morphine promotes better analgesic effect in patients with cancer pain, And secondarily to assess whether there is a reduction in the total dose of opioid needed for pain relief, and whether reduction of the opioid-related adverse effects occurs.

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Approved by the Ethics Committee
• signed the informed consent
• cancer pain
• starting the WHO thirth analgesic ladder,

Exclusion criteria

• cognitive impairment
• psychiatric disease
• illicit drug user
• hypersensitivity to the study drugs
• pregnant

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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40 participants in 2 patient groups

Morphine- Methadone

Active Comparator group

Description:

Morphine 5mg/6h plus metadone: 2,5mg/12h

Treatment:

Drug: Morphine

Drug: Methadone

Morphine

Active Comparator group

Description:

Morphine: 5mg/6h

Treatment:

Drug: Morphine