Methadone Associated With Morphine for Cancer Pain

Overview

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 Title of Study: “Analgesic Effect Evaluation of Methadone Associated With Morphine for Cancer Pain: Prospective Randomized Study”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Outcomes Assessor)
  • Study Primary Completion Date: July 30, 2018

Detailed 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.

Interventions

  • Drug: Morphine
    • Pain Treatment
  • Drug: Methadone
    • Pain Treatment

Arms, Groups and Cohorts

  • Active Comparator: Morphine- Methadone
    • Morphine 5mg/6h plus metadone: 2,5mg/12h
  • Active Comparator: Morphine
    • Morphine: 5mg/6h

Clinical Trial Outcome Measures

Primary Measures

  • Opioid consumption
    • Time Frame: 3 months
    • Total dose of morphine used by the patient

Secondary Measures

  • Pain intensity
    • Time Frame: 3 months
    • Measure of pain intensity by verbal numerical rating score (VNRS – zero to 10) where 0 is no pain and 10 is the worst pain imaginable. Values between 0 and 3 mean a good result, between 4 and 6 a poor result and between 7 and 10 a very poor result.

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Federal University of São Paulo
  • Provider of Information About this Clinical Study
    • Principal Investigator: Feliciano Contardo Nepomuceno Duarte, Principal Investigator – Federal University of São Paulo
  • Overall Official(s)
    • Rioko K Sakata, MD; PhD, Principal Investigator, Universidade Federal de São Paulo
  • Overall Contact(s)
    • Feliciano NC Duarte, MD, 55 11 99265 7272, feliciano.contardo@gmail.com

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