Methadone Associated With Morphine for Cancer Pain

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Cancer

Intervention / Treatment
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* Drug: Morphine
* Drug: Methadone


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Morphine- Methadone<br>Morphine 5mg/6h plus metadone: 2,5mg/12h | Drug: Morphine<br>* Pain Treatment<br>* Other names: Dimorf;Drug: Methadone<br>* Pain Treatment<br>* Other names: Mytedom;|
| Active Comparator: Morphine<br>Morphine: 5mg/6h | Drug: Morphine<br>* Pain Treatment<br>* Other names: Dimorf;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Opioid consumption | Total dose of morphine used by the patient | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain intensity | 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. | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Morphine, Methadone, Pain