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Methadone Associated With Morphine for Cancer Pain

NCT ID: NCT03324815

Last Updated: 2017-10-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-03-02

Study Completion Date

2018-08-30

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.

Conditions

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Cancer

Keywords

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Morphine Methadone Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Morphine- Methadone

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

Group Type ACTIVE_COMPARATOR

Morphine

Intervention Type DRUG

Pain Treatment

Methadone

Intervention Type DRUG

Pain Treatment

Morphine

Morphine: 5mg/6h

Group Type ACTIVE_COMPARATOR

Morphine

Intervention Type DRUG

Pain Treatment

Interventions

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Morphine

Pain Treatment

Intervention Type DRUG

Methadone

Pain Treatment

Intervention Type DRUG

Other Intervention Names

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Dimorf Mytedom

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Federal University of São Paulo

OTHER

Sponsor Role lead

Responsible Party

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Feliciano Contardo Nepomuceno Duarte

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Rioko K Sakata, MD; PhD

Role: PRINCIPAL_INVESTIGATOR

Universidade Federal de São Paulo

Locations

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Rioko K Sakata

São Paulo, , Brazil

Site Status RECRUITING

Countries

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Brazil

Central Contacts

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Feliciano NC Duarte, MD

Role: CONTACT

Phone: 55 11 99265 7272

Email: [email protected]

Facility Contacts

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Rioko K Sakata, PhD

Role: primary

References

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Duarte FCN, Ferraro LHDC, Ferreira A, Sakata RK. A Randomized Controlled Trial Evaluating the Analgesic Effect of the Combination of Methadone With Morphine for Cancer Related Pain. Clin J Pain. 2021 Sep 1;37(9):664-668. doi: 10.1097/AJP.0000000000000959.

Reference Type DERIVED
PMID: 34265791 (View on PubMed)

Other Identifiers

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30850414.0.0000.5505

Identifier Type: -

Identifier Source: org_study_id