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Development and Evaluation of a Methadone Protocol for Severe Chronic Pain Management

NCT02335398 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 34

Last updated 2015-01-09

No results posted yet for this study

Summary

Methadone is a synthetic mu opioid agonist that has been proved as clinically effective in pain management. However, methadone usage for pain control in Thailand has been limited because physicians are not familiar with its dosing and concern about the risk of drug accumulation and cardiac arrhythmia. Therefore, this prospective study was conducted to evaluate the efficacy and safety of a methadone protocol in Thai patients with severe chronic noncancer and cancer pain.

Conditions

  • Pain, Chronic

Interventions

DRUG

Methadone

The starting methadone dose for naïve-opioid patients was 2.5-5 mg every 8-12 hours. In patients who required opioid rotation, the conversion ratios, morphine:methadone, were 4:1, 8:1, and 12:1 for patients receiving less than 90 mg of morphine, receiving 90-300 mg of morphine, and receiving more than 300 mg of morphine , respectively. A fixed dose ratio of 1:20 was applied for changing from transdermal fentanyl to oral methadone. Then, the daily calculated methadone dose was divided into 8-12 hourly dosing. Calculated rescue dose was estimated to be 10-15% of total daily dose of methadone which there was switched to be morphine syrup in the ratio of 1:4.

Sponsors & Collaborators

  • Mahidol University

    lead OTHER

Principal Investigators

  • Chuthamanee Suthisisang, Ph.D. · Thailand: Faculty of Pharmacy, Mahidol University

  • Phutsadee Pudchakan, Bsc.Pharm · Thailand: Faculty of Pharmacy, Mahidol University

  • Krittika Tanyasaensook, Ph.D. · Thailand: Faculty of Pharmacy, Mahidol University

  • Pongparadee Chaudakshetrin, M.D. · Thailand: Faculty of Medicine Siriraj Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-07-31
Primary Completion
2013-12-31
Completion
2013-12-31

Countries

  • Thailand

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02335398 on ClinicalTrials.gov