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Completed

NCT Number: NCT02335398

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

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.

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Key information

Conditions

Pain, Chronic Cancer Pain Chronic Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Siriraj Hospital

Bangkoknoi, Bangkok, 10700, Thailand

About this study

Chronic pain is defined as pain that persists beyond normal tissue healing time, which is assumed for 3 months by the IASP. The symptoms include either continuous or intermittent pain, that could be caused by tumor or other multiple etiologies. The consequence of uncontrolled chronic pain presents not only physiologic symptoms but also psychiatric disorders leading to severely impact daily living.

In Thailand, the use of methadone for pain management has been limited because physicians are not familiar with its dosing and concern about the risk of drug accumulation and cardiac arrhythmia. Therefore, the aim of this study is to evaluate the efficacy and safety of a protocol of methadone dosing in outpatients with severe chronic pain.

Thirty four chronic pain patients will be included to initiate methadone use following the protocol. Pain scores, pain interferences scores, neuropathic pain score, severity of adverse effects, and QTc intervals will be assessed at baseline, and two, four, eight, and twelve weeks after starting methadone.

The approved protocol of methadone therapy obtained from this study could be clinically utilized by physicians for severe chronic pain management.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Outpatients aged 18 or over who suffered from severe chronic cancer or noncancer pain to be firstly treated with methadone as analgesics

Exclusion criteria

  • QTc interval that was more than 500 msec
  • History of opioid addiction
  • Having structural heart diseases
  • During pregnancy or lactation period
  • Patients who have hypersensitivity to methadone

Treatment and study plan

Methadone

Drug

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.

Other names: Methadone GPO

Primary outcomes

  1. Pain score

    Time frame: 3 months

    pain scores are assessed at baseline, and two, four, eight, and twelve weeks after starting methadone.

Secondary outcomes

  1. pain interferences scores

    Time frame: 3 months

    pain interferences scores are assessed at baseline, and two, four, eight, and twelve weeks after starting methadone.

  2. severity of adverse effects

    Time frame: 3 months

    severity of adverse effects are assessed at baseline, and two, four, eight, and twelve weeks after starting methadone

  3. QTc intervals

    Time frame: 3 months

    QTc intervals are assessed at baseline, and two, four, eight, and twelve weeks after starting methadone

  4. Neuropathic pain score

    Time frame: 3 months

    Neuropathic pain score are assessed at baseline, and two, four, eight, and twelve weeks after starting methadone

Sponsors and collaborators

Lead sponsor

Mahidol University

Other

Registry information

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Jan 9, 2015
Registry last updated
Jan 9, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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