Development and Evaluation of a Methadone Protocol for Severe Chronic Pain Management
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|ClinicalTrials.gov Identifier: NCT02335398|
Recruitment Status : Completed
First Posted : January 9, 2015
Last Update Posted : January 9, 2015
|Condition or disease||Intervention/treatment||Phase|
|Pain, Chronic||Drug: Methadone||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||34 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Development and Evaluation of a Methadone Protocol for Severe Chronic Pain Management|
|Study Start Date :||July 2011|
|Actual Primary Completion Date :||December 2013|
|Actual Study Completion Date :||December 2013|
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 Name: Methadone GPO
- Pain score [ Time Frame: 3 months ]pain scores are assessed at baseline, and two, four, eight, and twelve weeks after starting methadone.
- pain interferences scores [ Time Frame: 3 months ]pain interferences scores are assessed at baseline, and two, four, eight, and twelve weeks after starting methadone.
- 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
- QTc intervals [ Time Frame: 3 months ]QTc intervals are assessed at baseline, and two, four, eight, and twelve weeks after starting methadone
- Neuropathic pain score [ Time Frame: 3 months ]Neuropathic pain score are assessed at baseline, and two, four, eight, and twelve weeks after starting methadone
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02335398
|Bangkoknoi, Bangkok, Thailand, 10700|
|Study Chair:||Chuthamanee Suthisisang, Ph.D.||Thailand: Faculty of Pharmacy, Mahidol University|
|Principal Investigator:||Phutsadee Pudchakan, Bsc.Pharm||Thailand: Faculty of Pharmacy, Mahidol University|
|Study Director:||Krittika Tanyasaensook, Ph.D.||Thailand: Faculty of Pharmacy, Mahidol University|
|Study Director:||Pongparadee Chaudakshetrin, M.D.||Thailand: Faculty of Medicine Siriraj Hospital|