Methadone and Ketamine for Neuropathic Pain Treatment
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| ClinicalTrials.gov Identifier: NCT02233452 |
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Recruitment Status :
Completed
First Posted : September 8, 2014
Last Update Posted : September 8, 2014
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Neuropathic Pain | Drug: Methadone Drug: Ketamine Drug: Methadone plus Ketamine | Phase 4 |
Either oral methadone or ketamine have been used in neuropathic pain management, however, the benefits of the association of both drugs are uncertain. Here, we conducted a randomized, double-blind, in parallel, active controlled clinical trial to test the hypothesis that methadone combined ketamine (methadone/ketamine) is more effective than methadone or ketamine alone in reducing neuropathic pain.
Methods: Fourthly two patients with neuropathic pain refractory to conventional therapy were randomly assigned to receive during three months oral methadone (n= 13), ketamine (n=13) or methadone combined with ketamine (n=13). The primary outcome was pain score on visual analogical scale (VAS) assessed on baseline, 8, 15, 30, 60 and 90 days throughout the treatment, and the secondary outcomes were symptoms of neuropathic pain such as allodynia, burning or shooting pain as well the side effects.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 37 participants |
| Allocation: | Randomized |
| Intervention Model: | Factorial Assignment |
| Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
| Primary Purpose: | Treatment |
| Official Title: | Management of Neuropathic Chronic Pain With Methadone Combined With Ketamine: Randomized, Double Blind, Active-controlled Clinical Trial |
| Study Start Date : | January 2012 |
| Actual Primary Completion Date : | August 2012 |
| Actual Study Completion Date : | August 2012 |
| Arm | Intervention/treatment |
|---|---|
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Active Comparator: Methadone
Group treated with methadone solution.
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Drug: Methadone
The solution of methadone was prepared by mixing 10 ml of methadone (10 mg/ml) and 90 ml of saline 0.9% (Baxter, São Paulo, Brazil)
Other Name: Methadone hydrochloride, Cristália® (São Paulo, Brazil) |
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Active Comparator: Ketamine
Group treated with ketamine solution
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Drug: Ketamine
The solution of ketamine was prepared by mixing 20 ml of S(+)-ketamine hydrochloride (50 mg/ml, Cristália®, São Paulo, Brazil) and 80 ml of saline 0.9% (Baxter, São Paulo, Brazil), obtaining a concentration of 10 mg/ml of ketamine.
Other Name: S(+)-ketamine hydrochloride, Cristália®, São Paulo, Brazil |
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Active Comparator: Methadone plus ketamine
Group treated with methadone plus ketamine solution
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Drug: Methadone plus Ketamine
the solution of methadone, ketamine was prepared by mixing 10 ml of methadone hydrochloride (10 mg/ml, Cristália®, São Paulo, Brazil), 20 ml of S(+)-ketamine hydrochloride (50 mg/ml, Cristália®, São Paulo, Brazil) and 70 ml of saline 0.9% (Baxter, São Paulo, Brazil), obtaining a concentration of 1 mg/ml of methadone and 10 mg/ml of ketamine.
Other Name: methadone and S(+)-ketamine, Cristália®, São Paulo, Brazil |
- The primary outcome was pain intensity as assessed by visual analogical scale (VAS) scores [ Time Frame: 90 days ]
- The secondary outcomes were the presence of burning and/or shooting pain, allodynia and side effects. [ Time Frame: 90 days ]
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| Ages Eligible for Study: | 22 Years to 77 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- patients complaining of pain for more than 6 months with neuropathic pain poorly responsive to drugs used to treat neuropathic pain (i.e. opioid, non-opioid, anticonvulsants, antidepressants), who were 22 to 77 years old
Exclusion Criteria:
- patients with a history of severe psychiatric disorder,
- misuse of illegal drugs or
- hepatic disease
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): NCT02233452
| Brazil | |
| University Hospital in Santa Maria | |
| Santa Maria, Rio Grande do Sul, Brazil, 97105-900 | |
| Principal Investigator: | Juliano Ferreira, PhD | Federal University of Santa Catarina |
| Responsible Party: | Juliano Ferreira, PhD, Universidade Federal de Santa Maria |
| ClinicalTrials.gov Identifier: | NCT02233452 |
| Other Study ID Numbers: |
Methadone plus ketamine |
| First Posted: | September 8, 2014 Key Record Dates |
| Last Update Posted: | September 8, 2014 |
| Last Verified: | September 2014 |
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Neuropathic pain Methadone Ketamine Multimodal analgesia |
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Neuralgia Peripheral Nervous System Diseases Neuromuscular Diseases Nervous System Diseases Pain Neurologic Manifestations Ketamine Methadone Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Anesthetics, Dissociative |
Anesthetics, Intravenous Anesthetics, General Anesthetics Central Nervous System Depressants Excitatory Amino Acid Antagonists Excitatory Amino Acid Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Analgesics, Opioid Narcotics Antitussive Agents Respiratory System Agents |