Methadone and Ketamine for Neuropathic Pain Treatment
Information source: Universidade Federal de Santa Maria
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Neuropathic Pain
Intervention: Methadone (Drug); Ketamine (Drug); Methadone plus Ketamine (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Universidade Federal de Santa Maria Official(s) and/or principal investigator(s): Juliano Ferreira, PhD, Principal Investigator, Affiliation: Federal University of Santa Catarina
Summary
Methadone and ketamine are effective for neuropathic pain management. However, the benefits
of the association of both drugs are uncertain. Here, the investigators 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.
Clinical Details
Official title: Management of Neuropathic Chronic Pain With Methadone Combined With Ketamine: Randomized, Double Blind, Active-controlled Clinical Trial
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: The primary outcome was pain intensity as assessed by visual analogical scale (VAS) scores
Secondary outcome: The secondary outcomes were the presence of burning and/or shooting pain, allodynia and side effects.
Detailed description:
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.
Eligibility
Minimum age: 22 Years.
Maximum age: 77 Years.
Gender(s): Both.
Criteria:
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
Locations and Contacts
University Hospital in Santa Maria, Santa Maria, Rio Grande do Sul 97105-900, Brazil
Additional Information
Starting date: January 2012
Last updated: September 5, 2014
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