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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

Page last updated: August 23, 2015

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