Methadone and Ketamine for Neuropathic Pain Treatment

Phase 4

Completed

• Conditions: Neuropathic Pain
• Interventions: Drug: Ketamine; Drug: Methadone plus Ketamine; Drug: Methadone

• Registration Number: NCT02233452
• Lead Sponsor: Universidade Federal de Santa Maria

Brief 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.

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.

Study Timeline

• Study Start: 2012-01
• Primary Completion: 2012-08
• Study Completion: 2012-08
• Study First Submitted: 2014-08-22
• Status Verified: 2014-09
• Study First Submitted QC: 2014-09-05
• Last Update Submitted: 2014-09-05
• Study First Posted: 2014-09-08
• Last Update Posted: 2014-09-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 37

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Ketamine	Ketamine	Group treated with ketamine solution
Methadone plus ketamine	Methadone plus Ketamine	Group treated with methadone plus ketamine solution
Methadone	Methadone	Group treated with methadone solution.

Primary Outcome Measures

Name	Time	Method
The primary outcome was pain intensity as assessed by visual analogical scale (VAS) scores	90 days

Secondary Outcome Measures

Name	Time	Method
The secondary outcomes were the presence of burning and/or shooting pain, allodynia and side effects.	90 days

Trial Locations

Locations (1)

University Hospital in Santa Maria; 🇧🇷 Santa Maria, Rio Grande do Sul, Brazil