Methadone and Ketamine for Neuropathic Pain Treatment

NCT ID: NCT02233452

Last Updated: 2014-09-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 37 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-01-31
• Study Completion Date: 2012-08-31

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.

Conditions

Neuropathic Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Methadone

Group treated with methadone solution.

Group Type: ACTIVE_COMPARATOR

Methadone

Intervention Type: DRUG

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)

Ketamine

Group treated with ketamine solution

Group Type: ACTIVE_COMPARATOR

Ketamine

Intervention Type: DRUG

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.

Methadone plus ketamine

Group treated with methadone plus ketamine solution

Group Type: ACTIVE_COMPARATOR

Methadone plus Ketamine

Intervention Type: DRUG

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.

Interventions

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)

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: DRUG

Other Intervention Names

Methadone hydrochloride, Cristália® (São Paulo, Brazil); S(+)-ketamine hydrochloride, Cristália®, São Paulo, Brazil; methadone and S(+)-ketamine, Cristália®, São Paulo, Brazil

Eligibility 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

• Minimum Eligible Age: 22 Years
• Maximum Eligible Age: 77 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Santa Casa de Misericórdia de Belo Horizonte

OTHER

Sponsor Role: collaborator

Hospital de Clinicas de Porto Alegre

OTHER

Sponsor Role: collaborator

Universidade Federal de Santa Maria

OTHER

Sponsor Role: lead

Responsible Party

Juliano Ferreira

PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Juliano Ferreira, PhD

Role: PRINCIPAL_INVESTIGATOR

Federal University of Santa Catarina

Locations

University Hospital in Santa Maria

Santa Maria, Rio Grande do Sul, Brazil

Countries

Brazil

Other Identifiers

Methadone plus ketamine

Identifier Type: -

Identifier Source: org_study_id