Methadone and Ketamine for Neuropathic Pain Treatment

NCT02233452 | Completed Phase 4 DMC

• 1 other identifier: Methadone plus ketamine
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

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.

Conditions

Neuropathic Pain

Keywords

Neuropathic pain; Methadone; Ketamine; Multimodal analgesia

Outcome Measures

Primary Outcomes (1)

• The primary outcome was pain intensity as assessed by visual analogical scale (VAS) scores

  90 days

Secondary Outcomes (1)

• The secondary outcomes were the presence of burning and/or shooting pain, allodynia and side effects.

  90 days

Study Arms (3)

Methadone

ACTIVE COMPARATOR

Group treated with methadone solution.

Drug: Methadone

Ketamine

ACTIVE COMPARATOR

Group treated with ketamine solution

Drug: Ketamine

Methadone plus ketamine

ACTIVE COMPARATOR

Group treated with methadone plus ketamine solution

Drug: Methadone plus Ketamine

Interventions

Methadone 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)

Also known as: Methadone hydrochloride, Cristália® (São Paulo, Brazil)

Methadone

Ketamine 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.

Also known as: S(+)-ketamine hydrochloride, Cristália®, São Paulo, Brazil

Ketamine

Methadone plus Ketamine 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.

Also known as: methadone and S(+)-ketamine, Cristália®, São Paulo, Brazil

Methadone plus ketamine

Eligibility Criteria

• Age: 22 Years - 77 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• patients with a history of severe psychiatric disorder,
• misuse of illegal drugs or
• hepatic disease

Sponsors & Collaborators

• Universidade Federal de Santa Maria: lead
• Santa Casa de Misericórdia de Belo Horizonte: collaborator
• Hospital de Clinicas de Porto Alegre: collaborator

Study Sites (1)

University Hospital in Santa Maria

Santa Maria, Rio Grande do Sul, 97105-900, Brazil

Location

MeSH Terms

Conditions

Neuralgia

Interventions

Methadone; Ketamine

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ketones; Organic Chemicals; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons

Study Officials

• Juliano Ferreira, PhD

  Federal University of Santa Catarina

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: August 22, 2014
• First Posted: September 8, 2014
• Study Start: January 1, 2012
• Primary Completion: August 1, 2012
• Study Completion: August 1, 2012
• Last Updated: September 8, 2014

Record last verified: 2014-09

Locations

BR (1)