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Methadone and Ketamine for Neuropathic Pain Treatment

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ClinicalTrials.gov Identifier: NCT02233452
Recruitment Status : Completed
First Posted : September 8, 2014
Last Update Posted : September 8, 2014
Sponsor:
Collaborators:
Santa Casa de Misericórdia de Belo Horizonte
Hospital de Clinicas de Porto Alegre
Information provided by (Responsible Party):
Juliano Ferreira, 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.

Condition or disease Intervention/treatment Phase
Neuropathic Pain Drug: Methadone Drug: Ketamine Drug: Methadone plus Ketamine Phase 4

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 37 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Management of Neuropathic Chronic Pain With Methadone Combined With Ketamine: Randomized, Double Blind, Active-controlled Clinical Trial
Study Start Date : January 2012
Actual Primary Completion Date : August 2012
Actual Study Completion Date : August 2012

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Methadone
Group treated with methadone solution.
Drug: 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)
Other Name: Methadone hydrochloride, Cristália® (São Paulo, Brazil)

Active Comparator: Ketamine
Group treated with ketamine solution
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.
Other Name: S(+)-ketamine hydrochloride, Cristália®, São Paulo, Brazil

Active Comparator: Methadone plus ketamine
Group treated with methadone plus ketamine solution
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.
Other Name: methadone and S(+)-ketamine, Cristália®, São Paulo, Brazil




Primary Outcome Measures :
  1. The primary outcome was pain intensity as assessed by visual analogical scale (VAS) scores [ Time Frame: 90 days ]

Secondary Outcome Measures :
  1. The secondary outcomes were the presence of burning and/or shooting pain, allodynia and side effects. [ Time Frame: 90 days ]


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Ages Eligible for Study:   22 Years to 77 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02233452


Locations
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Brazil
University Hospital in Santa Maria
Santa Maria, Rio Grande do Sul, Brazil, 97105-900
Sponsors and Collaborators
Universidade Federal de Santa Maria
Santa Casa de Misericórdia de Belo Horizonte
Hospital de Clinicas de Porto Alegre
Investigators
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Principal Investigator: Juliano Ferreira, PhD Federal University of Santa Catarina

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Responsible Party: Juliano Ferreira, PhD, Universidade Federal de Santa Maria
ClinicalTrials.gov Identifier: NCT02233452     History of Changes
Other Study ID Numbers: Methadone plus ketamine
First Posted: September 8, 2014    Key Record Dates
Last Update Posted: September 8, 2014
Last Verified: September 2014
Keywords provided by Juliano Ferreira, Universidade Federal de Santa Maria:
Neuropathic pain
Methadone
Ketamine
Multimodal analgesia
Additional relevant MeSH terms:
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Neuralgia
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Pain
Neurologic Manifestations
Signs and Symptoms
Ketamine
Methadone
Pharmaceutical Solutions
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Analgesics, Opioid
Narcotics
Antitussive Agents
Respiratory System Agents