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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

Tracking Information
First Submitted Date  ICMJE August 22, 2014
First Posted Date  ICMJE September 8, 2014
Last Update Posted Date September 8, 2014
Study Start Date  ICMJE January 2012
Actual Primary Completion Date August 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 5, 2014)
The primary outcome was pain intensity as assessed by visual analogical scale (VAS) scores [ Time Frame: 90 days ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: September 5, 2014)
The secondary outcomes were the presence of burning and/or shooting pain, allodynia and side effects. [ Time Frame: 90 days ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Methadone and Ketamine for Neuropathic Pain Treatment
Official Title  ICMJE Management of Neuropathic Chronic Pain With Methadone Combined With Ketamine: Randomized, Double Blind, Active-controlled Clinical Trial
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Neuropathic Pain
Intervention  ICMJE
  • 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)
  • 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
  • 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
Study Arms  ICMJE
  • Active Comparator: Methadone
    Group treated with methadone solution.
    Intervention: Drug: Methadone
  • Active Comparator: Ketamine
    Group treated with ketamine solution
    Intervention: Drug: Ketamine
  • Active Comparator: Methadone plus ketamine
    Group treated with methadone plus ketamine solution
    Intervention: Drug: Methadone plus Ketamine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 5, 2014)
37
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE August 2012
Actual Primary Completion Date August 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 22 Years to 77 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Brazil
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02233452
Other Study ID Numbers  ICMJE Methadone plus ketamine
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Juliano Ferreira, Universidade Federal de Santa Maria
Study Sponsor  ICMJE Universidade Federal de Santa Maria
Collaborators  ICMJE
  • Santa Casa de Misericórdia de Belo Horizonte
  • Hospital de Clinicas de Porto Alegre
Investigators  ICMJE
Principal Investigator: Juliano Ferreira, PhD Federal University of Santa Catarina
PRS Account Universidade Federal de Santa Maria
Verification Date September 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP