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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02233452
Other study ID # Methadone plus ketamine
Secondary ID
Status Completed
Phase Phase 4
First received August 22, 2014
Last updated September 5, 2014
Start date January 2012
Est. completion date August 2012

Study information

Verified date September 2014
Source Universidade Federal de Santa Maria
Contact n/a
Is FDA regulated No
Health authority Brazil: National Committee of Ethics in Research
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 37
Est. completion date August 2012
Est. primary completion date August 2012
Accepts healthy volunteers No
Gender Both
Age group 22 Years to 77 Years
Eligibility 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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

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)
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.
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.

Locations

Country Name City State
Brazil University Hospital in Santa Maria Santa Maria Rio Grande do Sul

Sponsors (3)

Lead Sponsor Collaborator
Universidade Federal de Santa Maria Hospital de Clinicas de Porto Alegre, Santa Casa de Misericórdia de Belo Horizonte

Country where clinical trial is conducted

Brazil, 

Outcome

Type Measure Description Time frame Safety issue
Primary The primary outcome was pain intensity as assessed by visual analogical scale (VAS) scores 90 days Yes
Secondary The secondary outcomes were the presence of burning and/or shooting pain, allodynia and side effects. 90 days Yes
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