The Effect of N2O on Chronic Neuropathic Pain Patients

Neuropathic Pain Clinical Trial

— N2O  

Official title:

The Effect of N2O on Chronic Neuropathic Pain

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02246517
• Other study ID #: TASMC-14-SB-0318-CTIL
• Status: Not yet recruiting
• Phase: Phase 0
• First received: July 15, 2014
• Last updated: September 18, 2014
• Start date: September 2014

Study information

• Verified date: September 2014
• Source: Tel-Aviv Sourasky Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

Important pharmacological agents for treatment of chronic neuropathic pain such as ketamine block NMDA receptors. Nitrous oxide, an inhalant agent used extensively In anesthesia, also have antagonist property of NMDA receptors. The investigators hypothesize that prolonged treatment with N2O can alleviate chronic neuropathic pain of different causes (e.g. diabetic neuropathy, post herpetic neuralgia etc.).

Description:

Important pharmacological agents for treatment of chronic neuropathic pain such as ketamine block NMDA receptors. Nitrous oxide, an inhalant agent used extensively In anesthesia, also have antagonist property of NMDA receptors. The investigators hypothesize that prolonged treatment with N2O can alleviate chronic neuropathic pain of different causes (e.g. diabetic neuropathy, post herpetic neuralgia etc.). In order to examine our theory we Will recruit 40 patients aged 18-65 that suffer from chronic neuropathic pain. The patients will be divided to two groups of which half will receive treatment with N2O and half with placebo (pure O2) as a repeated weekly treatment for 4 weeks. At the beginning of the each session the patient will be asked to fill questionnaires regarding their pain quality and severity

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• men and women at the age 18-65

• patient that suffer from chronic neuropathic pain

• VAS>40

• DN4 score >4

• takes pain medication on a regular basis

• Didn't get epidural injection for the pas month

• signed an informed consent form

Exclusion Criteria:

• patients that suffer from chronic lung disease.

• patients with cancer

• patients with heart disease

• pregnant and lactate woman

• patients that suffer from depression

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Neuralgia
• Neuropathic Pain

Intervention

Drug:
• N2O

• Oxygen

Locations

Country	Name	City	State
Israel	Pain Medicine Unit	Tel Aviv

Sponsors (1)

Lead Sponsor	Collaborator
Tel-Aviv Sourasky Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change in adult pain as measured by visual Analog Scale for Pain (VAS Pain)	Assessment of pain in the last 24 hours before the visit by VAS	baseline and average of week for 4 weeks	No
Secondary	change in adult pain as measured by Short-Form McGill Pain Questionnaire (SF-MPQ)	Assessment of pain in the last 24 hours before the visit by SF-MPQ	baseline and average of week for 4 weeks	No