The Effect of N2O on Chronic Neuropathic Pain Patients

Early Phase 1

• Conditions: Neuropathic Pain
• Interventions: Drug: Oxygen; Drug: N2O

• Registration Number: NCT02246517
• Lead Sponsor: Tel-Aviv Sourasky Medical Center

Brief 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.).

Detailed 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

Study Timeline

• Study First Submitted: 2014-07-15
• Status Verified: 2014-09
• Study Start: 2014-09
• Study First Submitted QC: 2014-09-18
• Last Update Submitted: 2014-09-18
• Study First Posted: 2014-09-22
• Last Update Posted: 2014-09-22
• Primary Completion: 2015-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Oxygen	Oxygen	100% Oxygen by Aspiration for 5 min
N2O&Oxygen	N2O	70% N2O \& 30% Oxygen by Aspiration for 5 min

Primary Outcome Measures

Name	Time	Method
change in adult pain as measured by visual Analog Scale for Pain (VAS Pain)	baseline and average of week for 4 weeks	Assessment of pain in the last 24 hours before the visit by VAS

Secondary Outcome Measures

Name	Time	Method
change in adult pain as measured by Short-Form McGill Pain Questionnaire (SF-MPQ)	baseline and average of week for 4 weeks	Assessment of pain in the last 24 hours before the visit by SF-MPQ

Trial Locations

Locations (1)

Pain Medicine Unit; 🇮🇱 Tel Aviv, Israel