The Effect of N2O on Chronic Neuropathic Pain Patients (N2O)

The Effect of N2O on Chronic Neuropathic Pain

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.).

Study Overview

• Status: Unknown
• Conditions: Neuropathic Pain
• Intervention / Treatment: Drug: N2O; Drug: Oxygen

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 Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• Israel
  • Tel Aviv, Israel
    • Pain Medicine Unit

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: N2O&Oxygen; 70% N2O & 30% Oxygen by Aspiration for 5 min	Drug: N2O
Placebo Comparator: Oxygen; 100% Oxygen by Aspiration for 5 min	Drug: Oxygen

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Tel-Aviv Sourasky Medical Center

Study record dates

Study Major Dates

• Study Start: September 1, 2014
• Primary Completion (Anticipated): December 1, 2015

Study Registration Dates

• First Submitted: July 15, 2014
• First Submitted That Met QC Criteria: September 18, 2014
• First Posted (Estimate): September 22, 2014

Study Record Updates

• Last Update Posted (Estimate): September 22, 2014
• Last Update Submitted That Met QC Criteria: September 18, 2014
• Last Verified: September 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Pain; Neurologic Manifestations; Neuromuscular Diseases; Peripheral Nervous System Diseases; Neuralgia
• Other Study ID Numbers: TASMC-14-SB-0318-CTIL