The Effect of N2O on Chronic Neuropathic Pain Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

EARLY_PHASE1

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-09-30

Brief Summary

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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.).

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Detailed Description

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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

Conditions

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Neuropathic Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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N2O&Oxygen

70% N2O \& 30% Oxygen by Aspiration for 5 min

Group Type EXPERIMENTAL

N2O

Intervention Type DRUG

Oxygen

100% Oxygen by Aspiration for 5 min

Group Type PLACEBO_COMPARATOR

Oxygen

Intervention Type DRUG

Interventions

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N2O

Intervention Type DRUG

Oxygen

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No