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The Effect of N2O on Chronic Neuropathic Pain Patients

T

Tel Aviv Sourasky Medical Center

Status and phase

Unknown
Early Phase 1

Conditions

Neuropathic Pain

Treatments

Drug: N2O
Drug: Oxygen

Study type

Interventional

Funder types

Other

Identifiers

NCT02246517
TASMC-14-SB-0318-CTIL

Details and patient eligibility

About

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.).

Full 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

Enrollment

20 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Quadruple Blind

20 participants in 2 patient groups, including a placebo group

N2O&Oxygen
Experimental group
Description:
70% N2O \& 30% Oxygen by Aspiration for 5 min
Treatment:
Drug: N2O
Oxygen
Placebo Comparator group
Description:
100% Oxygen by Aspiration for 5 min
Treatment:
Drug: Oxygen

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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