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

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ClinicalTrials.gov Identifier: NCT02246517
Recruitment Status : Unknown
Verified September 2014 by michal roll, Tel-Aviv Sourasky Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : September 22, 2014
Last Update Posted : September 22, 2014
Sponsor:
Information provided by (Responsible Party):
michal roll, 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.).

Condition or disease Intervention/treatment Phase
Neuropathic Pain Drug: N2O Drug: Oxygen Early Phase 1

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effect of N2O on Chronic Neuropathic Pain
Study Start Date : September 2014
Estimated Primary Completion Date : December 2015

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  1. change in adult pain as measured by visual Analog Scale for Pain (VAS Pain) [ Time Frame: baseline and average of week for 4 weeks ]
    Assessment of pain in the last 24 hours before the visit by VAS


Secondary Outcome Measures :
  1. change in adult pain as measured by Short-Form McGill Pain Questionnaire (SF-MPQ) [ Time Frame: baseline and average of week for 4 weeks ]
    Assessment of pain in the last 24 hours before the visit by SF-MPQ



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02246517


Locations
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Israel
Pain Medicine Unit
Tel Aviv, Israel
Contact: Lior Dayan, M.D    972-50-4051014      
Principal Investigator: Silviu Brill, M.D         
Sponsors and Collaborators
Tel-Aviv Sourasky Medical Center

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Responsible Party: michal roll, Dr, Tel-Aviv Sourasky Medical Center
ClinicalTrials.gov Identifier: NCT02246517    
Other Study ID Numbers: TASMC-14-SB-0318-CTIL
First Posted: September 22, 2014    Key Record Dates
Last Update Posted: September 22, 2014
Last Verified: September 2014
Additional relevant MeSH terms:
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Neuralgia
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Pain
Neurologic Manifestations
Signs and Symptoms
Nitrous Oxide
Anesthetics, Inhalation
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents