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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

Tracking Information
First Submitted Date  ICMJE July 15, 2014
First Posted Date  ICMJE September 22, 2014
Last Update Posted Date September 22, 2014
Study Start Date  ICMJE September 2014
Estimated Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 18, 2014)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: September 18, 2014)
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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Effect of N2O on Chronic Neuropathic Pain Patients
Official Title  ICMJE The Effect of N2O on Chronic Neuropathic Pain
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 Type  ICMJE Interventional
Study Phase  ICMJE Early Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Neuropathic Pain
Intervention  ICMJE
  • Drug: N2O
  • Drug: Oxygen
Study Arms  ICMJE
  • Experimental: N2O&Oxygen
    70% N2O & 30% Oxygen by Aspiration for 5 min
    Intervention: Drug: N2O
  • Placebo Comparator: Oxygen
    100% Oxygen by Aspiration for 5 min
    Intervention: Drug: Oxygen
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: September 18, 2014)
20
Original Estimated Enrollment  ICMJE Same as current
Study Completion Date  ICMJE Not Provided
Estimated Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Israel
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02246517
Other Study ID Numbers  ICMJE TASMC-14-SB-0318-CTIL
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party michal roll, Tel-Aviv Sourasky Medical Center
Study Sponsor  ICMJE Tel-Aviv Sourasky Medical Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Tel-Aviv Sourasky Medical Center
Verification Date September 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP