The Effect of N2O on Chronic Neuropathic Pain Patients (N2O)
Primary Purpose
Neuropathic Pain
Status
Unknown status
Phase
Early Phase 1
Locations
Israel
Study Type
Interventional
Intervention
N2O
Oxygen
Sponsored by
About this trial
This is an interventional treatment trial for Neuropathic Pain
Eligibility 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
Sites / Locations
- Pain Medicine Unit
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
N2O&Oxygen
Oxygen
Arm Description
70% N2O & 30% Oxygen by Aspiration for 5 min
100% Oxygen by Aspiration for 5 min
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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
Full Information
NCT ID
NCT02246517
First Posted
July 15, 2014
Last Updated
September 18, 2014
Sponsor
Tel-Aviv Sourasky Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT02246517
Brief Title
The Effect of N2O on Chronic Neuropathic Pain Patients
Acronym
N2O
Official Title
The Effect of N2O on Chronic Neuropathic Pain
Study Type
Interventional
2. Study Status
Record Verification Date
September 2014
Overall Recruitment Status
Unknown status
Study Start Date
September 2014 (undefined)
Primary Completion Date
December 2015 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tel-Aviv Sourasky Medical Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neuropathic Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
N2O&Oxygen
Arm Type
Experimental
Arm Description
70% N2O & 30% Oxygen by Aspiration for 5 min
Arm Title
Oxygen
Arm Type
Placebo Comparator
Arm Description
100% Oxygen by Aspiration for 5 min
Intervention Type
Drug
Intervention Name(s)
N2O
Intervention Type
Drug
Intervention Name(s)
Oxygen
Primary Outcome Measure Information:
Title
change in adult pain as measured by visual Analog Scale for Pain (VAS Pain)
Description
Assessment of pain in the last 24 hours before the visit by VAS
Time Frame
baseline and average of week for 4 weeks
Secondary Outcome Measure Information:
Title
change in adult pain as measured by Short-Form McGill Pain Questionnaire (SF-MPQ)
Description
Assessment of pain in the last 24 hours before the visit by SF-MPQ
Time Frame
baseline and average of week for 4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Pain Medicine Unit
City
Tel Aviv
Country
Israel
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lior Dayan, M.D
Phone
972-50-4051014
First Name & Middle Initial & Last Name & Degree
Silviu Brill, M.D
12. IPD Sharing Statement
Learn more about this trial
The Effect of N2O on Chronic Neuropathic Pain Patients
We'll reach out to this number within 24 hrs