NCT02246517

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.).

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at P25-P50 for early_phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 15, 2014

Completed
2 months until next milestone

Study Start

First participant enrolled

September 1, 2014

Completed
21 days until next milestone

First Posted

Study publicly available on registry

September 22, 2014

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Last Updated

September 22, 2014

Status Verified

September 1, 2014

Enrollment Period

1.2 years

First QC Date

July 15, 2014

Last Update Submit

September 18, 2014

Conditions

Neuropathic Pain

Outcome Measures

Primary Outcomes (1)

  • 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

    baseline and average of week for 4 weeks

Secondary Outcomes (1)

  • change in adult pain as measured by Short-Form McGill Pain Questionnaire (SF-MPQ)

    baseline and average of week for 4 weeks

Study Arms (2)

N2O&Oxygen

EXPERIMENTAL

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

Drug: N2O

Oxygen

PLACEBO COMPARATOR

100% Oxygen by Aspiration for 5 min

Drug: Oxygen

Interventions

N2ODRUG
N2O&Oxygen
OxygenDRUG
Oxygen

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • patients that suffer from chronic lung disease.
  • patients with cancer
  • patients with heart disease
  • pregnant and lactate woman
  • patients that suffer from depression

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pain Medicine Unit

Tel Aviv, Israel

Location

MeSH Terms

Conditions

Neuralgia

Interventions

Oxygen

Condition Hierarchy (Ancestors)

Peripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

ChalcogensElementsInorganic ChemicalsGases

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

July 15, 2014

First Posted

September 22, 2014

Study Start

September 1, 2014

Primary Completion

December 1, 2015

Last Updated

September 22, 2014

Record last verified: 2014-09

Locations

IL(1)