NCT01616004

Brief Summary

The purpose of this study is to determine whether N2O (laughing gas) has an antinociceptive effects in healthy volunteers.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
10

participants targeted

Target at below P25 for not_applicable pain

Timeline
Completed

Started Oct 2014

Typical duration for not_applicable pain

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 3, 2012

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 11, 2012

Completed
2.3 years until next milestone

Study Start

First participant enrolled

October 1, 2014

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2015

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2016

Completed
Last Updated

September 23, 2014

Status Verified

June 1, 2012

Enrollment Period

10 months

First QC Date

June 3, 2012

Last Update Submit

September 21, 2014

Conditions

Pain

Outcome Measures

Primary Outcomes (1)

  • Pain Scores on the Visual Analog Scale

    August 2016

Study Arms (2)

N2O

EXPERIMENTAL

N20 70% inhalation 5 minutes O2 100 % inhalation for 5 minutes

Drug: N2O

Air

SHAM COMPARATOR
Drug: Air

Interventions

N2ODRUG
Also known as: laughing gas
N2O
AirDRUG

sham comparator

Air

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • years old
  • women and men
  • healthy

You may not qualify if:

  • smokers
  • medication use pregnant woman cardiovascular disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tel Aviv Sourasky Medical Center, Pain Medicine Unit

Tel Aviv, Israel

Location

MeSH Terms

Conditions

Pain

Interventions

Nitrous OxideAir

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Nitrogen OxidesGasesInorganic ChemicalsNitrogen CompoundsOxidesOxygen CompoundsAtmosphereEnvironmentEcological and Environmental PhenomenaBiological PhenomenaMeteorological ConceptsEnvironment and Public Health

Study Officials

  • Silviu Brill, MD

    Tel-Aviv Sourasky Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Silviu Brill, M.D

CONTACT

972-3-6974477silviub@tasmc.health.gov.il

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 3, 2012

First Posted

June 11, 2012

Study Start

October 1, 2014

Primary Completion

August 1, 2015

Study Completion

August 1, 2016

Last Updated

September 23, 2014

Record last verified: 2012-06

Locations

IL(1)