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Effect of Acute Treatment With N2O on Inhibitory Pain Mechanisms in Healthy Subject

This study is not yet open for participant recruitment.
Verified June 2012 by Tel-Aviv Sourasky Medical Center
Sponsor:
Information provided by (Responsible Party):
Tel-Aviv Sourasky Medical Center
ClinicalTrials.gov Identifier:
NCT01616004
First received: June 3, 2012
Last updated: June 8, 2012
Last verified: June 2012
History of Changes
  Purpose

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


Condition Intervention
Pain
 Drug: N2O
Drug: Air

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Primary Purpose: Basic Science
Official Title: Effect of Acute Treatment With N2O on Inhibitory Pain Mechanisms in Healthy Subject

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Tel-Aviv Sourasky Medical Center:

Primary Outcome Measures:
  • quantitative measurement of pain reaction (using eVAS from 0 to 100) to heat pain stimulus using QST-TSA

Estimated Enrollment: 10
Study Start Date: August 2012
Estimated Study Completion Date: August 2014
Estimated Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: N2O Drug: N2O
Other Name: laughing gas
Sham Comparator: Air Drug: Air
sham comparator

Detailed Description:

10 healthy volunteers will come twice to the pain medicine unit, at 1 visit they'll get N2O and in the second visit they'll get air as placebo, they won't know what they're getting. During the visit they'll get heat stimulus using QST and will have to report their pain using eVAS (scale from 0 to 100 when 0 is no pain and 100 is the worst pain imagine).

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 18-50 years old
  • women and men
  • healthy

Exclusion Criteria:

  • smokers
  • medication use pregnant woman cardiovascular disease
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01616004

Contacts
Contact: Silviu Brill, M.D 972-3-6974477 silviub@tasmc.health.gov.il

Locations
Israel
Tel Aviv Sourasky Medical Center, Pain Medicine Unit Not yet recruiting
Tel Aviv, Israel
Contact: silviu Brill, M.D     972-3-6974477     silviub@tasmc.health.gov.il    
Sponsors and Collaborators
Tel-Aviv Sourasky Medical Center
Investigators
Principal Investigator: Silviu Brill, MD Tel-Aviv Sourasky Medical Center
  More Information

No publications provided

Responsible Party: Tel-Aviv Sourasky Medical Center
ClinicalTrials.gov Identifier: NCT01616004     History of Changes
Other Study ID Numbers: TASMC-12-SB-340-CTIL
Study First Received: June 3, 2012
Last Updated: June 8, 2012
Health Authority: Israel: Ministry of Health

Additional relevant MeSH terms:
Nitrous Oxide
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
 Central Nervous System Agents
Therapeutic Uses
Anesthetics, Inhalation
Anesthetics, General
Anesthetics
Central Nervous System Depressants

ClinicalTrials.gov processed this record on June 17, 2013