- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01616004
Effect of Acute Treatment With N2O on Inhibitory Pain Mechanisms in Healthy Subject (N2O)
September 21, 2014 updated by: Tel-Aviv Sourasky Medical Center
The purpose of this study is to determine whether N2O (laughing gas) has an antinociceptive effects in healthy volunteers.
Study Overview
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).
Study Type
Interventional
Enrollment (Anticipated)
10
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Tel Aviv, Israel
- Tel Aviv Sourasky Medical Center, Pain Medicine Unit
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 50 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 18-50 years old
- women and men
- healthy
Exclusion Criteria:
- smokers
- medication use pregnant woman cardiovascular disease
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Non-Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: N2O
N20 70% inhalation 5 minutes O2 100 % inhalation for 5 minutes
|
Other Names:
|
Sham Comparator: Air
|
sham comparator
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Pain Scores on the Visual Analog Scale
Time Frame: August 2016
|
August 2016
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2014
Primary Completion (Anticipated)
August 1, 2015
Study Completion (Anticipated)
August 1, 2016
Study Registration Dates
First Submitted
June 3, 2012
First Submitted That Met QC Criteria
June 8, 2012
First Posted (Estimate)
June 11, 2012
Study Record Updates
Last Update Posted (Estimate)
September 23, 2014
Last Update Submitted That Met QC Criteria
September 21, 2014
Last Verified
June 1, 2012
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- TASMC-12-SB-340-CTIL
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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