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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT01616004
Other study ID # TASMC-12-SB-340-CTIL
Secondary ID
Status Not yet recruiting
Phase N/A
First received June 3, 2012
Last updated September 21, 2014
Start date October 2014
Est. completion date August 2016

Study information

Verified date June 2012
Source Tel-Aviv Sourasky Medical Center
Contact Silviu Brill, M.D
Phone 972-3-6974477
Email silviub@tasmc.health.gov.il
Is FDA regulated No
Health authority Israel: Ministry of Health
Study type Interventional

Clinical Trial Summary

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


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).


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 10
Est. completion date August 2016
Est. primary completion date August 2015
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 50 Years
Eligibility Inclusion Criteria:

- 18-50 years old

- women and men

- healthy

Exclusion Criteria:

- smokers

- medication use pregnant woman cardiovascular disease

Study Design

Allocation: Non-Randomized, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Basic Science


Related Conditions & MeSH terms


Intervention

Drug:
N2O

Air
sham comparator

Locations

Country Name City State
Israel Tel Aviv Sourasky Medical Center, Pain Medicine Unit Tel Aviv

Sponsors (1)

Lead Sponsor Collaborator
Tel-Aviv Sourasky Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type Measure Description Time frame Safety issue
Primary Pain Scores on the Visual Analog Scale August 2016 No
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