Effect of Acute Treatment With N2O on Inhibitory Pain Mec... | NCT01616004

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

NCT01616004

Sponsor

Tel-Aviv Sourasky Medical Center

Status

Unknown status

Last Update Posted

Sep 23, 2014Estimated

Enrollment

10Estimated

Phase

Not Applicable

Conditions

Pain

Interventions

Countries

Israel

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2012

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2014

Primary Completion Date

Aug 2015Estimated

Completion Date

Aug 2016Estimated

First Submitted Date

Jun 3, 2012

First Submission Date that Met QC Criteria

Jun 8, 2012

First Posted Date

Jun 11, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 21, 2014

Last Update Posted Date

Sep 23, 2014Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

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).

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

10Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
N2O	Experimental	N20 70% inhalation 5 minutes O2 100 % inhalation for 5 minutes	Drug: N2O
Air	Sham Comparator		Drug: Air

Interventions

Name	Type	Description	Arm Group Labels	Other Names
N2O	Drug		N2O	laughing gas
Air

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Pain Scores on the Visual Analog Scale		August 2016

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

18-50 years old
women and men
healthy

Exclusion Criteria:

smokers
medication use pregnant woman cardiovascular disease

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

50 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Silviu Brill, M.D	Contact	972-3-6974477		silviub@tasmc.health.gov.il

Overall Officials

Name	Affiliation	Role
Silviu Brill, MD	Tel-Aviv Sourasky Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Tel Aviv Sourasky Medical Center, Pain Medicine Unit		Tel Aviv			Israel

Condition Browse Module

MeSH Terms

ID	Term
D010146	Pain

Ancestor Terms

ID	Term
D009461	Neurologic Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D009609	Nitrous Oxide
D000388	Air

Ancestor Terms

ID	Term
D009589	Nitrogen Oxides
D005740	Gases
D007287	Inorganic Chemicals
D017672	Nitrogen Compounds

Browse Leaves

Not provided

Browse Branches

Not provided