Interest of Re-oxygenation After Inhalation of 50% Nitrou... | NCT00643786

Studies
Interest of Re-oxygenation After Inhalation of 50% Nitrous Oxide / 50% Oxygen Premix in Dental Cares

NCT00643786

Sponsor

Air Liquide Santé International

Status

Terminated

Last Update Posted

Jun 24, 2014Estimated

Enrollment

128Actual

Phase

Phase 3

Conditions

Dental Cares Under Kalinox's Inhalation

Interventions

Oxygène
Air Médical

Countries

France

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 2014

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2004

Primary Completion Date

May 2007Actual

Completion Date

Jun 2008Actual

First Submitted Date

Mar 20, 2008

First Submission Date that Met QC Criteria

Mar 25, 2008

First Posted Date

Mar 26, 2008Estimated

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

Jun 23, 2014

Last Update Posted Date

Jun 24, 2014Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

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 usefulness of re-oxygenation after inhalation of 50% nitrous oxide and 50% oxygen premix (Kalinox 170 bar) during dental care is studied and the pollution resulting from administration of Kalinox is also investigated.

Detailed Description

Not provided

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

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

128Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
A	Experimental	Oxygène	Drug: Oxygène
B	Placebo Comparator	Air Médical	Drug: Air Médical

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Oxygène	Drug	Flow of gas administrated to the patient between 4 and 15 litre/min during 5 minutes after the end of Kalinox's inhalation	A

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Measurement of SpO2		In continuous

Secondary Outcomes

Measure	Description	Time Frame
Analysis of ambient air pollution by nitrous oxide and patient's acceptance		In continuous

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

From 1 year old
anxious or phobic patients
very young children requiring selective dental cares
mental deficient patients
ASA 1 or ASA 2 patients

Exclusion Criteria:

ASA 3 or ASA 4 patients
contraindication linked to the experimental product
patients with mental disorder incompatible with the motory test
patients that have received anxiolytic treatment less than 2 hours before the dental care

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

1 Year

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
UFR Odontologie Equipe d'accueil 3847		Clermont-Ferrand		63000	France