Interest of re-Oxygenation After Inhalation of 50% Nitrous Oxide / 50% Oxygen Premix in Dental Cares - Tabular View

Tracking Information
First Received Date ^ICMJE	March 20, 2008
Last Updated Date	March 25, 2008
Start Date ^ICMJE	February 2004
Primary Completion Date	May 2007 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: March 25, 2008)	Measurement of SpO2 [ Time Frame: In continuous ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00643786 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: March 25, 2008)	Analysis of ambient air pollution by nitrous oxide and patient's acceptance [ Time Frame: In continuous ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures ^ICMJE	Same as current

Descriptive Information
Brief Title ^ICMJE	Interest of re-Oxygenation After Inhalation of 50% Nitrous Oxide / 50% Oxygen Premix in Dental Cares
Official Title ^ICMJE	Validation of a Kalinox's Administration Protocol for Dental Cares : Interest of re-Oxygenation and Pollution Control
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
Study Phase	Phase III
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Efficacy Study
Condition ^ICMJE	Dental Cares Under Kalinox's Inhalation
Intervention ^ICMJE	Drug: Oxygène Drug: Air Médical
Study Arms / Comparison Groups	Experimental: Oxygène Placebo Comparator: Air Médical
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Terminated
Enrollment ^ICMJE	128
Estimated Completion Date	June 2008
Primary Completion Date	May 2007 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	1 Year and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	France

Administrative Information
NCT ID ^ICMJE	NCT00643786
Responsible Party	Peter ONODY, MD, Air Liquide Santé International
Study ID Numbers ^ICMJE	EudraCT : 031003
Study Sponsor ^ICMJE	Air Liquide Santé International
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	Air Liquide Santé International
Verification Date	March 2008
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP