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Clinical Trials/NCT00643838
NCT00643838CompletedPhase 3

Sedation Faisability by Inhalation of Kalinox 170 Bar During Therapeutic Cares in Primary Care Dental Centers

Air Liquide Santé International1 site in 1 country549 target enrollmentStarted: December 1, 2007Last updated:
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Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 3
Status
Completed
Sponsor
Enrollment
549
Locations
1
Primary Endpoint
Pain measurement by using Visual Analog Scale (VAS) and Face Pain Scale (FPS)
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

A 50% nitrous oxide / 50% oxygen premix is administrated to the patient during the realization of dental cares. This openly clinical trial is done in 36 French primary care dental centers, especially on anxious and phobic patients but also on infants or mental deficient adults. At least 480 patients will be included in this clinical protocol.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
1 Year to — (Child, Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •anxious and/or phobic patients having a vomiting reflex
  • •very young children requiring selective dental cares
  • •mental deficient patient
  • •patient having specific phobia linked to the dental care to be done
  • •patient from 1 year old
  • •ASA 1 or ASA 2 patient
  • •existing of efficient contraception

Exclusion Criteria

  • •ASA 3 or ASA 4 patient
  • •patient already treated without using Kalinox's sedation
  • •patient already included in this protocol in a delay lower than 7 days
  • •contraindication linked to the experimental product
  • •Kalinox's inhalation duration higher than 1 hour
  • •pregnant or breast-feeding women

Arms & Interventions

A

Experimental

Misture of 50% nitrous oxide and 50% oxygen

Intervention: Kalinox 170 bar (Drug)

Outcomes

Primary Outcomes

Pain measurement by using Visual Analog Scale (VAS) and Face Pain Scale (FPS)

Time Frame: At the end of the dental care

Secondary Outcomes

  • Patient's acceptance and doctor's satisfaction(At the end of dental care)

Investigators

Sponsor
Air Liquide Santé International
Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (1)

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