Adverse Event Risk Assessment in the Use of Nitrous Oxide for Pediatric Dental Patients

NCT ID: NCT02909816

Last Updated: 2018-04-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

364 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-04-30

Study Completion Date

2018-04-30

Brief Summary

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The objective was to assess adverse event risk in the use of Nitrous Oxide for Pediatric Dental Patients. The investigators performed a multicenter observational study. The investigators included patients aged 1 to 18 years and who have already failed dental care because of non-cooperation; they could be with mental or cognitive disabilities and could have sedative premedication. The investigators performed any type of dental care With the Use of Nitrous Oxide/Oxygen Sedation. The primary outcome was vomiting assessed during or after dental care.

Detailed Description

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Conditions

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Dental Carie; Orthodontics

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Patients under 18 years
* Use of nitrous oxide/oxygen analgesia/anxiolysis
* Any type of dental care

Exclusion Criteria

* Use of midazolam
* Use of general anesthesia
Minimum Eligible Age

1 Year

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role lead

Responsible Party

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Frederic COURSON

PhD, DDS

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Violaine Smaïl-Faugeron, PhD, DDS

Role: PRINCIPAL_INVESTIGATOR

Assistance Publique - Hôpitaux de Paris

Locations

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Violaine Smaïl-Faugeron

Paris, , France

Site Status

Countries

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France

Other Identifiers

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MEOPA

Identifier Type: -

Identifier Source: org_study_id

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