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

Assistance Publique - Hôpitaux de Paris364 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

364

Conditions

Dental Carie; Orthodontics

Eligibility

Sex: ALLMin age: 1 YearMax age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Violaine Smaïl-Faugeron

Paris, France

Outcomes

Primary Outcomes

occurrence of vomiting

Time frame: from the beginning of Nitrous Oxide/Oxygen administration up to half an hour after the end of dental treatment

Data from ClinicalTrials.gov

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