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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02909816

Enrollment

364

Registered

2016-09-21

Start date

2015-04-30

Completion date

2018-04-30

Last updated

2018-04-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dental Carie; Orthodontics

Brief summary

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

1 Years to 18 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

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

Countries

France

Outcome results