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

April 19, 2018 updated by: Frederic COURSON, Assistance Publique - Hôpitaux de Paris

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 Overview

Status

Completed

Conditions

Dental Carie; Orthodontics

Study Type

Observational

Enrollment (Actual)

364

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

France
- - Paris, France, 75018
    - Violaine Smaïl-Faugeron

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 18 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients under 18 years
Patients who have already failed dental care because of non-cooperation
Patients with or without mental or cognitive disabilities (regardless of type)
Patients with or without sedative premedication

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique - Hôpitaux de Paris

Investigators

Principal Investigator: Violaine Smaïl-Faugeron, PhD, DDS, Assistance Publique - Hôpitaux de Paris

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2015

Primary Completion (Actual)

September 1, 2016

Study Completion (Actual)

April 1, 2018

Study Registration Dates

First Submitted

September 9, 2016

First Submitted That Met QC Criteria

September 20, 2016

First Posted (Estimate)

September 21, 2016

Study Record Updates

Last Update Posted (Actual)

April 20, 2018

Last Update Submitted That Met QC Criteria

April 19, 2018

Last Verified