Adverse Event Risk Assessment in the Use of Nitrous Oxide... | NCT02909816

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

NCT02909816

Sponsor

Assistance Publique - Hôpitaux de Paris

Status

Completed

Last Update Posted

Apr 20, 2018Actual

Enrollment

364Actual

Phase

Not provided

Conditions

Dental Carie; Orthodontics

Interventions

Not provided

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2015

Primary Completion Date

Sep 2016Actual

Completion Date

Apr 2018Actual

First Submitted Date

Sep 9, 2016

First Submission Date that Met QC Criteria

Sep 20, 2016

First Posted Date

Sep 21, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 19, 2018

Last Update Posted Date

Apr 20, 2018Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Frederic COURSON, PhD, DDS, Assistance Publique - Hôpitaux de ParisPrincipal Investigator

Lead Sponsor

Assistance Publique - Hôpitaux de ParisOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

364Actual

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

1 Year

Maximum Age

18 Years

Standard Ages

ChildAdult

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Violaine Smaïl-Faugeron, PhD, DDS	Assistance Publique - Hôpitaux de Paris	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Violaine Smaïl-Faugeron		Paris		75018	France

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided