Study Aimed at Detecting Potential Abuse of Nitrous Oxide in Children During Dental Care (MEOPAeDent)

September 8, 2016 updated by: Nantes University Hospital

Uncontrolled Prospective Single-center Study Aimed at Detecting Potential Abuse of Nitrous Oxide in Children During Dental Care

The aim of this study is to evaluate the potential risk of abusive behavior for children in care using nitrous oxide for dental care.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The expected prospects are therefore maintaining surveillance around the MEOPA following his release from hospital reserves, but also to ensure that the MEOPA not an addictive potential in the context of its use in dentistry. The results of this study will in any case to secure its application for dental care.

Study Type

Observational

Enrollment (Actual)

76

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

3 years to 15 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

All patients seen in consultation EMENO and being younger than 15 years will be offered this study.

This is a population of non-cooperative patients to dental care or with a disability limiting their cooperation.

A quick questionnaire will be submitted in the consultations EMENO the SSC, the children after their parents' permission.

Description

Inclusion Criteria:

  • Children aged 3 to 15 years
  • Requiring dental care under MEOPA
  • Not opposing, as well as his parents, his participation in the study
  • Not having difficulties tracking (going on holiday, imminent change, remoteness, lack of motivation)

Exclusion Criteria:

Excluded patients are those whose dental care can be made to the vigil state, or on the contrary, will present a number of important care, justifying general anesthesia.

Also excluded will be children whose parents no longer have parental authority or whose parents are divorced or divorcing.

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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
presence of clear signs that the child is trying to extend the contact MEOPA ( questionnaire )
Time Frame: Baseline
hand gesture to keep the mask over the nose and / or mouth, verbalization of the desire to keep the mask over the nose and / or mouth, to extend the negotiation contac
Baseline

Collaborators and Investigators

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

Sponsor

Nantes University Hospital

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

November 1, 2014

Primary Completion (Actual)

May 1, 2015

Study Completion (Actual)

May 1, 2015

Study Registration Dates

First Submitted

August 11, 2016

First Submitted That Met QC Criteria

September 8, 2016

First Posted (Estimate)

September 9, 2016

Study Record Updates

Last Update Posted (Estimate)

September 9, 2016

Last Update Submitted That Met QC Criteria

September 8, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RC14_0213

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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