- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02894463
Study Aimed at Detecting Potential Abuse of Nitrous Oxide in Children During Dental Care (MEOPAeDent)
Uncontrolled Prospective Single-center Study Aimed at Detecting Potential Abuse of Nitrous Oxide in Children During Dental Care
Study Overview
Detailed Description
Study Type
Enrollment (Actual)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
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
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
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
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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