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

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ClinicalTrials.gov Identifier: NCT02894463
Recruitment Status : Completed
First Posted : September 9, 2016
Last Update Posted : September 9, 2016
Sponsor:
Information provided by (Responsible Party):
Nantes University Hospital

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

Condition or disease Intervention/treatment
Periodontal Disease Other: questionnaire

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
Actual Enrollment : 76 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Uncontrolled Prospective Single-center Study Aimed at Detecting Potential Abuse of Nitrous Oxide in Children During Dental Care
Study Start Date : November 2014
Actual Primary Completion Date : May 2015
Actual Study Completion Date : May 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dental Health




Primary Outcome Measures :
  1. 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



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Ages Eligible for Study:   3 Years to 15 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Criteria

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02894463


Sponsors and Collaborators
Nantes University Hospital
Investigators
Principal Investigator: Tony Prud'homme, Dr Nantes University Hospital

Responsible Party: Nantes University Hospital
ClinicalTrials.gov Identifier: NCT02894463     History of Changes
Other Study ID Numbers: RC14_0213
First Posted: September 9, 2016    Key Record Dates
Last Update Posted: September 9, 2016
Last Verified: August 2016

Keywords provided by Nantes University Hospital:
dental care
emeno
abuse

Additional relevant MeSH terms:
Periodontal Diseases
Gingival Diseases
Mouth Diseases
Stomatognathic Diseases
Nitrous Oxide
Anesthetics, Inhalation
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents