CompletedNot Applicable

Evaluation Ofe the Anxiolytic Effect of EMONO in Children During Dental Care (MOPEA)

France17 participantsStarted 2018-03-16

Plain-language summary

The EquiMolar Oxygen and Nitrous Oxyde mix (EMONO) is listed by the ANSM (National Agency for the Safety of Medicines and Health Products) as drugs with enhanced surveillance. EMONO is a gas composed equally of oxygen and nitrous oxide, presented in bottle. The University Hospital of Nantes is currently conducting a general evaluation of the EMONO use in the hospital context. The department of odontology is part of this movement and wants to study the anxiolytic effect expected during dental care under MEOPA in children in the Dental Care Center. This analysis follows a previous study (MEOPAeDent) that subjectively took into account this anxiolysis.

Who can participate

Age range3 Years – 15 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Children from 3 to 15 years, * Requiring dental treatment under EMONO including local anesthesia * Not opposed, as well as parents, to participate in the study * Having a sufficiently cooperative attitude to allow the installation of the monitoring equipment * The use of EMONO for dental care must be a first time for the child Exclusion Criteria: * The excluded patients will be those whose number of care is too important, justifying a general anesthesia. Similarly, patients who do not require anesthesia for their care will be excluded.

What they're measuring

Evaluate the anxiolytic effect of EMONO in children during dental care

Timeframe: 15 minutes

Trial details

NCT IDNCT03998774

SponsorNantes University Hospital

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2019-01-30

View on ClinicalTrials.gov More Dental Care for Children trials