Clinical trial NCT03998774: Evaluation Ofe the Anxiolytic Effect of EMONO in Children During Dental Care (MOPEA)
Official title: Uncontrolled Prospective Monocentric Study Aiming to Evaluate the Anxiolytic Effect of EMONO in Children During Dental Care
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Dental Care for Children
Keywords: Nitrous oxide
Conscious sedation
Paediatric dentistry
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
First posted: 2019-06-26
Enrollment: 17
Sex: ALL
Minimum age (years): 3
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children from 3 to 15 years old, requiring MEOPA treatment with local anaesthesia for the first time

Brief 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.

Detailed description: The EquiMolar Oxygen and Nitrous Oxide 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. It has had a marketing authorization in France since 2001. Until 2009, it was reserved for hospital use and emergency vehicles; and indicated in the analgesia of short-term painful acts or during medical assistance. urgency in adults and children, dental sedation in children and frail subjects, and obstetrics. The actual benefit was considered important by the Transparency Committee.

Since 2009, a modification of the MAH for EMONO-based specialties has authorized their release from the hospital reserve, which can now be issued for professional use in city and dental surgery. Given the risks associated with the use of EMONO, in particular its potential for abuse and dependence, the ANSM conditioned its availability outside health facilities to the implementation of a common national RMP. This measure was also accompanied by a national monitoring of pharmacovigilance and addictovigilance. The latter is under the responsibility of CEIP-A of Nantes.

The University Hospital of Nantes is currently conducting a general evaluation of the use of EMONO 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 EMONO in children in the Dental Care Center. This analysis follows a previous study (MEOPAeDent) that subjectively took into account this anxiolysis.

The analysis of this study will allow us to improve the good use of MEOPA for dental care.

Eligibility criteria: 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.

Primary outcomes:
measure: Evaluate the anxiolytic effect of EMONO in children during dental care
timeFrame: 15 minutes
Secondary outcomes:
measure: Assess whether the child's stress is less intense after certain types of dental care under EMONO by the measure of heart rate variation.
timeFrame: 1 minute
measure: Assess whether the child's stress is less intense after certain types of dental care under EMONO by the measure Veerkamp Modified VENHAM Anxiety Assessment Scale.
timeFrame: 1 minute
Other outcomes:
Locations:
city: Nantes
country: France
facility: Chu de Nantes
Study officials:
affiliation: Nantes University Hospital
name: Tony Prud'homme
role: PRINCIPAL_INVESTIGATOR
References: