Evaluation Ofe the Anxiolytic Effect of EMONO in Children During Dental Care (MOPEA)
Condition: Dental Care for Children
Study type: Observational [Patient Registry]

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.
    

Intervention name(s): Evaluate the anxiolytic effect during dental care with MEOPA in children
Intervention type(s): Behavioral
Intervention description(s): Primary Purpose: The main objective of this study is to evaluate the anxiolytic effect of EMONO in children during dental care.
Enrollment: 30
Intervention MeSH terms: Anti-Anxiety Agents
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
      
Keywords: Nitrous oxide; Conscious sedation; Paediatric dentistry