NCT03998774

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

Uncontrolled Prospective Monocentric Study Aiming to Evaluate the Anxiolytic Effect of EMONO in Children During Dental Care

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 17 (actual)
• Sponsor: Nantes University Hospital · Academic / Other
• Sex: All
• Age: 3 Years – 15 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Dental Care for Children

Interventions

Type	Name	Description
BEHAVIORAL	Evaluate the anxiolytic effect during dental care with MEOPA in children	Primary Purpose: The main objective of this study is to evaluate the anxiolytic effect of EMONO in children during dental care. Enrollment: 30

Timeline

• Start date: 2018-03-16
• Primary completion: 2019-01-30
• Completion: 2019-01-30
• First posted: 2019-06-26
• Last updated: 2021-09-13

Locations

1 site across 1 country: France