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

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

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.

Study Overview

• Status: Completed
• Conditions: Dental Care for Children
• Intervention / Treatment: Behavioral: Evaluate the anxiolytic effect during dental care with MEOPA in children

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.

• Study Type: Observational
• Enrollment (Actual): 17

Contacts and Locations

Study Locations

• France
  • Nantes, France, 44000
    • CHU de Nantes

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 15 years (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Children from 3 to 15 years old, requiring MEOPA treatment with local anaesthesia for the first time

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluate the anxiolytic effect of EMONO in children during dental care	The primary endpoint will be a significant variation of heart rate at 3 key moments of the treatment session: Chair installation; 5 minutes after induction of MEOPA induction; The injection of the local anesthetic	15 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assess whether the child's stress is less intense after certain types of dental care under EMONO by the measure of heart rate variation.	The criterion for assessing the child's stress based on the care taken will be the significant variation in heart rate at another point in the treatment session: at the time of the end of the inhalation and care. Comparison will be made between children having pulptomy or extraction.	1 minute
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.	A Veerkamp Modified VENHAM Anxiety Assessment Scale will also be used before and after dental care ( from 0 to relaxed to 5 for extremely stressed) by the dentist. Comparison will also be made between chidren having pulpotomy or extraction.	1 minute

Collaborators and Investigators

• Sponsor: Nantes University Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 16, 2018
• Primary Completion (ACTUAL): January 30, 2019
• Study Completion (ACTUAL): January 30, 2019

Study Registration Dates

• First Submitted: May 28, 2019
• First Submitted That Met QC Criteria: June 24, 2019
• First Posted (ACTUAL): June 26, 2019

Study Record Updates

• Last Update Posted (ACTUAL): September 13, 2021
• Last Update Submitted That Met QC Criteria: September 10, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Keywords: Conscious sedation; Nitrous oxide; Paediatric dentistry
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Tranquilizing Agents; Psychotropic Drugs; Anti-Anxiety Agents
• Other Study ID Numbers: RC17_0275

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No