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

Dental Care for Children Clinical Trial

— MOPEA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03998774
• Other study ID #: RC17_0275
• Status: Completed
• Start date: March 16, 2018
• Est. completion date: January 30, 2019

Study information

• Verified date: September 2021
• Source: Nantes University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: January 30, 2019
• Est. primary completion date: January 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 15 Years

Eligibility

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.

Related Conditions & MeSH terms

• Dental Care for Children

Intervention

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

Locations

Country	Name	City	State
France	Chu de Nantes	Nantes

Sponsors (1)

Lead Sponsor	Collaborator
Nantes University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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