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

NCT03998774 | Completed

• 1 other identifier: RC17_0275
• Study Type: observational
• Target: 17
• Locations: 1 country
• Sites: 1

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.

Conditions

Dental Care for Children

Keywords

Nitrous oxide; Conscious sedation; Paediatric dentistry

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Assess whether the child's stress is less intense after certain types of dental care under EMONO by the measure of heart rate variation.

  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.

  1 minute

Interventions

Evaluate the anxiolytic effect during dental care with MEOPA in children BEHAVIORAL

Primary Purpose: The main objective of this study is to evaluate the anxiolytic effect of EMONO in children during dental care. Enrollment: 30

Eligibility Criteria

• Age: 3 Years - 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Nantes University Hospital: lead

Study Sites (1)

Chu de Nantes

Nantes, 44000, France

Location

MeSH Terms

Interventions

Meopa

Study Officials

• Tony Prud'homme

  Nantes University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 28, 2019
• First Posted: June 26, 2019
• Study Start: March 16, 2018
• Primary Completion: January 30, 2019
• Study Completion: January 30, 2019
• Last Updated: September 13, 2021

Record last verified: 2021-09

Locations

FR (1)