Effects of EMONO in Children During Dental Care (MEOPAeDent)

Multicentre, Prospective, Uncontrolled Study to Describe the Present, Felt and Sought Effects of EMONO in Children During Dental Care

The main objective of this project is to evaluate the effects sought and the effects felt by children when EMONO is used in pediatric dental care. The Investigators will try to characterize the children who have submitted a request to extend contact with EMONO. The maintenance of a framework for the safe use of this drug whose place in dental care is fundamental and the benefit ratio is very favorable is essential.

Study Overview

• Status: Completed
• Conditions: Dental Care
• Intervention / Treatment: Other: Non interventional study

Detailed Description

Some narcotic drugs and psychotropic drugs associated with a risk of misuse or identified dependence and are, moreover, the object of a reinforced surveillance. This is the case of EMONO (Equimolar Oxygen and Nitrogen Protoxide Mix), which is part of the ANSM (French National Agency for Medicines and Health Products Safety) list of drugs with enhanced surveillance. EMONO is a gas composed equally of oxygen and nitrous oxide (also called laughing gas). He has had a marketing authorization in France since 2001. Until 2009, it was reserved for hospital use. Since 2009, a modification of its MA has enabled the release of the hospital reserve, EMONO can now be used in city medicine and dental surgery. The ANSM has made its provision outside health facilities conditional on the implementation of a common national RMP, accompanied by a national monitoring of pharmacovigilance and addictovigilance. The latter is under the responsibility of CEIP-A of Nantes.

The use of EMONO in pediatric dental care is a particular mode of use in a pediatric population in which the administration of EMONO is often the first administration of a psychoactive substance known for its positive effects (euphoria). Health professionals daily observe children, who after care under EMONO, have a strong appetite for EMONO and claim for any intervention. It would be necessary to understand why, and to estimate the number of children involved. Do children feel positive effects during these actions, which could lead to a wish to prolong the contact with the gas, in search of an effect other than therapeutic? The main objective of this project is to evaluate the effects sought and the effects felt by children when EMONO is used in pediatric dental care. The investigators will try to characterize the children who have submitted a request to extend contact with EMONO. The maintenance of a framework for the safe use of this drug whose place in dental care is fundamental and the benefit ratio is very favorable is essential.

• Study Type: Observational
• Enrollment (Actual): 679

Contacts and Locations

Study Locations

• France
  • Nantes, France, 44093
    • 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: Probability Sample

Study Population

For this study we have therefore chosen to include all patients under 15 years of age seen for care under EMONO in the different participating DSCs. The use of EMONO in dental care is indicated for minor patients who are not cooperating in the dental care (doing not allow the realisation in the chair of care according to the acquired data of science) or who have a handicap limiting their cooperation. It applies during diagnostic or therapeutic consultations. The investigators will not include patients under 3 years of age as EMONO is much less effective below this age. All dental surgeons of the participating DSCs will be responsible for selecting patients who meet the inclusion criteria, offering selected patients and their parents to participate and include them in the study.

Description

Inclusion Criteria:

• Children aged 3 to 15, requiring care under MEOPA

Exclusion Criteria:

• Do not fit into the inclusion criteria

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Non interventional study	Other: Non interventional study; Non interventional study

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Description of the effects felt and sought after by EMONO during the first care session.	Exhaustive interview of patients about the presence or absence of each expected effect of EMONO and each adverse event at the first session of care; with also questioning the perception of this effect (positive or not).	Day 0

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assess the child's appreciation of the EMONO	VAS score of contact with EMONO	Day 0
Characterization of children who experience both analgesia and anxietyolysis	Choice of the child (inhalation of EMONO) with the minting tool test (drug-liking)	Day 0
Evaluate children's palatability for EMONO and characterize children with high palatability.	Composite criterion	Day 0
Evaluate the course of taking EMONO between the first and the last session of care	Evolution of the effective dose between the first and last treatment session	Month 1
Assess the impact of the difference in practice between the French University Hospitals on anxiety	Composite criterion	Day 0

Collaborators and Investigators

• Sponsor: Nantes University Hospital
• Collaborators: Agence Nationale de sécurité du Médicament

Publications and helpful links

General Publications

• Prud'homme T, Dajean-Trutaud S, Rousselet M, Feuillet F, Carpentier-Cheraud M, Bonnot O, Hyon I, Grall-Bronnec M, Lopez-Cazaux S, Victorri-Vigneau C. The MEOPAeDent trial protocol-an observational study of the Equimolar Mixture of Oxygen and Nitrous Oxide (EMONO) effects in paediatric dentistry. BMC Oral Health. 2019 Mar 7;19(1):42. doi: 10.1186/s12903-019-0732-6.

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 17, 2018
• Primary Completion (ACTUAL): June 24, 2020
• Study Completion (ACTUAL): June 24, 2020

Study Registration Dates

• First Submitted: February 26, 2018
• First Submitted That Met QC Criteria: March 2, 2018
• First Posted (ACTUAL): March 5, 2018

Study Record Updates

• Last Update Posted (ACTUAL): March 25, 2021
• Last Update Submitted That Met QC Criteria: March 24, 2021
• Last Verified: February 1, 2018

More Information

Terms related to this study

• Keywords: Substance-Related Disorders; Equimolar Mixture of Oxygen and Nitrous Oxide (EMONO)
• Other Study ID Numbers: RC17_0421

Drug and device information, study documents

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