Effects of EMONO in Children During Dental Care

Completed

• Conditions: Dental Care
• Interventions: Other: Non interventional study

• Registration Number: NCT03453411
• Lead Sponsor: Nantes University Hospital

Brief Summary

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.

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Status Verified: 2018-02
• Study First Submitted: 2018-02-26
• Study First Submitted QC: 2018-03-02
• Study First Posted: 2018-03-05
• Study Start: 2018-05-17
• Primary Completion: 2020-06-24
• Study Completion: 2020-06-24
• Last Update Submitted: 2021-03-24
• Last Update Posted: 2021-03-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 679

Inclusion Criteria

• Children aged 3 to 15, requiring care under MEOPA

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Exclusion Criteria

• Do not fit into the inclusion criteria

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Non interventional study	Non interventional study	-

Primary Outcome Measures

Name	Time	Method
Description of the effects felt and sought after by EMONO during the first care session.	Day 0	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).

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Chu de Nantes; 🇫🇷 Nantes, France