Effects of EMONO in Children During Dental Care

Dental Care Clinical Trial

— MEOPAeDent  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03453411
• Other study ID #: RC17_0421
• Status: Completed
• Start date: May 17, 2018
• Est. completion date: June 24, 2020

Study information

• Verified date: February 2018
• Source: Nantes University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 679
• Est. completion date: June 24, 2020
• Est. primary completion date: June 24, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 15 Years

Eligibility

Inclusion Criteria:

• Children aged 3 to 15, requiring care under MEOPA

Exclusion Criteria:

• Do not fit into the inclusion criteria

Related Conditions & MeSH terms

• Dental Care

Intervention

Other:
• Non interventional study
Non interventional study

Locations

Country	Name	City	State
France	Chu de Nantes	Nantes

Sponsors (2)

Lead Sponsor	Collaborator
Nantes University Hospital	Agence Nationale de sécurité du Médicament

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Assess the child's appreciation of the EMONO	VAS score of contact with EMONO	Day 0
Secondary	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
Secondary	Evaluate children's palatability for EMONO and characterize children with high palatability.	Composite criterion	Day 0
Secondary	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
Secondary	Assess the impact of the difference in practice between the French University Hospitals on anxiety	Composite criterion	Day 0