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Completed

NCT Number: NCT03453411

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.

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Key information

Conditions

Dental Care Chemically-Induced Disorders Mental Disorders Substance-Related Disorders

Age range

3 year–15 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Chu de Nantes

Nantes, 44093, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Children aged 3 to 15, requiring care under MEOPA

Exclusion criteria

  • Do not fit into the inclusion criteria

Treatment and study plan

Non interventional study

Other

Non interventional study

Primary outcomes

  1. Description of the effects felt and sought after by EMONO during the first care session.

    Time frame: 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 outcomes

  1. Assess the child's appreciation of the EMONO

    Time frame: Day 0

    VAS score of contact with EMONO

  2. Characterization of children who experience both analgesia and anxietyolysis

    Time frame: Day 0

    Choice of the child (inhalation of EMONO) with the minting tool test (drug-liking)

  3. Evaluate children's palatability for EMONO and characterize children with high palatability.

    Time frame: Day 0

    Composite criterion

  4. Evaluate the course of taking EMONO between the first and the last session of care

    Time frame: Month 1

    Evolution of the effective dose between the first and last treatment session

  5. Assess the impact of the difference in practice between the French University Hospitals on anxiety

    Time frame: Day 0

    Composite criterion

Sponsors and collaborators

Lead sponsor

Nantes University Hospital

Other

Collaborators

  • Agence Nationale de sécurité du Médicament

Registry information

Official study title

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

Acronym: MEOPAeDent

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Mar 5, 2018
Registry last updated
Mar 25, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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