Clinical trial NCT03453411: Effects of EMONO in Children During Dental Care
Official title: Multicentre, Prospective, Uncontrolled Study to Describe the Present, Felt and Sought Effects of EMONO in Children During Dental Care
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Dental Care
Keywords: Equimolar Mixture of Oxygen and Nitrous Oxide (EMONO)
Substance-Related Disorders
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
Collaborators: name: Agence Nationale de sécurité du Médicament
First posted: 2018-03-05
Enrollment: 679
Sex: ALL
Minimum age (years): 3
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: Inclusion Criteria:

* Children aged 3 to 15, requiring care under MEOPA

Exclusion Criteria:

* Do not fit into the inclusion criteria

Primary outcomes:
measure: Description of the effects felt and sought after by EMONO during the first care session.
timeFrame: Day 0
Secondary outcomes:
measure: Assess the child's appreciation of the EMONO
timeFrame: Day 0
measure: Characterization of children who experience both analgesia and anxietyolysis
timeFrame: Day 0
measure: Evaluate children's palatability for EMONO and characterize children with high palatability.
timeFrame: Day 0
measure: Evaluate the course of taking EMONO between the first and the last session of care
timeFrame: Month 1
measure: Assess the impact of the difference in practice between the French University Hospitals on anxiety
timeFrame: Day 0
Other outcomes:
Locations:
city: Nantes
country: France
facility: Chu de Nantes
Study officials:
affiliation: Nantes University Hospital
name: Tony Prud'homme, Dr
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.