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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03453411
Other study ID # RC17_0421
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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