Effects of EMONO in Children During Dental Care
Condition: Dental Care
Study type: Observational

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.
    

Intervention name(s): Non interventional study
Intervention type(s): Other
Intervention description(s): Non interventional study
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.
      
Keywords: Equimolar Mixture of Oxygen and Nitrous Oxide (EMONO); Substance-Related Disorders