Intranasal Dexmedetomidine for Sedated Hearing Testing
Condition: Auditory Brainstem Response
Study type: Interventional
Phase: Phase 3

Summary: 
      Auditory brainstem response testing is necessary in children who are not able to be tested by
      classical audiogram, because of their age or an associated retarded psycho-motor development
      or behavioral and cognitive troubles.

      This test needs a perfect immobility of the child, ideally being asleep. This situation is
      sometimes impossible to achieve in non-cooperative children.

      Currently, in the Pediatric Hospital of Nice, the investigators have to do a general
      anesthesia to perform quality auditory response tests in this kind of patients.

      The alternative to a general anesthesia would be a reliable sedative drug, allowing the
      performance of this diagnostic exam without the need of a hospitalization.

      Dexmedetomidine is a sedative drug with an action on the α2 adrenergic receptors. It causes a
      rapid sedation, similar to the natural sleep and with minimal secondary effects. The
      possibility of an intranasal administration, avoids the pain and discomfort of a venous
      access insertion.
    

Detailed description: 
      Auditory brainstem response testing is necessary in children who are not able to be tested by
      classical audiogram, because of their age or an associated retarded psycho-motor development
      or behavioral and cognitive troubles.

      This test needs a perfect immobility of the child, ideally being asleep. This situation is
      sometimes impossible to achieve in non-cooperative children.

      Currently, in the Pediatric Hospital of Nice, the investigators have to do a general
      anesthesia to perform quality auditory response tests in this kind of patients.

      The alternative to a general anesthesia would be a reliable sedative drug, allowing the
      performance of this diagnostic exam without the need of a hospitalization. An intranasal
      administration avoids the pain and discomfort of a venous access insertion.

      Dexmedetomidine is a sedative drug with an action on the α2 adrenergic receptors. It causes a
      rapid sedation, similar to the natural sleep and with minimal secondary effects. The
      treatment will be administrated by intranasal way at a dosage of 2,5µg/ kg in a single
      administration under continuous cardiorespiratory monitoring for 2 hours..

      The objective of this work is to evaluate the effectiveness of intranasal dexmedetomidine in
      the realization of the auditory brainstem response at the child with a cognitive or
      behavioral disorder

      This study will consist of research involving non-randomized, monocentric prospective
      interventional for a duration of 30 months. Patients from 1 year of age and under 16 years,
      in context of suspicion of deafness will be included. In view of active queue of
      otorhinolaryngology service of Nice University Hospital and taking into account lost sight,
      the investigators can include 60 patients, to have a representative sample of concerned
      pediatric population.

      The primary endpoint will be the rate of children included in the study who could determine
      the auditory threshold. The non-determination of this threshold (or the determination by
      resorting to general anesthesia or sedation of another type) regardless of the cause will be
      considered a failure.

      Despite the lack of specific protocols, the applications of dexmedetomidine in children for
      many diagnostic procedures have been studied in the past few years.

      Any prospective study about the efficacy of dexmedetomidine for auditory brainstem response
      testing has been yet conducted in children
    

Intervention name(s): Dexmedetomidine Hydrochloride
Intervention type(s): Drug
Intervention description(s): intranasal administration of 2.5µg/kg of dexmedetomidine to fall asleep the patients
Other intervention name(s): sedated auditory brainstem response
Intervention MeSH terms: Dexmedetomidine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic