drugset / Trial / NCT03530371

Intranasal Dexmedetomidine for Sedated Hearing Testing

NCT03530371

Phase 3 Completed 60 enrolled Fondation Lenval
NaSingle-groupOpen-labelDiagnostic

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.

Timeline

Start
2019-05-02
Primary completion
2021-11-16
Completion
2021-12-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Dexmedetomidine Other / unclassified 2.5 ug/kg Intranasal

Indications

No indication recorded.