drugset / Trial / NCT03799783

The Use of Dexmedetomidine for EEG Sedation in Children With Behavioural Disorders

NCT03799783

Phase 2 Completed 19 enrolled Azienda Ospedaliera di Padova
NaSingle-groupOpen-labelTreatment

Summary

Children's compliance during diagnostic or therapeutic procedures is a challenge, often requiring the use of sedative and/or analgesic drugs. Electroencephalogram (EEG) needs stillness for a medium-long period but, at the same time, the use of any drug for sedation may affect the exam through an interference with EEG waves. Dexmedetomidine is a selective ∝2-adrenergic agonist with sedative and anxiolytic properties, with a long effect and which does not alter EEG pattern. The aim of this interventional study is to evaluate the effectiveness, safety and feasibility of dexmedetomidine for sedation during EEG in children who are not cooperative. Children affected by behavioral disorders and requiring sedation to perform EEG were considered. The protocol establishes to administer IV dexmedetomidine (loading dose and continued infusion) to reach a targeted level of sedation (Pediatric Sedation State Scale = 2). Vital signs (SatO2, RR, EtCO2, HR, BP) and level of sedation are recorded before, during and after procedure until the offset.

Timeline

Start
2018-03-01
Primary completion
2019-02-28
Completion
2019-09-28

Publications

Drugs

EvaluationDrugModalityDoseRoute
Subject Dexmedetomidine Other / unclassified 1 ug/kg Intravenous