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

• Status: Completed
• Trial end date: 2019-09-28
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Azienda Ospedaliera di Padova
• Treatments: Dexmedetomidine

Criteria

Inclusion Criteria:

• children affected by behavior disorders who underwent EEG procedure with sedation

• written informed consent

Exclusion Criteria:

• ASA > 2

• hypersensitivity of active substance

• therapy with beta blockers or digoxin, arrhythmia