The Use of Dexmedetomidine for EEG Sedation in Children With Behavioural Disorders
Condition: Procedural Sedation; Behavior Disorders
MeSH terms: Mental Disorders
Study type: Interventional
Phase: Phase 2

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.
    

Detailed description: 
      Compliance during diagnostic or therapeutic procedures is a very frequent challenge in
      children. Procedural sedation and analgesia represents an effective answer to this problem.
      Electroencephalogram (EEG) is a procedure which needs stillness for a medium-long period.
      Whereas the majority of children carry out this procedure without sedation, patients with
      behavioral problems, who frequently need to rule out the presence of seizures as associated
      symptoms or different disease, often show an insufficient compliance. Sedative drugs usually
      interfere with EEG cerebral waves pattern, so they can not be used. Dexmedetomidine is a
      selective ∝2-adrenergic agonist with prevalent sedative and anxiolytic properties, with a
      long effect and which does not alter EEG pattern.

      The aim of this interventional study is to evaluate effectiveness, safety and feasibility of
      dexmedetomidine for sedation during EEG in children who are not cooperative.

      Children referred to the Pediatric Neurology Department of the Pediatric Hospital of Padova
      and required sedation to perform EEG were considered in the study.

      The protocol establishes to administer dexmedetomidine IV 2 μg/kg in 10 minutes (loading
      dose) followed by continuous infusion at a rate of 1 μg/kg/h until procedure was complete.
      The loading dose can be repeated up to two times, if needed, to achieve the targeted level of
      Pediatric Sedation State Scale (PSSS) of 2 (quiet, asleep or awake, not moving during
      procedure, and no frown or brow furrow indicating pain or anxiety, no verbalization of any
      complaint). Vital signs (SatO2, RR, EtCO2, HR, BP) and level of sedation are recorded before,
      during and after procedure until the complete awake of the patient. The quality of the EEG
      pattern was also evaluated. Occurrence and type of adverse events are registered during this
      period. Finally, the caregivers' opinion about the quality of the sedation and the presence
      of any sleep disturbance at home during the next 12 hours after the procedure were
      considered.
    

Intervention name(s): dexmedetomidine
Intervention type(s): Drug
Intervention description(s): To administer dexmedetomidine IV 2 μg/kg in 10 minutes (loading dose) followed by continuous infusion at a rate of 1 μg/kg/h until procedure was complete
Other intervention name(s): dexdor
Intervention MeSH terms: Dexmedetomidine
Intervention model: Single Group Assignment
Intervention model description: Drug administration by a loading dose followed by continuous infusion during a procedure
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: dexmedetomidine; sedation