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

NCT03799783 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 19

Last updated 2021-02-02

Study results available
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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.

Conditions

  • Procedural Sedation
  • Behavior Disorders

Interventions

DRUG

dexmedetomidine

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

Sponsors & Collaborators

  • Azienda Ospedaliera di Padova

    lead OTHER

Principal Investigators

  • angela amigoni, MD · azienda Ospedaliera di Padova-Pediatric Intensive Care Unit

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
1 Month
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

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

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03799783 on ClinicalTrials.gov