Phase 2
N=19
The Use of Dexmedetomidine for EEG Sedation in Children With Behavioural Disorders
Procedural Sedation · Behavior Disorders
Bottom Line
View on ClinicalTrials.gov: NCT03799783 ↗Enrolled (actual)
19
Serious AEs
0.0%
Results posted
Jan 2021
Primary outcome: Primary: Number of Patients That Reach a Score Equal or Lower Than 2 Ten Minutes After the Infusion of Dexmedetomidine (Assessed With the PSSS Pediatric Sedation State Scale) — 13 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- dexmedetomidine (Drug)
- Age
- Pediatric, Adult · 0+ yrs
- Sex
- All
- Sponsor
- Azienda Ospedaliera di Padova
- Primary completion
- Feb 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Patients That Reach a Score Equal or Lower Than 2 Ten Minutes After the Infusion of Dexmedetomidine (Assessed With the PSSS Pediatric Sedation State Scale) |
13 | — |
| SECONDARY Number of Patients With Adverse Events |
10 | — |
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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT03799783). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.