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Comparison Between Intranasal vs Intravenous Dexmedetomidine for EEG Sedation of Children With Behavior Disorders.

Sedation Complication Clinical Trial

Official title:
Comparison Between Intranasal Versus Intravenous Administration of Dexmedetomidine for EEG in Children With Behavior Disorders

Clinical Trial Summary

The aim of the project was to compare the efficacy and safety of intranasal (IN) and intravenous (IV) dexmedetomidine (DEX) in procedural sedation for electroencephalogram (EEG) in pediatric patients with behavioural disorders. Single-centre comparative observational study in the tertiary care centre of Padua, regarding all consecutive pediatric patients affected by behavioural disorders, who needed sedation for EEG recording. A group of children received IV administration of DEX, the following year a second group of children received IN administration of the same drug. Target of sedation was level 2, according to the Paediatric Sedation State Scale (PSSS).

Clinical Trial Description

OBJECTIVE: The aim of the project was to compare the efficacy and safety of intranasal (IN) and intravenous (IV) dexmedetomidine (DEX) in procedural sedation for electroencephalogram (EEG) in pediatric patients with behavioural disorders. METHODS: Single-centre comparative observational study in the tertiary care centre of Padua, regarding all consecutive patients < 18 years old affected by behavioural disorders, who needed sedation for EEG recording. From 2018 to 2020 a group of children received IV administration of DEX (IV DEX), the following year a second group of children received IN administration of the same drug (IN DEX). In both groups, target of sedation was level 2, according to the Paediatric Sedation State Scale (PSSS). Heart rate (HR), pulse oxygen saturation and blood pressure (BP) were registered. EEG recording quality and caregivers' satisfaction were collected. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06434428
Study type Observational
Source Azienda Ospedaliera di Padova
Contact
Status Completed
Phase
Start date March 1, 2018
Completion date September 30, 2022
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