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

Azienda Ospedaliera di Padova48 enrolled

Overview

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).

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 Type

OBSERVATIONAL

Enrollment

Conditions

Sedation Complication

Interventions

Eligibility

Sex: ALLMin age: 1 MonthMax age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * children affected by behavioural disorders, who need sedation to perform EEG * American Society of Anaesthesiologists (ASA) status \< 3 * Written informed consent by a parent or legal guardian. Exclusion Criteria: * previous hypersensitivity reaction or contraindications to administration of DEX (cardiac failure, cardiac arrhythmias, long QT syndrome, bradycardia, hypotension, use of beta-blockers or digoxin, uncontrolled arterial hypertension, recent stroke or intracranial bleeding, Moya-Moya syndrome) * for IN administration, children with runny nose/mild respiratory infection

Outcomes

Primary Outcomes

efficacy (PSSS level 2)

the patient reaches the level 2 of the Pediatric Sedation State Scale

Time frame: 20 minutes after dexmedetomidine administration

Secondary Outcomes

safety (Sat > 90%; change < 25% of heart frequency and systemic pressure values)

presence of adverse events (desaturation, bradycardia, tachycardia, hypertension, hypotension)

Time frame: during the procedure