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

University of Padua

Status: Completed

Conditions: Sedation Complication

Treatments: Drug: dexmedetomidine (IV); Drug: dexmedetomidine (IN)

Study type: Observational

Funder types: Other

Identifiers

NCT06434428

AO/18/4422

Details and patient eligibility

About

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).

Full 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.

Enrollment: 48 patients

Sex: All

Ages: 1 month to 18 years old

Volunteers: No Healthy Volunteers

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

Trial design

48 participants in 2 patient groups

IV DEX

Description:

Patients treated intravenously receives a bolus of DEX (2 mcg/kg over ten minutes), followed by continuous infusion (1-2 mcg/kg/hour), stopped at the end of the procedure. The bolus could be repeated up to three times to reach the optimal target level of sedation before starting the continuous infusion.

Treatment:

Drug: dexmedetomidine (IV)

IN DEX

Description:

For the IN administration, after a first bolus of 4 mcg/kg it is possible to repeat boluses of 1-2mcg/kg of DEX (maximum dose for each administration is 200mcg). The drug dose is divided into two equal aliquots, with one aliquot administered into each nostril by a nurse using an atomizer device.

Treatment:

Drug: dexmedetomidine (IN)