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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06434428

Enrollment

Registered

2024-05-30

Start date

2018-03-01

Completion date

2022-09-30

Last updated

2024-05-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sedation Complication

Keywords

sedation, dexmedetomidine, safety

Brief 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).

Detailed 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.

Interventions

DRUGdexmedetomidine (IV)

Administration of IV dexmedetomidine

DRUGdexmedetomidine (IN)

Administration of IN dexmedetomidine

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

1 Months to 18 Years

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

Design outcomes

Primary

Measure	Time frame	Description
efficacy (PSSS level 2)	20 minutes after dexmedetomidine administration	the patient reaches the level 2 of the Pediatric Sedation State Scale

Secondary

Measure	Time frame	Description
safety (Sat > 90%; change < 25% of heart frequency and systemic pressure values)	during the procedure	presence of adverse events (desaturation, bradycardia, tachycardia, hypertension, hypotension)

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026