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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

48 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-03-01

Study Completion Date

2022-09-30

Brief Summary

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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).

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Detailed Description

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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.

Conditions

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Sedation Complication

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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IV DEX

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.

dexmedetomidine (IV)

Intervention Type DRUG

Administration of IV dexmedetomidine

IN DEX

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.

dexmedetomidine (IN)

Intervention Type DRUG

Administration of IN dexmedetomidine

Interventions

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dexmedetomidine (IV)

Administration of IV dexmedetomidine

Intervention Type DRUG

dexmedetomidine (IN)

Administration of IN dexmedetomidine

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

1 Month

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No