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

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).

Study Overview

• Status: Completed
• Conditions: Sedation Complication
• Intervention / Treatment: Drug: dexmedetomidine (IV); Drug: dexmedetomidine (IN)

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.

• Study Type: Observational
• Enrollment (Actual): 48

Contacts and Locations

Study Locations

• Italy
  • Padova, Italy, 35128
    • University Hospital of Padova

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

children affected by behavioural disorders

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Drug: dexmedetomidine (IV); 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.	Drug: dexmedetomidine (IN); Administration of IN dexmedetomidine

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Azienda Ospedaliera di Padova

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2018
• Primary Completion (Actual): August 30, 2021
• Study Completion (Actual): September 30, 2022

Study Registration Dates

• First Submitted: May 23, 2024
• First Submitted That Met QC Criteria: May 28, 2024
• First Posted (Actual): May 30, 2024

Study Record Updates

• Last Update Posted (Actual): May 30, 2024
• Last Update Submitted That Met QC Criteria: May 28, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: safety; dexmedetomidine; sedation
• Additional Relevant MeSH Terms: Mental Disorders; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Non-Narcotic; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Hypnotics and Sedatives; Dexmedetomidine
• Other Study ID Numbers: AO/18/4422

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No