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

Sedation Complication Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06434428
• Other study ID #: AO/18/4422
• Status: Completed
• Start date: March 1, 2018
• Est. completion date: September 30, 2022

Study information

• Verified date: May 2024
• Source: Azienda Ospedaliera di Padova
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: September 30, 2022
• Est. primary completion date: August 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Month to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Mental Disorders
• Sedation Complication

Intervention

Drug:
• dexmedetomidine (IV)
Administration of IV dexmedetomidine
• dexmedetomidine (IN)
Administration of IN dexmedetomidine

Locations

Country	Name	City	State
Italy	University Hospital of Padova	Padova

Sponsors (1)

Lead Sponsor	Collaborator
Azienda Ospedaliera di Padova

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	efficacy (PSSS level 2)	the patient reaches the level 2 of the Pediatric Sedation State Scale	20 minutes after dexmedetomidine administration
Secondary	safety (Sat > 90%; change < 25% of heart frequency and systemic pressure values)	presence of adverse events (desaturation, bradycardia, tachycardia, hypertension, hypotension)	during the procedure