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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06434428
Other study ID # AO/18/4422
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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