Clinical trial

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

Name
AO/18/4422
Description
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).
Trial arms
Trial start
2018-03-01
Estimated PCD
2021-08-30
Trial end
2022-09-30
Status
Completed
Treatment
dexmedetomidine (IV)
Administration of IV dexmedetomidine
Arms:
IV DEX
dexmedetomidine (IN)
Administration of IN dexmedetomidine
Arms:
IN DEX
Size
48
Primary endpoint
efficacy (PSSS level 2)
20 minutes after dexmedetomidine administration
Eligibility criteria
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
Protocol
{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'COHORT', 'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'count': 48, 'type': 'ACTUAL'}}
Updated at
2024-05-30

1 organization

1 product

1 indication