Ignite Creation Date:
2024-06-16 @ 11:49 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06434428
Status:
COMPLETED
Last Update Posted:
2024-05-30
First Post:
2024-05-23
Brief Title:
Comparison Between Intranasal vs Intravenous Dexmedetomidine for EEG Sedation of Children With Behavior Disorders
Sponsor:
Azienda Ospedaliera di Padova
Organization:
Azienda Ospedaliera di Padova
Study Overview
Official Title:
Comparison Between Intranasal Versus Intravenous Administration of Dexmedetomidine for EEG in Children With Behavior Disorders
Status:
COMPLETED
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None