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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
| |
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| dexmedetomidine (IV) | Drug | Administration of IV dexmedetomidine |
| |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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children affected by behavioural disorders
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital of Padova | Padova | 35128 | Italy |
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| ID | Term |
|---|---|
| D020927 | Dexmedetomidine |
| ID | Term |
|---|---|
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| dexmedetomidine (IN) |
| Drug |
Administration of IN dexmedetomidine |
|