## Protocol Section
### Identification Module
**NCT ID:** NCT06434428

**Brief Title:** Comparison Between Intranasal vs Intravenous Dexmedetomidine for EEG Sedation of Children With Behavior Disorders.

**Official Title:** Comparison Between Intranasal Versus Intravenous Administration of Dexmedetomidine for EEG in Children With Behavior Disorders

#### Organization Study ID Info
**ID:** AO/18/4422
#### Organization
**Class:** OTHER
**Full Name:** Azienda Ospedaliera di Padova
### Status Module
#### Completion Date
**Date:** 2022-09-30

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-30

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-28

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2021-08-30

**Type:** ACTUAL

#### Start Date
**Date:** 2018-03-01

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-23
**Study First Submit QC Date:** 2024-05-28
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Azienda Ospedaliera di Padova

#### Responsible Party

**Investigator Affiliation:** Azienda Ospedaliera di Padova

**Investigator Full Name:** angela amigoni

**Investigator Title:** Head of the Pediatric Intensive Care Unit

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**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).

**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.

### Conditions Module

**Conditions:**

- Sedation Complication

**Keywords:**

- sedation

- dexmedetomidine

- safety

### Design Module

#### Design Info

**Observational Model:** COHORT

**Time Perspective:** PROSPECTIVE

#### Enrollment Info

**Count:** 48

**Type:** ACTUAL

**Study Type:** OBSERVATIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** 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.

**Intervention Names:**

- Drug: dexmedetomidine (IV)

**Label:** IV DEX

#### Arm Group 2

**Description:** 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.

**Intervention Names:**

- Drug: dexmedetomidine (IN)

**Label:** IN DEX

### Interventions

#### Intervention 1

**Arm Group Labels:**

- IV DEX

**Description:** Administration of IV dexmedetomidine

**Name:** dexmedetomidine (IV)

**Type:** DRUG

#### Intervention 2

**Arm Group Labels:**

- IN DEX

**Description:** Administration of IN dexmedetomidine

**Name:** dexmedetomidine (IN)

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Description:** the patient reaches the level 2 of the Pediatric Sedation State Scale

**Measure:** efficacy (PSSS level 2)

**Time Frame:** 20 minutes after dexmedetomidine administration

#### Secondary Outcomes

**Description:** presence of adverse events (desaturation, bradycardia, tachycardia, hypertension, hypotension)

**Measure:** safety (Sat > 90%; change < 25% of heart frequency and systemic pressure values)

**Time Frame:** during the procedure

### Eligibility Module

**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

**Maximum Age:** 18 Years

**Minimum Age:** 1 Month

**Sampling Method:** NON_PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- CHILD

- ADULT

**Study Population:** children affected by behavioural disorders

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Padova

**Country:** Italy

**Facility:** University Hospital of Padova

**Zip:** 35128

### IPD Sharing Statement Module

**IPD Sharing:** UNDECIDED

## Derived Section

### Condition Browse Module - Browse Branches

- Abbrev: BXM

- Name: Behaviors and Mental Disorders

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M4815

- Name: Mental Disorders

- Relevance: HIGH

- As Found: Behavior Disorder

- ID: M14473

- Name: Psychotic Disorders

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000001523

- Term: Mental Disorders

### Intervention Browse Module - Ancestors

- ID: D000006993

- Term: Hypnotics and Sedatives

- ID: D000002492

- Term: Central Nervous System Depressants

- ID: D000045505

- Term: Physiological Effects of Drugs

- ID: D000018712

- Term: Analgesics, Non-Narcotic

- ID: D000000700

- Term: Analgesics

- ID: D000018689

- Term: Sensory System Agents

- ID: D000018373

- Term: Peripheral Nervous System Agents

- ID: D000058647

- Term: Adrenergic alpha-2 Receptor Agonists

- ID: D000000316

- Term: Adrenergic alpha-Agonists

- ID: D000000322

- Term: Adrenergic Agonists

- ID: D000018663

- Term: Adrenergic Agents

- ID: D000018377

- Term: Neurotransmitter Agents

- ID: D000045504

- Term: Molecular Mechanisms of Pharmacological Action

### Intervention Browse Module - Browse Branches

- Abbrev: Analg

- Name: Analgesics

- Abbrev: CNSDep

- Name: Central Nervous System Depressants

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M22662

- Name: Dexmedetomidine

- Relevance: HIGH

- As Found: Twice daily

- ID: M10043

- Name: Hypnotics and Sedatives

- Relevance: LOW

- As Found: Unknown

- ID: M4032

- Name: Analgesics

- Relevance: LOW

- As Found: Unknown

- ID: M20786

- Name: Analgesics, Non-Narcotic

- Relevance: LOW

- As Found: Unknown

- ID: M20746

- Name: Adrenergic Agents

- Relevance: LOW

- As Found: Unknown

- ID: M3668

- Name: Adrenergic alpha-Agonists

- Relevance: LOW

- As Found: Unknown

- ID: M3673

- Name: Adrenergic Agonists

- Relevance: LOW

- As Found: Unknown

- ID: M20504

- Name: Neurotransmitter Agents

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: D000020927

- Term: Dexmedetomidine

### Misc Info Module

- Version Holder: 2024-05-31
