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Completed

NCT Number: NCT06434428

Comparison Between Intranasal vs Intravenous Dexmedetomidine for EEG Sedation of Children With Behavior Disorders.

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).

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Key information

Age range

1 month–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital of Padova

Padova, 35128, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

dexmedetomidine (IV)

Drug

Administration of IV dexmedetomidine

dexmedetomidine (IN)

Drug

Administration of IN dexmedetomidine

Primary outcomes

  1. efficacy (PSSS level 2)

    Time frame: 20 minutes after dexmedetomidine administration

    the patient reaches the level 2 of the Pediatric Sedation State Scale

Secondary outcomes

  1. safety (Sat > 90%; change < 25% of heart frequency and systemic pressure values)

    Time frame: during the procedure

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

Sponsors and collaborators

Lead sponsor

Azienda Ospedaliera di Padova

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2021
Study completion
2022
First posted
May 30, 2024
Registry last updated
May 30, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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