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

NCT06434428 | Completed

• 1 other identifier: AO/18/4422
• Study Type: observational
• Target: 48
• Locations: 1 country
• Sites: 1

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).

Conditions

Sedation Complication

Keywords

sedation; dexmedetomidine; safety

Outcome Measures

Primary Outcomes (1)

• efficacy (PSSS level 2)

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

  20 minutes after dexmedetomidine administration

Secondary Outcomes (1)

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

  during the procedure

Study Arms (2)

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.

Drug: dexmedetomidine (IV)

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.

Drug: dexmedetomidine (IN)

Interventions

dexmedetomidine (IV) DRUG

Administration of IV dexmedetomidine

IV DEX

dexmedetomidine (IN) DRUG

Administration of IN dexmedetomidine

IN DEX

Eligibility Criteria

• Age: 1 Month - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

children affected by behavioural disorders

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Azienda Ospedaliera di Padova: lead

Study Sites (1)

University Hospital of Padova

Padua, 35128, Italy

Location

MeSH Terms

Interventions

Dexmedetomidine

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of the Pediatric Intensive Care Unit

Study Record Dates

• First Submitted: May 23, 2024
• First Posted: May 30, 2024
• Study Start: March 1, 2018
• Primary Completion: August 30, 2021
• Study Completion: September 30, 2022
• Last Updated: May 30, 2024

Record last verified: 2024-05

Locations

IT (1)