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Completed

NCT Number: NCT03799783

The Use of Dexmedetomidine for EEG Sedation in Children With Behavioural Disorders

Children's compliance during diagnostic or therapeutic procedures is a challenge, often requiring the use of sedative and/or analgesic drugs.

Electroencephalogram (EEG) needs stillness for a medium-long period but, at the same time, the use of any drug for sedation may affect the exam through an interference with EEG waves. Dexmedetomidine is a selective ∝2-adrenergic agonist with sedative and anxiolytic properties, with a long effect and which does not alter EEG pattern.

The aim of this interventional study is to evaluate the effectiveness, safety and feasibility of dexmedetomidine for sedation during EEG in children who are not cooperative.

Children affected by behavioral disorders and requiring sedation to perform EEG were considered. The protocol establishes to administer IV dexmedetomidine (loading dose and continued infusion) to reach a targeted level of sedation (Pediatric Sedation State Scale = 2). Vital signs (SatO2, RR, EtCO2, HR, BP) and level of sedation are recorded before, during and after procedure until the offset.

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Key information

Conditions

Procedural Sedation Behavior Disorders Mental Disorders

Age range

1 month–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Pediatric Intensive Care Unit - Department of Woman's and Child's Health - Azienda Ospedaliera di Padova

Padova, PD, Italy

About this study

Compliance during diagnostic or therapeutic procedures is a very frequent challenge in children. Procedural sedation and analgesia represents an effective answer to this problem. Electroencephalogram (EEG) is a procedure which needs stillness for a medium-long period. Whereas the majority of children carry out this procedure without sedation, patients with behavioral problems, who frequently need to rule out the presence of seizures as associated symptoms or different disease, often show an insufficient compliance. Sedative drugs usually interfere with EEG cerebral waves pattern, so they can not be used. Dexmedetomidine is a selective ∝2-adrenergic agonist with prevalent sedative and anxiolytic properties, with a long effect and which does not alter EEG pattern.

The aim of this interventional study is to evaluate effectiveness, safety and feasibility of dexmedetomidine for sedation during EEG in children who are not cooperative.

Children referred to the Pediatric Neurology Department of the Pediatric Hospital of Padova and required sedation to perform EEG were considered in the study.

The protocol establishes to administer dexmedetomidine IV 2 μg/kg in 10 minutes (loading dose) followed by continuous infusion at a rate of 1 μg/kg/h until procedure was complete. The loading dose can be repeated up to two times, if needed, to achieve the targeted level of Pediatric Sedation State Scale (PSSS) of 2 (quiet, asleep or awake, not moving during procedure, and no frown or brow furrow indicating pain or anxiety, no verbalization of any complaint). Vital signs (SatO2, RR, EtCO2, HR, BP) and level of sedation are recorded before, during and after procedure until the complete awake of the patient. The quality of the EEG pattern was also evaluated. Occurrence and type of adverse events are registered during this period. Finally, the caregivers' opinion about the quality of the sedation and the presence of any sleep disturbance at home during the next 12 hours after the procedure were considered.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • children affected by behavior disorders who underwent EEG procedure with sedation
  • written informed consent

Exclusion criteria

  • ASA > 2
  • hypersensitivity of active substance
  • therapy with beta blockers or digoxin, arrhythmia

Treatment and study plan

Dexmedetomidine

Drug

To administer dexmedetomidine IV 2 μg/kg in 10 minutes (loading dose) followed by continuous infusion at a rate of 1 μg/kg/h until procedure was complete

Other names: dexdor

Primary outcomes

  1. Number of Patients That Reach a Score Equal or Lower Than 2 Ten Minutes After the Infusion of Dexmedetomidine (Assessed With the PSSS Pediatric Sedation State Scale)

    Time frame: 10 minutes

    the PSSS is a validated scale for assessing the level of procedural sedation. It is a 6 items scale , from 0 to 5, where 5 is an alert patient and 0 is a deep sedation with abnormal vital signs. We evaluate patients 10 minutes after the infusion of dexmedetomidine.

Secondary outcomes

  1. Number of Patients With Adverse Events

    Time frame: during and immediately after DEX infusion, up to 150 minutes after DEX infusion (time to first awakening)

    any adverse event potentially related with DEX-administration

Sponsors and collaborators

Lead sponsor

Azienda Ospedaliera di Padova

Other

Registry information

Official study title

The Use of Dexmedetomidine for Procedural Sedation During EEG in Children Affected by Behavioural Disorders

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jan 10, 2019
Registry last updated
Feb 2, 2021

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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