Skip to main content
OpenTrials
Completed

NCT Number: NCT04665453

Dexmedetomidine and Melatonin for Sleep Induction for EEG in Children

The aim of the study is to compare the effect of melatonin, given orally, dexmedetomidine, given intranasally, and dexmedetomidine given sublingually on sleep induction, sleep duration, their possible impact on vital functions and technical implementation of EEG.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Electroencephalography Autism Spectrum Disorder Brain Diseases Central Nervous System Diseases Child Child Development Disorders, Pervasive Developmental Disabilities Dexmedetomidine Epilepsy Melatonin Mental Disorders Nervous System Diseases Neurodevelopmental Disorders Sleep

Age range

1 year–20 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Medical Centre Ljubljana

Ljubljana, 1000, Slovenia

About this study

At University Medical Centre Ljubljana (UMCL; Slovenia), the investigators use electroencephalography (EEG) in wakefulness and sleep for diagnostic and therapeutic purposes in children with (suspected) epilepsy. Since epileptiform activity can only be detected during sleep in some patients and because children with intellectual disabilities have sometimes problems with cooperation, EEG in induced sleep is required.

In this study, the investigators will enroll 150 children who need EEG recorded in their sleep. The investigators will compare safety and efficacy of the two active substances, one of which will be given in two possible routes. Fifty children will receive melatonin in the form of a syrup orally, 50 children will receive dexmedetomidine intranasally in the form of a nasal spray, and 50 children will receive dexmedetomidine sublingually. The investigators will monitor the following parameters: the time in which the child falls asleep, vital functions during sleep (blood pressure, blood oxygen saturation, respiratory rate frequency and heart rate frequency), the impact on the technical implementation of EEG, the depth of sleep and waking time. All parents will give their written consent for their child to participate in the study.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age between 1 and 20 years
  • Referral for EEG in sleep
  • Children/young adults whose parents/caregivers were informed about the aims of the study and have signed the Informed consent form

Exclusion criteria

  • Children that were unable to follow the study protocol were excluded during the study

Treatment and study plan

Electroencephalography

Diagnostic Test

Recording of the brain electrical activity during sleep; background activity and sleep phases will be evaluated

Other names: EEG

Monitoring of vital functions

Diagnostic Test

Measuring of respiratory rate, heart rate, SpO2, every 10 minutes after the medicine is given to the patient for the duration of EEG, and after 120 minutes. Blood pressure is measured at the time of application of the medicine, at the end of EEG and after 120 minutes.

Melatonin 0,1mg/kg oral syrup

Drug

Melatonine in the form of syrup will be given orally to child.

Dexmedetomidine 3 mcg/kg sublingually

Drug

Dexmedetomidine in the form of a solution will be given to child sublingually.

Dexmedetomidine 3 mcg/kg intranasally

Drug

Dexmedetomidine in the form of nasal spray will be given to child intranasally.

Primary outcomes

  1. Comparison of the three medical interventions on sleep initiation

    Time frame: During the intervention

    The time-interval between the drug application and time of sleep initiation will be recorded in minutes. These values will be compared across the three arms of the study

  2. Comparison of the three medical interventions on the depth of sleep and the most prominent sleep stage on EEG

    Time frame: During the intervention

    During EEG in sleep, which will be recorderd using a standard 10-20 placement with additional electrodes for breathing and ECG, the EEG background activity will be evaluated for the deepest sleep stage according to the standard EEG classification (Carskadon MA, Dement WC. Normal Human Sleep: an Overview. In: Kryger M, Roth T, Dement WC. Principles and practice of sleep medicine. St.Louis: Saunders/Elsevier, 2011:16-26.). Also, the sleep stage in which the patient will spend the most time will be noted. These values will be compared across the three arms of the study.

Secondary outcomes

  1. Comparison of the three medical interventions on respiratory rate

    Time frame: During the intervention

    Measurement of respiratory rate every 10 minutes after the medicine is given to the patient for the duration of EEG recording, and after 120 minutes. The values will be compared across the three arms of the study.

  2. Comparison of the three medical interventions on heart rate

    Time frame: During the intervention

    Measurement of heart rate every 10 minutes after the medicine is given to the patient for the duration of EEG recording, and after 120 minutes. The values will be compared across the three arms of the study.

  3. Comparison of the three medical interventions on oxygene saturation

    Time frame: During the intervention

    Measurement of oxygene saturation using pulse oximetry every 10 minutes after the medicine is given to the patient for the duration of EEG recording, and after 120 minutes. The values will be compared across the three arms of the study.

  4. Comparison of the three medical interventions on blood pressure

    Time frame: During the intervention

    Measurement of systolic and diastolic blood pressure will be noted at the time of application of the medicine, at the end of EEG and after 120 minutes. These values will be compared across the three arms of the study.

Sponsors and collaborators

Lead sponsor

University Medical Centre Ljubljana

Other

Registry information

Official study title

Comparison of Efficacy of Dexmedetomidine and Melatonin for Sleep Induction for Electroencephalography in Children

Acronym: MeloDex

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Dec 11, 2020
Registry last updated
Nov 2, 2022

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.