Dexmedetomidine and Melatonin for Sleep Induction for EEG in Children

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-01

Study Completion Date

2022-10-01

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Electroencephalography Child Dexmedetomidine Melatonin Sleep Epilepsy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Melatonin peroral

0,1mg/kg melatonin will be given in the form of a syrup to the participant before EEG and vital functions monitoring

Group Type EXPERIMENTAL

Electroencephalography

Intervention Type DIAGNOSTIC_TEST

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

Monitoring of vital functions

Intervention Type 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

Intervention Type DRUG

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

Dexmedetomidine intranasally

3 mcg/kg of dexmedetomidine in the form of a nasal spray will be given to the participant before EEG and vital functions monitoring

Group Type EXPERIMENTAL

Electroencephalography

Intervention Type DIAGNOSTIC_TEST

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

Monitoring of vital functions

Intervention Type 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.

Dexmedetomidine 3 mcg/kg intranasally

Intervention Type DRUG

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

Dexmedetomidine sublingually

3 mcg/kg of dexmedetomidine will be given to the participant sublingually before EEG and vital functions monitoring

Group Type EXPERIMENTAL

Electroencephalography

Intervention Type DIAGNOSTIC_TEST

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

Monitoring of vital functions

Intervention Type 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.

Dexmedetomidine 3 mcg/kg sublingually

Intervention Type DRUG

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

Interventions

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Electroencephalography

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

Intervention Type DIAGNOSTIC_TEST

Monitoring of vital functions

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.

Intervention Type DIAGNOSTIC_TEST

Melatonin 0,1mg/kg oral syrup

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

Intervention Type DRUG

Dexmedetomidine 3 mcg/kg sublingually

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

Intervention Type DRUG

Dexmedetomidine 3 mcg/kg intranasally

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

Intervention Type DRUG

Other Intervention Names

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EEG

Eligibility Criteria

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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