Dexmedetomidine and Melatonin for Sleep Induction for EEG in Children

Epilepsy Clinical Trial

— MeloDex  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04665453
• Other study ID #: 0120-597/2019/16
• Status: Completed
• Phase: N/A
• Start date: September 1, 2020
• Est. completion date: October 1, 2022

Study information

• Verified date: November 2022
• Source: University Medical Centre Ljubljana
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: October 1, 2022
• Est. primary completion date: September 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 20 Years

Eligibility

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

Related Conditions & MeSH terms

• Child
• Dexmedetomidine
• Electroencephalography
• Epilepsy
• Melatonin
• Sleep

Intervention

Diagnostic Test:
• Electroencephalography
Recording of the brain electrical activity during sleep; background activity and sleep phases will be evaluated
• 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.

Drug:
• Melatonin 0,1mg/kg oral syrup
Melatonine in the form of syrup will be given orally to child.
• Dexmedetomidine 3 mcg/kg sublingually
Dexmedetomidine in the form of a solution will be given to child sublingually.
• Dexmedetomidine 3 mcg/kg intranasally
Dexmedetomidine in the form of nasal spray will be given to child intranasally.

Locations

Country	Name	City	State
Slovenia	University Medical Centre Ljubljana	Ljubljana

Sponsors (1)

Lead Sponsor	Collaborator
University Medical Centre Ljubljana

Country where clinical trial is conducted

Slovenia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comparison of the three medical interventions on sleep initiation	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	During the intervention
Primary	Comparison of the three medical interventions on the depth of sleep and the most prominent sleep stage on EEG	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.	During the intervention
Secondary	Comparison of the three medical interventions on respiratory rate	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.	During the intervention
Secondary	Comparison of the three medical interventions on heart rate	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.	During the intervention
Secondary	Comparison of the three medical interventions on oxygene saturation	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.	During the intervention
Secondary	Comparison of the three medical interventions on blood pressure	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.	During the intervention