Dexmedetomidine and Melatonin for Sleep Induction for EEG in Children

NACompletedINTERVENTIONAL
Enrollment

150

Participants

Timeline

Start Date

September 1, 2020

Primary Completion Date

September 1, 2022

Study Completion Date

October 1, 2022

Conditions
ElectroencephalographyChildDexmedetomidineMelatoninSleepEpilepsy
Interventions
DIAGNOSTIC_TEST

Electroencephalography

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

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.

DRUG

Melatonin 0,1mg/kg oral syrup

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

DRUG

Dexmedetomidine 3 mcg/kg sublingually

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

DRUG

Dexmedetomidine 3 mcg/kg intranasally

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

Trial Locations (1)

1000

University Medical Centre Ljubljana, Ljubljana

All Listed Sponsors
lead

University Medical Centre Ljubljana

OTHER

NCT04665453 - Dexmedetomidine and Melatonin for Sleep Induction for EEG in Children | Biotech Hunter | Biotech Hunter