NCT04665453

Dexmedetomidine and Melatonin for Sleep Induction for EEG in Children

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 150 (actual)
• Sponsor: University Medical Centre Ljubljana · Academic / Other
• Sex: All
• Age: 1 Year – 20 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2020-09-01
• Primary completion: 2022-09-01
• Completion: 2022-10-01
• First posted: 2020-12-11
• Last updated: 2022-11-02

Locations

1 site across 1 country: Slovenia