Clinical trial NCT04665453: Dexmedetomidine and Melatonin for Sleep Induction for EEG in Children
Official title: Comparison of Efficacy of Dexmedetomidine and Melatonin for Sleep Induction for Electroencephalography in Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Electroencephalography
Child
Dexmedetomidine
Melatonin
Sleep
Epilepsy
Keywords: Child
Dexmedetomidine
Melatonin
Electroencephalography
Autism Spectrum Disorder
Developmental Delay Disorder
Epilepsy
Sleep
Sleep induction
Lead sponsor: University Medical Centre Ljubljana
Sponsor class: OTHER
First posted: 2020-12-11
Enrollment: 150
Sex: ALL
Minimum age (years): 1
Maximum age (years): 20
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Comparison of the three medical interventions on sleep initiation
timeFrame: During the intervention
measure: Comparison of the three medical interventions on the depth of sleep and the most prominent sleep stage on EEG
timeFrame: During the intervention
Secondary outcomes:
measure: Comparison of the three medical interventions on respiratory rate
timeFrame: During the intervention
measure: Comparison of the three medical interventions on heart rate
timeFrame: During the intervention
measure: Comparison of the three medical interventions on oxygene saturation
timeFrame: During the intervention
measure: Comparison of the three medical interventions on blood pressure
timeFrame: During the intervention
Other outcomes:
Locations:
city: Ljubljana
country: Slovenia
facility: University Medical Centre Ljubljana
Study officials:
References: