Dexmedetomidine and Melatonin for Sleep Induction for EEG in Children (MeloDex)

University Medical Centre Ljubljana

Status: Completed

Conditions: Electroencephalography; Epilepsy; Child; Dexmedetomidine; Sleep; Melatonin

Treatments: Drug: Dexmedetomidine 3 mcg/kg intranasally; Diagnostic Test: Electroencephalography; Drug: Melatonin 0,1mg/kg oral syrup; Diagnostic Test: Monitoring of vital functions; Drug: Dexmedetomidine 3 mcg/kg sublingually

Study type: Interventional

Funder types: Other

Identifiers

NCT04665453

0120-597/2019/16

Details and patient eligibility

About

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.

Full 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.

Enrollment: 150 patients

Sex: All

Ages: 1 to 20 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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150 participants in 3 patient groups

Melatonin peroral

Experimental group

Description:

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

Treatment:

Drug: Melatonin 0,1mg/kg oral syrup

Diagnostic Test: Electroencephalography

Diagnostic Test: Monitoring of vital functions

Dexmedetomidine intranasally

Experimental group

Description:

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

Treatment:

Diagnostic Test: Electroencephalography

Diagnostic Test: Monitoring of vital functions

Drug: Dexmedetomidine 3 mcg/kg intranasally

Dexmedetomidine sublingually

Experimental group

Description:

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

Treatment:

Drug: Dexmedetomidine 3 mcg/kg sublingually

Diagnostic Test: Electroencephalography

Diagnostic Test: Monitoring of vital functions