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Dexmedetomidine and Melatonin for Sleep Induction for EEG in Children

NCT04665453 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2022-11-02

No results posted yet for this study

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.

Conditions

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

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.

Sponsors & Collaborators

  • University Medical Centre Ljubljana

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
1 Year
Max Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-09-01
Primary Completion
2022-09-01
Completion
2022-10-01

Countries

  • Slovenia

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04665453 on ClinicalTrials.gov