NCT05492812

Sedation and Nursing Management in EEG Recording in Children

Evaluation of the Effect of Chloral Hydrate, Hydroxyzine and Melatonin Used as Sedative Drugs in EEG Recording in Children

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 180 (actual)
• Sponsor: Suleyman Demirel University · Academic / Other
• Sex: All
• Age: 1 Year – 7 Years
• Healthy volunteers: Accepted

Summary

Electroencephalogram (EEG) has an important place in establishing the correct diagnosis, providing appropriate intervention, and predicting the prognosis in the long term in children. When the literature is examined, it is seen that different sedative drugs (benzodiazepines, barbiturates, phenothiazine, chloral hydrate, hydroxyzine, melatonin, etc.) and their combinations are used to provide sedation during EEG recordings, but there is no ideal sedative drug. Nurses working in the field of pediatric neurology in EEG recordings; It has important roles in preparing the child and parent for the procedure, applying sedation before the procedure, performing the EEG recording properly, monitoring vital signs during the procedure, monitoring the effects of the sedative substance after the procedure, and sending the patient home safely. Pediatric nurses fulfill these roles by adopting a multidisciplinary team approach. In this context, the aim of our research is; The aim of this study is to evaluate the effects of chloral hydrate, hydroxyzine and melatonin, which are used as sedative agents before EEG recording in children, on sleep success, time to fall asleep, side effects and EEG background.

Detailed description

The aim of this study is to evaluate the effects of chloral hydrate, hydroxyzine and melatonin, which are used as sedative agents before EEG recording in children, on sleep success, time to fall asleep, side effects and EEG background.It is a randomized controlled experimental study.The universe of the study consisted of all children who had EEG recordings in the Pediatric Neurology Outpatient Clinic of a tertiary hospital. Its sample is; It comprised 180 children aged 1-7 years who met the inclusion criteria, evaluated for epilepsy, suspected epilepsy, febrile convulsions, and other neurological diseases.G power program was used to determine the sample size of the study. For each group (chloral hydrate, hydroxyzine, melatonin and natural sleep) 45 individuals were included in the study by taking 95% power and 0.05 margin of error while making the calculation. Randomization was carried out in the study in order to provide an equal number of samples for each group (chloral hydrate, hydroxyzine, melatonin and natural sleep) and to avoid bias. "Block randomization method" was used in order to provide equal samples for all four groups in randomization.Data Collection tools of the research; Child's Information Form, Ramsay Sedation Score, Steward Recovery Score. Statistical analyzes of the study were performed with the SPSS 20.0 (IBM Incorp, Chicago, IL, USA) program. Descriptive measures were frequency (percentage ratio) for categorical variables, mean±SD and median for numerical variables; It was presented as Q1-Q3. Conformity of continuous numerical measurements to normal distribution was tested by Kolmogorov-Smirnov method, but it was found that it did not fit normal distribution (p \<0.05). Multivariate logistic regression model was established to determine the properties that are effective on sedative substances. A p value of \<0.05 was considered statistically significant in the entire study. In order to conduct the study, ethical approval from the Antalya Training and Research Hospital Clinical Research Ethics Committee, approval from the Turkish Medicines and Medical Devices Agency, institutional permission from the hospital where the study will be conducted, and written consent from the participants were obtained.

Conditions

• Electroencephalography
• Melatonin
• Chloral Hydrate
• Hydroxyzine
• Sleep Deprivation

Interventions

Type	Name	Description
OTHER	Sedation and Nursing Management in EEG Recording in Children	Evaluation of the effect of sedative agents applied during EEG recording in children
DRUG	Chloral Hydrate	Chloral Hydrate
DRUG	Hydroxyzine	Hydroxyzine
DRUG	Melatonin	Melatonin

Timeline

• Start date: 2021-01-01
• Primary completion: 2021-12-31
• Completion: 2021-12-31
• First posted: 2022-08-09
• Last updated: 2022-08-09

Locations

1 site across 1 country: Turkey (Türkiye)