Sedation and Nursing Management in EEG Recording in Children

Sleep Deprivation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05492812
• Other study ID #: 2021
• Status: Completed
• Phase: N/A
• Start date: January 1, 2021
• Est. completion date: December 31, 2021

Study information

• Verified date: August 2022
• Source: Suleyman Demirel University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 180
• Est. completion date: December 31, 2021
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 1 Year to 7 Years

Eligibility

Inclusion Criteria:

• According to the classification determined by the American Society of Anesthesiologist (ASA) (Dripps, 1963; Daabis, 2011), in the risk group of ASA I (normal healthy individual), ASA II (with mild systemic disease), the procedure preparation given by the EEG nurse is in accordance with the educational steps. The children who came to the shooting were included in the study.

Exclusion Criteria:

• Severe systemic disease (neurological, cardiac, respiratory, metabolic and gastrointestinal system), known hypersensitivity to the sedative agent, vomiting after sedative drug administration, waking up during the shooting, failing to fall asleep, and the procedure preparation training steps given by the EEG nurse Children who were not prepared properly were not included in the study.

Related Conditions & MeSH terms

• Electroencephalography
• Hydroxyzine
• Melatonin
• Sleep Deprivation

Intervention

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
• Hydroxyzine
Hydroxyzine
• Melatonin
Melatonin

Locations

Country	Name	City	State
Turkey	Suleyman Demirel University	Isparta

Sponsors (1)

Lead Sponsor	Collaborator
Suleyman Demirel University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Success in falling asleep	After the sedative drug administration, the child was taken to a quiet and dark sleep room in the polyclinic environment with his parents in order to enable the child to fall asleep. In this process, the child was evaluated by the nurse every 5 minutes with the Ramsay Sedation Score. Children with a Ramsay Sedation Score of 4-6 were taken to the electroencephalogram room for recording.	12 month
Primary	Sleep Time	After the sedative drug administration, the child was taken to a quiet and dark sleep room in the polyclinic environment with his parents in order to enable the child to fall asleep. In this process, the child was evaluated by the nurse every 5 minutes with the Ramsay Sedation Score. Children with a Ramsay Sedation Score of 4-6 were taken to the electroencephalogram room for recording.The time elapsed during this period was recorded as the time to fall asleep.	12 month
Primary	Ramsay Sedation Score on electroencephalogram background	After the sedative drug administration, the child was taken to a quiet and dark sleep room in the polyclinic environment with his parents in order to enable the child to fall asleep. In this process, the child was evaluated with the Ramsay Sedation Score. Children with a Ramsay Sedation Score of 4-6 were taken to the electroencephalogram room for recording. Electroencephalogram electrodes were placed in accordance with the international 10-20 electrode positioning system. An average of 30 minutes of electroencephalogram recording was made for each patient. Post-extraction records were evaluated by a pediatric neurologist and recorded in the data collection form.	12 month