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

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.

Study Overview

• Status: Completed
• Conditions: Sleep Deprivation; Electroencephalography; Melatonin; Hydroxyzine; Chloral Hydrate
• Intervention / Treatment: Other: Sedation and Nursing Management in EEG Recording in Children; Drug: Chloral Hydrate; Drug: Hydroxyzine; Drug: Melatonin

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.

• Study Type: Interventional
• Enrollment (Actual): 180
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Isparta, Turkey, 32000
    • Suleyman Demirel University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 months to 5 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Chloral Hydrate; Chloral hydrate was administered orally to children at a dose of 25-50 mg/kg/dose. 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 EEG room for recording. During the sedation, the child's blood pressure, oxygen saturation and pulse were checked every 5 minutes. EEG electrodes were placed in accordance with the international 10-20 electrode positioning system. An average of 30 minutes of EEG recording was made for each patient. The awakening process of children whose EEG recordings were completed was evaluated with the Steward Recovery Score. Individuals with a score of 6 were accepted as awake, and the child's procedure was completed.	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
Experimental: Hydroxyzine; Hydroxyzine was administered orally to children at a dose of 1-2 mg/kg/dose. 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 EEG room for recording. During the sedation, the child's blood pressure, oxygen saturation and pulse were checked every 5 minutes. EEG electrodes were placed in accordance with the international 10-20 electrode positioning system. An average of 30 minutes of EEG recording was made for each patient. The awakening process of children whose EEG recordings were completed was evaluated with the Steward Recovery Score. Individuals with a score of 6 were accepted as awake, and the child's procedure was completed.	Other: Sedation and Nursing Management in EEG Recording in Children; Evaluation of the effect of sedative agents applied during EEG recording in children; Drug: Hydroxyzine; Hydroxyzine
Experimental: Melatonin; Melatonin was administered orally 3 mg up to 15 kilograms, and 6 mg after 15 kilograms.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 EEG room for recording. During the sedation, the child's blood pressure, oxygen saturation and pulse were checked every 5 minutes. EEG electrodes were placed in accordance with the international 10-20 electrode positioning system. An average of 30 minutes of EEG recording was made for each patient. The awakening process of children whose EEG recordings were completed was evaluated with the Steward Recovery Score. Individuals with a score of 6 were accepted as awake, and the child's procedure was completed.	Other: Sedation and Nursing Management in EEG Recording in Children; Evaluation of the effect of sedative agents applied during EEG recording in children; Drug: Melatonin; Melatonin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: Suleyman Demirel University
• Investigators: Principal Investigator: Şerife Tutar, Suleyman Demirel University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2021
• Primary Completion (Actual): December 31, 2021
• Study Completion (Actual): December 31, 2021

Study Registration Dates

• First Submitted: July 15, 2022
• First Submitted That Met QC Criteria: August 8, 2022
• First Posted (Actual): August 9, 2022

Study Record Updates

• Last Update Posted (Actual): August 9, 2022
• Last Update Submitted That Met QC Criteria: August 8, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Dyssomnias; Sleep Wake Disorders; Neurologic Manifestations; Sleep Deprivation; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Protective Agents; Dermatologic Agents; Hypnotics and Sedatives; Antioxidants; Histamine H1 Antagonists; Histamine Antagonists; Histamine Agents; Antipruritics; Melatonin; Hydroxyzine; Chloral Hydrate
• Other Study ID Numbers: 2021

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: Will be shared after the research is published

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No