Sedation and Nursing Management in EEG Recording in Children

NCT05492812 | Completed

• 1 other identifier: 2021
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Electroencephalography; Melatonin; Chloral Hydrate; Hydroxyzine; Sleep Deprivation

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (3)

Chloral Hydrate

EXPERIMENTAL

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; Drug: Chloral Hydrate

Hydroxyzine

EXPERIMENTAL

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; Drug: Hydroxyzine

Melatonin

EXPERIMENTAL

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; Drug: Melatonin

Interventions

Sedation and Nursing Management in EEG Recording in Children OTHER

Evaluation of the effect of sedative agents applied during EEG recording in children

Chloral Hydrate; Hydroxyzine; Melatonin

Chloral Hydrate DRUG

Chloral Hydrate

Chloral Hydrate

Hydroxyzine DRUG

Hydroxyzine

Hydroxyzine

Melatonin DRUG

Melatonin

Melatonin

Eligibility Criteria

• Age: 1 Year - 7 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Suleyman Demirel University: lead

Study Sites (1)

Suleyman Demirel University

Isparta, 32000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Sleep Deprivation

Interventions

Chloral Hydrate; Hydroxyzine; Melatonin

Condition Hierarchy (Ancestors)

Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Intervention Hierarchy (Ancestors)

Ethylene Glycols; Glycols; Alcohols; Organic Chemicals; Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Tryptamines; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

• Şerife Tutar

  Suleyman Demirel University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Study Record Dates

• First Submitted: July 15, 2022
• First Posted: August 9, 2022
• Study Start: January 1, 2021
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: August 9, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)