MedElevator
Войти в исследования Frontiers in pediatrics · 2026
Clinical efficacy and safety evaluation of dexmedetomidine hydrochloride nasal spray for sedation before examinations in children aged 2 to 6 years: protocol for a randomized controlled trial.
СтатьяНазвание и аннотация: Перевод пока не подготовлен
Обработка статьи · этапы, ошибки и управление
Загрузка состояния…
Ошибки и ограничения
История · было → стало
Состояние обновляется каждые 5 секунд, пока блок открыт. Процент показывается только там, где известен объём работы. Пауза останавливает продолжение этапа; текущий запрос к источнику может завершиться.
Wang Xiaoling, Li Xiong, Lei Xiaoping, Dong Wenbin
Аннотация
BACKGROUND: Children aged 2 to 6 years are prone to fear and resistance during medical examinations, necessitating sedation assistance. Traditional sedation modalities have limitations such as inconvenient operation, slow onset, or respiratory depression. Dexmedetomidine hydrochloride, a highly selective α₂-adrenergic receptor agonist, exerts sedative, analgesic, and anxiolytic effects with minimal respiratory and circulatory impacts. Its nasal spray is rapidly absorbed via the mucosa, avoiding the first-pass effect, and is thus suitable for young children. This study compares intranasal dexmedetomidine hydrochloride with oral chloral hydrate to evaluate the former's clinical efficacy and safety for pre-examination sedation in young children.
METHODS: This is a single-center, prospective, randomized controlled trial conducted at the Children's Medical Center of the Affiliated Hospital of Southwest Medical University. A total of 248 children aged 2-6 years with ASA physical status I/II requiring sedation for outpatient examinations will be enrolled and randomized 1:1 to receive dexmedetomidine hydrochloride nasal spray (2μg/kg, experimental group) or oral chloral hydrate syrup (50 mg/kg, control group) via computer-generated random sequences. Vital signs will be monitored continuously; sedation onset/duration, MOAA/S (sedation depth), and Steward (recovery status) scores will be recorded. Adverse events will be observed to compare sedation success rates and safety between groups.
ETHICS AND DISSEMINATION: This study has been approved by the Medical Ethics Committee of the Affiliated Hospital of Southwest Medical University (Approval No. KY2025368). Results will be disseminated via peer-reviewed publications and conference presentations.
CLINICAL TRIAL REGISTRATION: https://www.chictr.org.cn/showproj.html?proj= 320640, ChiCTR2600126783.
METHODS: This is a single-center, prospective, randomized controlled trial conducted at the Children's Medical Center of the Affiliated Hospital of Southwest Medical University. A total of 248 children aged 2-6 years with ASA physical status I/II requiring sedation for outpatient examinations will be enrolled and randomized 1:1 to receive dexmedetomidine hydrochloride nasal spray (2μg/kg, experimental group) or oral chloral hydrate syrup (50 mg/kg, control group) via computer-generated random sequences. Vital signs will be monitored continuously; sedation onset/duration, MOAA/S (sedation depth), and Steward (recovery status) scores will be recorded. Adverse events will be observed to compare sedation success rates and safety between groups.
ETHICS AND DISSEMINATION: This study has been approved by the Medical Ethics Committee of the Affiliated Hospital of Southwest Medical University (Approval No. KY2025368). Results will be disseminated via peer-reviewed publications and conference presentations.
CLINICAL TRIAL REGISTRATION: https://www.chictr.org.cn/showproj.html?proj= 320640, ChiCTR2600126783.