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

Abstract

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 α ₂-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. 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 (2 μ g/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. 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. https://www.chictr.org.cn/showproj.html?proj= 320640 , ChiCTR2600126783.