{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,24]],"date-time":"2026-09-24T06:04:21Z","timestamp":1790229861873,"version":"4.1.0"},"reference-count":33,"publisher":"Frontiers Media SA","license":[{"start":{"date-parts":[[2026,9,24]],"date-time":"2026-09-24T00:00:00Z","timestamp":1790208000000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":["frontiersin.org"],"crossmark-restriction":true},"short-container-title":["Front. Pediatr."],"abstract":"\n Background<\/jats:title>\n \n 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\n \u03b1<\/jats:italic>\n \u2082-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.\n <\/jats:p>\n <\/jats:sec>\n \n Methods<\/jats:title>\n \n 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\u20136 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\n \u03bc<\/jats:italic>\n g\/kg, experimental group) or oral chloral hydrate syrup (50\u2005mg\/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.\n <\/jats:p>\n <\/jats:sec>\n \n Ethics and dissemination<\/jats:title>\n 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.<\/jats:p>\n <\/jats:sec>\n \n Clinical Trial Registration<\/jats:title>\n \n https:\/\/www.chictr.org.cn\/showproj.html?proj= 320640<\/jats:ext-link>\n , ChiCTR2600126783.\n <\/jats:p>\n <\/jats:sec>","DOI":"10.3389\/fped.2026.1942624","type":"journal-article","created":{"date-parts":[[2026,9,24]],"date-time":"2026-09-24T05:43:44Z","timestamp":1790228624000},"update-policy":"https:\/\/doi.org\/10.3389\/crossmark-policy","source":"Crossref","is-referenced-by-count":0,"title":["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"],"prefix":"10.3389","volume":"14","author":[{"given":"Xiaoling","family":"Wang","sequence":"first","affiliation":[{"name":"Jinan University","place":["Guangzhou, China"]},{"name":"Department of Neonatology, Children\u2019s Medical 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