{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,16]],"date-time":"2026-09-16T17:10:15Z","timestamp":1789578615589,"version":"build-2803163510"},"reference-count":51,"publisher":"American Medical Association (AMA)","issue":"9","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["JAMA Pediatr"],"published-print":{"date-parts":[[2025,9,1]]},"abstract":"Importance<\/jats:title>Intranasal (IN) midazolam is commonly used for procedural sedation in children, but the optimal dose is unclear. Insufficient dosing may result in inadequate sedation, leading to short- and long-term consequences associated with poorly managed procedural pain and distress, whereas doses that are too high may be associated with more adverse events.<\/jats:p><\/jats:sec>Objective<\/jats:title>To determine the optimal dose of IN midazolam for procedural sedation in children undergoing laceration repair.<\/jats:p><\/jats:sec>Design, Setting, and Participants<\/jats:title>This prospective, double-blind, adaptive selection randomized clinical trial used the Levin-Robbins-Leu sequential selection procedure and was conducted between September 2021 and May 2024 at a tertiary care pediatric emergency department. Participants were children aged 6 months to 7 years with a simple laceration who required IN midazolam to facilitate the repair. The sequential selection procedure eliminated doses when they failed to achieve a prespecified rate of adequate sedation state compared with the best-performing dose. If more than 1 dose survived elimination, secondary outcomes of remaining doses were compared. Data were analyzed from June to August 2024.<\/jats:p><\/jats:sec>Interventions<\/jats:title>Doses of 0.2, 0.3, 0.4 or 0.5 mg\/kg of IN midazolam.<\/jats:p><\/jats:sec>Main Outcomes and Measures<\/jats:title>The primary outcome was adequate sedation state, defined as Pediatric Sedation State Scale (PSSS) score of 2, 3, or 4 (of 5) for at least 95% of the procedure; no PSSS score of 0 or 1; procedure start within 17 minutes of IN midazolam administration; and procedure completion. Secondary outcomes included ideal sedation state (PSSS score of 2 or 3 for 100% of the procedure), time to onset of minimal sedation, adverse events, time to recovery, and clinician and caregiver satisfaction.<\/jats:p><\/jats:sec>Results<\/jats:title>Following the sequential selection procedure, a total of 101 children (38 [37.6%] female; median [IQR] age, 3 [2-4] years) were enrolled. The 0.2 and 0.3 mg\/kg doses were eliminated, with 19 children receiving 0.2 mg\/kg and 24 children receiving 0.3 mg\/kg. The 0.4- and 0.5-mg\/kg doses remained at enrollment completion, with 29 children receiving 0.4 mg\/kg and 29 children receiving 0.5 mg\/kg. There were no differences in secondary outcomes between the 2 remaining doses and no serious adverse events with any dose.<\/jats:p><\/jats:sec>Conclusions and Relevance<\/jats:title>In this randomized clinical trial, the optimal doses of IN midazolam for procedural sedation in children undergoing laceration repair were 0.4 and 0.5 mg\/kg. This finding can inform clinical practice and future studies of IN midazolam for procedural sedation.<\/jats:p><\/jats:sec>Trial Registration<\/jats:title>ClinicalTrials.gov Identifier: NCT04586504<\/jats:ext-link><\/jats:p><\/jats:sec>","DOI":"10.1001\/jamapediatrics.2025.2181","type":"journal-article","created":{"date-parts":[[2025,7,28]],"date-time":"2025-07-28T15:00:17Z","timestamp":1753714817000},"page":"979","source":"Crossref","is-referenced-by-count":8,"title":["Optimal Dose of Intranasal Midazolam for Procedural Sedation in Children"],"prefix":"10.1001","volume":"179","author":[{"given":"Daniel S.","family":"Tsze","sequence":"first","affiliation":[{"name":"Division of Pediatric Emergency Medicine, Department of Emergency Medicine, Columbia University Vagelos College of Physicians and Surgeons, New York, New York"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hilary A.","family":"Woodward","sequence":"additional","affiliation":[{"name":"Department of Child Life, NewYork-Presbyterian Morgan Stanley Children\u2019s Hospital, New York, New York"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Son H.","family":"McLaren","sequence":"additional","affiliation":[{"name":"Division of Pediatric Emergency Medicine, Department of Emergency Medicine, Columbia University Vagelos College of Physicians and Surgeons, New York, New York"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Cheng-Shiun S.","family":"Leu","sequence":"additional","affiliation":[{"name":"Department of Biostatistics, Mailman School of Public Health, Columbia University, New York, New York"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"April M. 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