{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,7]],"date-time":"2026-07-07T05:19:24Z","timestamp":1783401564148,"version":"3.54.6"},"reference-count":33,"publisher":"Wiley","issue":"6","license":[{"start":{"date-parts":[[2015,8,18]],"date-time":"2015-08-18T00:00:00Z","timestamp":1439856000000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"funder":[{"DOI":"10.13039\/501100005918","name":"Christian Medical College, Vellore","doi-asserted-by":"publisher","id":[{"id":"10.13039\/501100005918","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["aao-hnsfjournals.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Otolaryngol.--head neck surg."],"published-print":{"date-parts":[[2015,12]]},"abstract":"<jats:sec><jats:title>Objectives<\/jats:title><jats:p>To evaluate the efficacy and safety of intranasal midazolam and chloral hydrate syrup for procedural sedation in children.<\/jats:p><\/jats:sec><jats:sec><jats:title>Study Design<\/jats:title><jats:p>Prospective randomized placebo\u2010controlled trial (double blind, double dummy).<\/jats:p><\/jats:sec><jats:sec><jats:title>Setting<\/jats:title><jats:p>Tertiary care hospital over 18\u00a0months.<\/jats:p><\/jats:sec><jats:sec><jats:title>Subjects and Methods<\/jats:title><jats:p>Eighty\u2010two children, 1 to 6 years old, undergoing auditory brainstem response testing were randomized to receive either intranasal midazolam with oral placebo or chloral hydrate syrup with placebo nasal spray. Intranasal midazolam was delivered at 0.5\u00a0mg\/kg (100\u00a0mcg per spray) and oral syrup at 50\u00a0mg\/kg. Children not sedated at 30\u00a0minutes had a second dose at half the initial dose. The primary outcomes measured were safety and efficacy. Secondary outcomes were time to onset of sedation, parental separation, nature of parental separation, parental satisfaction, audiologist\u2019s satisfaction, time to recovery, and number of attempts.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>Forty\u2010one children were in each group, and no major adverse events were noted. The chloral hydrate group showed earlier onset of sedation (66%) compared with the intranasal midazolam group (33%). Significant difference in time to recovery was noted in the chloral hydrate group (78\u00a0minutes) versus the intranasal midazolam group (108\u00a0minutes). The parents\u2019 and audiologist\u2019s satisfaction was higher for chloral hydrate (95% and 75%) than for intranasal midazolam (49% and 29%, respectively). Overall, sedation was 95% with chloral hydrate versus 51% with intranasal midazolam. Both drugs maintained sedation.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>Intranasal midazolam and chloral hydrate are both safe and efficacious for pediatric procedural sedation. Chloral hydrate was superior to intranasal midazolam, with an earlier time to onset of sedation, a faster recovery, better satisfaction among parents and the audiologist, and successful sedation.<\/jats:p><\/jats:sec>","DOI":"10.1177\/0194599815599381","type":"journal-article","created":{"date-parts":[[2015,8,18]],"date-time":"2015-08-18T23:29:01Z","timestamp":1439940541000},"page":"1042-1050","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":17,"title":["A Randomized Controlled Trial Comparing Intranasal Midazolam and Chloral Hydrate for Procedural Sedation in Children"],"prefix":"10.1002","volume":"153","author":[{"given":"Marie Christy Sharafine","family":"Stephen","sequence":"first","affiliation":[{"name":"Department of Otolaryngology, Speech, and Hearing Christian Medical College Vellore India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"John","family":"Mathew","sequence":"additional","affiliation":[{"name":"Department of Otolaryngology, Speech, and Hearing Christian Medical College Vellore India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ajoy Mathew","family":"Varghese","sequence":"additional","affiliation":[{"name":"Department of Otolaryngology, Speech, and Hearing Christian Medical College Vellore India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mary","family":"Kurien","sequence":"additional","affiliation":[{"name":"Department of Otolaryngology, Speech, and Hearing Christian Medical College Vellore India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"George Ani","family":"Mathew","sequence":"additional","affiliation":[{"name":"Department of Otolaryngology, Speech, and Hearing Christian Medical College Vellore India"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2015,8,18]]},"reference":[{"key":"e_1_2_9_2_1","doi-asserted-by":"publisher","DOI":"10.3109\/14992027.2011.601469"},{"key":"e_1_2_9_3_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0165-5876(96)01432-2"},{"key":"e_1_2_9_4_1","doi-asserted-by":"publisher","DOI":"10.1542\/peds.2006-2780"},{"key":"e_1_2_9_5_1","doi-asserted-by":"publisher","DOI":"10.1097\/00000542-200204000-00031"},{"key":"e_1_2_9_6_1","unstructured":"National Clinical Guideline Centre.Sedation in children and young people: NICE clinical guidelines No. 112.http:\/\/www.ncbi.nlm.nih.gov\/books\/NBK82237. 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