{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,22]],"date-time":"2026-09-22T22:14:01Z","timestamp":1790115241027,"version":"4.0.1"},"reference-count":31,"publisher":"Wiley","issue":"2","license":[{"start":{"date-parts":[[2023,10,30]],"date-time":"2023-10-30T00:00:00Z","timestamp":1698624000000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"funder":[{"DOI":"10.13039\/100007403","name":"Dagmar Marshalls Fond","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100007403","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/501100008267","name":"Kong Christian den Tiendes Fond","doi-asserted-by":"publisher","id":[{"id":"10.13039\/501100008267","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/501100005111","name":"Rigshospitalet","doi-asserted-by":"publisher","id":[{"id":"10.13039\/501100005111","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Acta Anaesthesiol Scand"],"published-print":{"date-parts":[[2024,2]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Background<\/jats:title><jats:p>Emergence agitation and delirium in children remain a common clinical challenge in the post\u2010anesthetic care unit. Preoperative oral melatonin has been suggested as an effective preventive drug with a favorable safety profile. The oral bioavailability of melatonin, however, is low. Therefore, the MELA\u2010PAED trial aims to investigate the efficacy and safety of intraoperative intravenous melatonin for the prevention of emergence agitation in pediatric surgical patients.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>MELA\u2010PAED is a randomized, double\u2010blind, parallel two\u2010arm, multi\u2010center, superiority trial comparing intravenous melatonin with placebo. Four hundred participants aged 1\u20136\u2009years will be randomized 1:1 to either the intervention or placebo. The intervention consists of intravenous melatonin 0.15\u2009mg\/kg administered approximately 30\u2009min before the end of surgery. Participants will be monitored in the post\u2010anesthetic care unit (PACU), and the Post Hospitalization Behavior Questionnaire for Ambulatory Surgery (PHBQ\u2010AS) will be performed on days 1, 7, and 14 after the intervention. Serious Adverse Events (SAE) will be assessed up to 30\u2009days after the intervention.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>The primary outcome is the incidence of emergence agitation, assessed dichotomously as any Watcha score\u2009&gt;2 during the participant's stay in the post\u2010anesthetic care unit. Secondary outcomes are opioid consumption in the post\u2010anesthetic care unit and adverse events. Exploratory outcomes include SAEs, postoperative pain, postoperative nausea and vomiting, and time to awakening, to first oral intake, and to discharge readiness.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusion<\/jats:title><jats:p>The MELA\u2010PAED trial investigates the efficacy of intravenous intraoperative melatonin for the prevention of emergence agitation in pediatric surgical patients. Results may provide further knowledge concerning the use of melatonin in pediatric perioperative care.<\/jats:p><\/jats:sec>","DOI":"10.1111\/aas.14342","type":"journal-article","created":{"date-parts":[[2023,10,31]],"date-time":"2023-10-31T05:58:58Z","timestamp":1698731938000},"page":"280-286","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":4,"title":["<scp>Intravenous MELAtonin<\/scp> for prevention of Postoperative Agitation and Emergence Delirium in children (<scp>MELA\u2010PAED<\/scp>): A protocol and statistical analysis plan for a randomized clinical trial"],"prefix":"10.1111","volume":"68","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-1149-9946","authenticated-orcid":false,"given":"Anne Louise de Barros","family":"Garioud","sequence":"first","affiliation":[{"name":"Department of Anesthesiology, Juliane Marie Center Copenhagen University Hospital\u2014Rigshospitalet  Copenhagen Denmark"},{"name":"Department of 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