{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,21]],"date-time":"2026-09-21T16:51:54Z","timestamp":1790009514550,"version":"4.0.1"},"reference-count":23,"publisher":"Wiley","issue":"3","license":[{"start":{"date-parts":[[2022,7,25]],"date-time":"2022-07-25T00:00:00Z","timestamp":1658707200000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Epilepsia Open"],"published-print":{"date-parts":[[2022,9]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Objective<\/jats:title><jats:p>To discuss the results of the KETASER01 trial and the reasons for its failure, particularly in view of future studies.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>KETASER01 is a multicenter, randomized, controlled, open\u2010label, sequentially designed, non\u2010profit Italian study that aimed to assess the efficacy of ketamine compared with conventional anesthetics in the treatment of refractory convulsive status epilepticus (RCSE) in children.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>During the 5\u2010year recruitment phase, a total of 76 RCSEs treated with third\u2010line therapy were observed in five of the 10 participating Centers; only 10 individuals (five for each study arm; five females, mean age 6.5\u2009\u00b1\u20096.3\u2009years) were enrolled in the KETASER01 study. Two of the five patients (40%) in the experimental arm were successfully treated with ketamine and two of the five (40%) children in the control arm, where successfully treated with thiopental. In the remaining six (60%) enrolled patients, RCSE was not controlled by the randomized anesthetic(s).<\/jats:p><\/jats:sec><jats:sec><jats:title>Significance<\/jats:title><jats:p>The KETASER01 study was prematurely halted due to low eligibility of patients and no successful recruitment. No conclusions can be drawn regarding the objectives of the study. Here, we discuss the KETASER01 results and critically analyze the reasons for its failure in view of future trials.<\/jats:p><\/jats:sec>","DOI":"10.1002\/epi4.12627","type":"journal-article","created":{"date-parts":[[2022,7,14]],"date-time":"2022-07-14T08:03:57Z","timestamp":1657785837000},"page":"532-540","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":14,"title":["KETASER01 protocol: What went right and what went\u00a0wrong"],"prefix":"10.1002","volume":"7","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-8754-7214","authenticated-orcid":false,"given":"Anna","family":"Rosati","sequence":"first","affiliation":[{"name":"Neuroscience Department Meyer Children\u2019s Hospital\u2010University of Florence  Florence Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Manuela","family":"L\u2019Erario","sequence":"additional","affiliation":[{"name":"Intensive Care Unit Meyer Children\u2019s Hospital\u2010University of Florence  Florence Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Roberto","family":"Bianchi","sequence":"additional","affiliation":[{"name":"Intensive Care Unit Bambino Ges\u00f9 Children\u2019s Hospital, IRCCS  Rome Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sara","family":"Olivotto","sequence":"additional","affiliation":[{"name":"Pediatric Neurology Unit Children\u2019s Hospital Vittore Buzzi, ASST Fatebenefratelli Sacco  Milan Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Domenica Immacolata","family":"Battaglia","sequence":"additional","affiliation":[{"name":"Department of Child Neurology and Psychiatry Catholic University  Rome Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Francesca","family":"Darra","sequence":"additional","affiliation":[{"name":"Child Neuropsychiatry Department of Surgical Sciences, Dentistry, Gynecology and Pediatrics University of Verona  Verona Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Paolo","family":"Biban","sequence":"additional","affiliation":[{"name":"Department of Neonatal and Pediatric Intensive Care University Hospital  Verona Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Annibale","family":"Biggeri","sequence":"additional","affiliation":[{"name":"Department of Cardiac, Thoracic, Vascular Sciences and Public Health University of Padua  Padua Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Dolores","family":"Catelan","sequence":"additional","affiliation":[{"name":"Department of Cardiac, Thoracic, Vascular Sciences and Public Health University of Padua  Padua Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Giacomo","family":"Danieli","sequence":"additional","affiliation":[{"name":"Department of Statistics, Computer Science, Applications G. 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