{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,20]],"date-time":"2026-09-20T04:43:58Z","timestamp":1789879438464,"version":"4.0.1"},"reference-count":41,"publisher":"Springer Science and Business Media LLC","issue":"1","funder":[{"name":"Health Technology Assessment Programme (GB)","award":["12\/127\/134"],"award-info":[{"award-number":["12\/127\/134"]}]}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["Trials"],"published-print":{"date-parts":[[2017,12]]},"DOI":"10.1186\/s13063-017-2010-8","type":"journal-article","created":{"date-parts":[[2017,6,19]],"date-time":"2017-06-19T12:31:58Z","timestamp":1497875518000},"update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":27,"title":["Emergency treatment with levetiracetam or phenytoin in status epilepticus in children\u2014the EcLiPSE study: study protocol for a randomised controlled trial"],"prefix":"10.1186","volume":"18","author":[{"name":"supported by Paediatric Emergency Research in the United Kingdom & Ireland (PERUKI)","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mark D.","family":"Lyttle","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Carrol","family":"Gamble","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Shrouk","family":"Messahel","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Helen","family":"Hickey","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Anand","family":"Iyer","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kerry","family":"Woolfall","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Amy","family":"Humphreys","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Naomi E. A.","family":"Bacon","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Louise","family":"Roper","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Franz E.","family":"Babl","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Stuart R.","family":"Dalziel","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mary","family":"Ryan","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Richard E.","family":"Appleton","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2017,6,19]]},"reference":[{"issue":"11","key":"2010_CR1","doi-asserted-by":"crossref","first-page":"948","DOI":"10.1136\/adc.2006.107516","volume":"92","author":"CL Novorol","year":"2007","unstructured":"Novorol CL, Chin RFM, Scott RC. Outcome of convulsive status epilepticus: a review. Arch Dis Child. 2007;92(11):948\u201351.","journal-title":"Arch Dis Child"},{"issue":"9531","key":"2010_CR2","doi-asserted-by":"crossref","first-page":"222","DOI":"10.1016\/S0140-6736(06)69043-0","volume":"368","author":"RF Chin","year":"2006","unstructured":"Chin RF, Neville BG, Peckham C, Bedford H, Wade A, Scott RC. Incidence, cause, and short-term outcome of convulsive status epilepticus in childhood: prospective population-based study. Lancet. 2006;368(9531):222\u20139.","journal-title":"Lancet"},{"key":"2010_CR3","unstructured":"PICANet annual report 2010. http:\/\/www.picanet.org.uk\/Documentation\/ . Accessed 15 Dec 2016"},{"issue":"11","key":"2010_CR4","doi-asserted-by":"crossref","first-page":"1584","DOI":"10.1136\/jnnp.2003.032797","volume":"75","author":"RFM Chin","year":"2004","unstructured":"Chin RFM, Verhulst L, Neville BGR, Peters MJ, Scott RC. Inappropriate emergency management of status epilepticus in children contributes to need for intensive care. J Neurol Neurosurg Psychiatry. 2004;75(11):1584\u20138.","journal-title":"J Neurol Neurosurg Psychiatry"},{"key":"2010_CR5","unstructured":"Advanced paediatric life support: a practical approach to emergencies (APLS) 6th edition. http:\/\/www.alsg.org\/uk\/Publications . Accessed 15 Dec 2016."},{"issue":"2","key":"2010_CR6","doi-asserted-by":"crossref","first-page":"83","DOI":"10.1097\/PEC.0b013e318196ea6e","volume":"25","author":"S Lewena","year":"2009","unstructured":"Lewena S, Pennington V, Acworth J, Thornton S, Ngo P, McIntyre S, et al. Emergency management of pediatric convulsive status epilepticus: a multicenter study of 542 patients. Pediatr Emerg Care. 2009;25(2):83\u20137.","journal-title":"Pediatr Emerg Care"},{"issue":"6","key":"2010_CR7","doi-asserted-by":"crossref","first-page":"369","DOI":"10.1016\/S1059-1311(02)00338-2","volume":"12","author":"RE Appleton","year":"2003","unstructured":"Appleton RE, Gill A. Adverse events associated with intravenous phenytoin in children: a prospective study. Seizure. 2003;12(6):369\u201372.","journal-title":"Seizure"},{"issue":"2","key":"2010_CR8","doi-asserted-by":"crossref","first-page":"161","DOI":"10.1385\/NCC:3:2:161","volume":"3","author":"S Craig","year":"2005","unstructured":"Craig S. Phenytoin poisoning. Neurocrit Care. 2005;3(2):161\u201370.","journal-title":"Neurocrit Care"},{"issue":"2","key":"2010_CR9","doi-asserted-by":"crossref","first-page":"108","DOI":"10.1111\/j.1742-6723.2010.01269.x","volume":"22","author":"K Gallop","year":"2010","unstructured":"Gallop K. Review article: phenytoin use and efficacy in the ED. Emerg Med Australas. 2010;22(2):108\u201318.","journal-title":"Emerg Med Australas"},{"issue":"10","key":"2010_CR10","doi-asserted-by":"crossref","first-page":"1634","DOI":"10.1007\/s00415-009-5166-7","volume":"256","author":"S Berning","year":"2009","unstructured":"Berning S, Boesebeck F, van Baalen A, Kellinghaus C. Intravenous levetiracetam as treatment for status epilepticus. J Neurol. 2009;256(10):1634\u201342.","journal-title":"J Neurol"},{"issue":"2","key":"2010_CR11","doi-asserted-by":"crossref","first-page":"79","DOI":"10.1177\/1756285608100460","volume":"2","author":"E Trinka","year":"2009","unstructured":"Trinka E, Dobesberger J. Review: new treatment options in status epilepticus: a critical review on intravenous levetiracetam. Ther Adv Neurol Disord. 2009;2(2):79\u201391.","journal-title":"Ther Adv Neurol Disord"},{"issue":"5","key":"2010_CR12","doi-asserted-by":"crossref","first-page":"588","DOI":"10.1136\/jnnp.2007.130260","volume":"79","author":"S Knake","year":"2008","unstructured":"Knake S, Gruener J, Hattemer K, Klein KM, Bauer S, Oertel WH, et al. Intravenous levetiracetam in the treatment of benzodiazepine refractory status epilepticus. J Neurol Neurosurg Psychiatry. 2008;79(5):588\u20139.","journal-title":"J Neurol Neurosurg Psychiatry"},{"issue":"2\u20133","key":"2010_CR13","doi-asserted-by":"crossref","first-page":"143","DOI":"10.1016\/j.eplepsyres.2008.05.004","volume":"81","author":"C Michaelides","year":"2008","unstructured":"Michaelides C, Thibert RL, Shapiro MJ, Kinirons P, John T, Manchharam D, et al. Tolerability and dosing experience of intravenous levetiracetam in children and infants. Epilepsy Res. 2008;81(2\u20133):143\u20137.","journal-title":"Epilepsy Res"},{"issue":"3","key":"2010_CR14","doi-asserted-by":"crossref","first-page":"477","DOI":"10.1016\/j.yebeh.2008.01.004","volume":"12","author":"S R\u00fcegg","year":"2008","unstructured":"R\u00fcegg S, Naegelin Y, Hardmeier M, Winkler DT, Marsch S, Fuhr P. Intravenous levetiracetam: treatment experience with the first 50 critically ill patients. Epilepsy Behav. 2008;12(3):477\u201380.","journal-title":"Epilepsy Behav"},{"issue":"8","key":"2010_CR15","doi-asserted-by":"crossref","first-page":"946","DOI":"10.1177\/0883073808331351","volume":"24","author":"JW Wheless","year":"2009","unstructured":"Wheless JW, Clarke D, Hovinga CA, Ellis M, Durmeier M, McGregor A, et al. Rapid infusion of a loading dose of intravenous levetiracetam with minimal dilution: a safety study. J Child Neurol. 2009;24(8):946\u201351.","journal-title":"J Child Neurol"},{"issue":"1","key":"2010_CR16","doi-asserted-by":"crossref","first-page":"37","DOI":"10.1016\/j.pediatrneurol.2009.02.016","volume":"41","author":"BF Kirmani","year":"2009","unstructured":"Kirmani BF, Crisp ED, Kayani S, Rajab H. Role of intravenous levetiracetam in acute seizure management of children. Pediatr Neurol. 2009;41(1):37\u20139.","journal-title":"Pediatr Neurol"},{"issue":"7","key":"2010_CR17","doi-asserted-by":"crossref","first-page":"529","DOI":"10.1016\/j.seizure.2012.05.010","volume":"21","author":"A McTague","year":"2012","unstructured":"McTague A, Kneen R, Kumar R, Spinty S, Appleton R. Intravenous levetiracetam in acute repetitive seizures and status epilepticus in children: experience from a children\u2019s hospital. Seizure. 2012;21(7):529\u201334.","journal-title":"Seizure"},{"issue":"4","key":"2010_CR18","doi-asserted-by":"crossref","first-page":"645","DOI":"10.1007\/s00415-011-6227-2","volume":"259","author":"UK Misra","year":"2011","unstructured":"Misra UK, Kalita J, Maurya PK. Levetiracetam versus lorazepam in status epilepticus: a randomized, open labeled pilot study. J Neurol. 2011;259(4):645\u20138.","journal-title":"J Neurol"},{"key":"2010_CR19","doi-asserted-by":"crossref","unstructured":"Prasad M, Krishnan PR, Sequeira R, Al-Roomi K. Anticonvulsant therapy for status epilepticus. Cochrane Database Syst Rev. 2014;10(9):CD003723.pub3.","DOI":"10.1002\/14651858.CD003723.pub3"},{"issue":"4","key":"2010_CR20","doi-asserted-by":"crossref","first-page":"233","DOI":"10.1016\/j.seizure.2012.01.008","volume":"21","author":"J Zelano","year":"2012","unstructured":"Zelano J, Kumlien E. Levetiracetam as alternative stage two antiepileptic drug in status epilepticus: a systematic review. Seizure. 2012;21(4):233\u20136.","journal-title":"Seizure"},{"key":"2010_CR21","doi-asserted-by":"crossref","first-page":"192","DOI":"10.3389\/fneur.2013.00192","volume":"4","author":"C Wright","year":"2013","unstructured":"Wright C, Downing J, Mungall D, Khan O, Williams A, Fonkem E, et al. Clinical pharmacology and pharmacokinetics of levetiracetam. Front Neurol. 2013;4:192.","journal-title":"Front Neurol"},{"key":"2010_CR22","doi-asserted-by":"crossref","unstructured":"Ramael S, Daoust A, Otoul C, Toublanc N, Troenaru M, Lu Z (Sarah), et al. Levetiracetam intravenous infusion: a randomized, placebo-controlled safety and pharmacokinetic study. Epilepsia. 2006;47(7):1128\u201335.","DOI":"10.1111\/j.1528-1167.2006.00586.x"},{"issue":"2","key":"2010_CR23","doi-asserted-by":"crossref","first-page":"165","DOI":"10.1007\/s12028-009-9304-y","volume":"12","author":"JP Szaflarski","year":"2009","unstructured":"Szaflarski JP, Sangha KS, Lindsell CJ, Shutter LA. Prospective, randomized, single-blinded comparative trial of intravenous levetiracetam versus phenytoin for seizure prophylaxis. Neurocrit Care. 2009;12(2):165\u201372.","journal-title":"Neurocrit Care"},{"issue":"5","key":"2010_CR24","doi-asserted-by":"crossref","first-page":"125","DOI":"10.1111\/j.1535-7511.2008.00266.x","volume":"8","author":"LJ Hirsch","year":"2008","unstructured":"Hirsch LJ. Levitating levetiracetam\u2019s status for status epilepticus. Epilepsy Curr. 2008;8(5):125\u20136.","journal-title":"Epilepsy Curr"},{"issue":"6","key":"2010_CR25","doi-asserted-by":"crossref","first-page":"602","DOI":"10.1136\/archdischild-2013-304998","volume":"99","author":"MD Lyttle","year":"2014","unstructured":"Lyttle MD, O\u2019Sullivan R, Hartshorn S, Bevan C, Cleugh F, Maconochie I, et al. Pediatric Emergency Research in the UK and Ireland (PERUKI): developing a collaborative for multicentre research. Arch Dis Child. 2014;99(6):602\u20133.","journal-title":"Arch Dis Child"},{"issue":"11","key":"2010_CR26","doi-asserted-by":"crossref","first-page":"864","DOI":"10.1136\/emermed-2014-204484","volume":"32","author":"S Hartshorn","year":"2015","unstructured":"Hartshorn S, O\u2019Sullivan R, Maconochie IK, Bevan C, Cleugh F, Lyttle MD. Establishing the research priorities of paediatric emergency medicine clinicians in the UK and Ireland. Emerg Med J. 2015;32(11):864\u20138.","journal-title":"Emerg Med J"},{"key":"2010_CR27","unstructured":"Epilepsies: diagnosis and management, National Institute for Health and Care Excellence. https:\/\/www.nice.org.uk\/guidance\/cg137 . Accessed 15 Dec 2016."},{"issue":"6","key":"2010_CR28","doi-asserted-by":"crossref","first-page":"585","DOI":"10.1136\/archdischild-2013-305093","volume":"99","author":"JD Piper","year":"2014","unstructured":"Piper JD, Hawcutt DB, Verghese GK, Spinty S, Newland P, Appleton R. Phenytoin dosing and serum concentrations in paediatric patients requiring 20\u00a0mg\/kg intravenous loading. Arch Dis Child. 2014;99(6):585\u20136.","journal-title":"Arch Dis Child"},{"issue":"5","key":"2010_CR29","doi-asserted-by":"crossref","first-page":"e005045","DOI":"10.1136\/bmjopen-2014-005045","volume":"4","author":"K Woolfall","year":"2014","unstructured":"Woolfall K, Young B, Frith L, Appleton R, Iyer A, Messahel S, et al. Doing challenging research studies in a patient-centred way: a qualitative study to inform a randomised controlled trial in the paediatric emergency care setting. BMJ Open. 2014;4(5):e005045.","journal-title":"BMJ Open"},{"issue":"7367","key":"2010_CR30","doi-asserted-by":"crossref","first-page":"766","DOI":"10.1136\/bmj.325.7367.766","volume":"325","author":"J Donovan","year":"2002","unstructured":"Donovan J, Little P, Mills N, Smith M, Brindle L, Jacoby A, et al. Improving design and conduct of randomised trials by embedding them in qualitative research: ProtecT (prostate testing for cancer and treatment) study. BMJ. 2002;325(7367):766\u201370.","journal-title":"BMJ"},{"issue":"7","key":"2010_CR31","doi-asserted-by":"crossref","first-page":"e21604","DOI":"10.1371\/journal.pone.0021604","volume":"6","author":"V Shilling","year":"2011","unstructured":"Shilling V, Williamson PR, Hickey H, Sowden E, Beresford MW, Smyth RL, et al. Communication about children\u2019s clinical trials as observed and experienced: qualitative study of parents and practitioners. PLoS One. 2011;6(7):e21604.","journal-title":"PLoS One"},{"issue":"6","key":"2010_CR32","doi-asserted-by":"crossref","first-page":"349","DOI":"10.1093\/intqhc\/mzm042","volume":"19","author":"A Tong","year":"2007","unstructured":"Tong A, Sainsbury P, Craig J. Consolidated criteria for reporting qualitative research (COREQ): 32-item checklist for interviews and focus groups. Int J Qual Health Care. 2007;19(6):349\u201357.","journal-title":"Int J Qual Health Care"},{"issue":"4","key":"2010_CR33","doi-asserted-by":"crossref","first-page":"391","DOI":"10.1023\/A:1020909529486","volume":"36","author":"H Boeije","year":"2002","unstructured":"Boeije H. A purposeful approach to the constant comparative method in the analysis of qualitative interviews. Qual Quant. 2002;36(4):391\u2013409.","journal-title":"Qual Quant"},{"issue":"1","key":"2010_CR34","doi-asserted-by":"crossref","first-page":"97","DOI":"10.1177\/1468794106058877","volume":"6","author":"A Bryman","year":"2006","unstructured":"Bryman A. Integrating quantitative and qualitative research: how is it done? Qual Res. 2006;6(1):97\u2013113.","journal-title":"Qual Res"},{"issue":"4","key":"2010_CR35","doi-asserted-by":"crossref","first-page":"436","DOI":"10.2307\/798843","volume":"12","author":"BG Glaser","year":"1965","unstructured":"Glaser BG. The constant comparative method of qualitative analysis. Soc Probl. 1965;12(4):436\u201345.","journal-title":"Soc Probl"},{"issue":"9481","key":"2010_CR36","doi-asserted-by":"crossref","first-page":"205","DOI":"10.1016\/S0140-6736(05)66909-7","volume":"366","author":"J McIntyre","year":"2005","unstructured":"McIntyre J, Robertson S, Norris E, Appleton R, Whitehouse WP, Phillips B, et al. Safety and efficacy of buccal midazolam versus rectal diazepam for emergency treatment of seizures in children: a randomised controlled trial. Lancet. 2005;366(9481):205\u201310.","journal-title":"Lancet"},{"key":"2010_CR37","unstructured":"Clinical trials\u2014Regulation EU No 536\/2014\u2014European Commission. http:\/\/ec.europa.eu\/health\/human-use\/clinical-trials\/regulation\/index_en.htm . Accessed 15 Dec 2016."},{"key":"2010_CR38","unstructured":"The medicines for human use (clinical trials) and blood safety and quality (amendment) regulations 2008. http:\/\/www.legislation.gov.uk\/uksi\/2008\/941\/contents\/made . Accessed 15 Dec 2016."},{"issue":"1","key":"2010_CR39","doi-asserted-by":"crossref","first-page":"49","DOI":"10.1136\/archdischild-2015-309245","volume":"101","author":"K Woolfall","year":"2016","unstructured":"Woolfall K, Frith L, Dawson A, Gamble C, Lyttle MD, CONNECT advisory group, et al. Fifteen-minute consultation: an evidence-based approach to research without prior consent (deferred consent) in neonatal and paediatric critical care trials. Arch Dis Child Educ Pract Ed. 2016;101(1):49\u201353.","journal-title":"Arch Dis Child Educ Pract Ed"},{"key":"2010_CR40","unstructured":"CONNECT\u2014Institute of Psychology Health and Society\u2014University of Liverpool. https:\/\/www.liverpool.ac.uk\/psychology-health-and-society\/research\/connect\/ . Accessed 15 Dec 2016."},{"key":"2010_CR41","doi-asserted-by":"crossref","unstructured":"Wheless JW, Treiman DM. The role of the newer antiepileptic drugs in the treatment of generalized convulsive status epilepticus. Epilepsia. 2008;49:74\u201378.","DOI":"10.1111\/j.1528-1167.2008.01929.x"}],"container-title":["Trials"],"original-title":[],"language":"en","link":[{"URL":"http:\/\/link.springer.com\/content\/pdf\/10.1186\/s13063-017-2010-8.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2019,9,26]],"date-time":"2019-09-26T08:08:29Z","timestamp":1569485309000},"score":1,"resource":{"primary":{"URL":"http:\/\/trialsjournal.biomedcentral.com\/articles\/10.1186\/s13063-017-2010-8"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2017,6,19]]},"references-count":41,"journal-issue":{"issue":"1","published-print":{"date-parts":[[2017,12]]}},"alternative-id":["2010"],"URL":"https:\/\/doi.org\/10.1186\/s13063-017-2010-8","relation":{},"ISSN":["1745-6215"],"issn-type":[{"value":"1745-6215","type":"electronic"}],"subject":[],"published":{"date-parts":[[2017,6,19]]},"article-number":"283"}}