Please use this identifier to cite or link to this item: https://hdl.handle.net/2440/111787
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Type: Journal article
Title: A multicentre randomised controlled trial of levetiracetam versus phenytoin for convulsive status epilepticus in children (protocol): Convulsive Status Epilepticus Paediatric Trial (ConSEPT) - a PREDICT study
Author: Dalziel, S.
Furyk, J.
Bonisch, M.
Oakley, E.
Borland, M.
Neutze, J.
Donath, S.
Sharpe, C.
Harvey, S.
Davidson, A.
Craig, S.
Phillips, N.
George, S.
Rao, A.
Cheng, N.
Zhang, M.
Sinn, K.
Kochar, A.
Brabyn, C.
Babl, F.
Citation: BMC Pediatrics, 2017; 17(1):159-1-159-9
Publisher: BioMed Central
Issue Date: 2017
ISSN: 1471-2431
1471-2431
Statement of
Responsibility: 
Stuart R. Dalziel, Jeremy Furyk, Megan Bonisch, Ed Oakley, Meredith Borland … Kochar Amit … et al.
Abstract: Background: Convulsive status epilepticus (CSE) is the most common life-threatening childhood neurological emergency. Despite this, there is a lack of high quality evidence supporting medication use after first line benzodiazepines, with current treatment protocols based solely on non-experimental evidence and expert opinion. The current standard of care, phenytoin, is only 60% effective, and associated with considerable adverse effects. A newer anti-convulsant, levetiracetam, can be given faster, is potentially more efficacious, with a more tolerable side effect profile. The primary aim of the study presented in this protocol is to determine whether intravenous (IV) levetiracetam or IV phenytoin is the better second line treatment for the emergency management of CSE in children. Methods/Design: 200 children aged between 3 months and 16 years presenting to 13 emergency departments in Australia and New Zealand with CSE, that has failed to stop with first line benzodiazepines, will be enrolled into this multicentre open randomised controlled trial. Participants will be randomised to 40 mg/kg IV levetiracetam infusion over 5 min or 20 mg/kg IV phenytoin infusion over 20 min. The primary outcome for the study is clinical cessation of seizure activity five minutes following the completion of the infusion of the study medication. Blinded confirmation of the primary outcome will occur with the primary outcome assessment being video recorded and assessed by a primary outcome assessment team blinded to treatment allocation. Secondary outcomes include: Clinical cessation of seizure activity at two hours; Time to clinical seizure cessation; Need for rapid sequence induction; Intensive care unit (ICU) admission; Serious adverse events; Length of Hospital/ICU stay; Health care costs; Seizure status/death at one-month post discharge. Discussion: This paper presents the background, rationale, and design for a randomised controlled trial comparing levetiracetam to phenytoin in children presenting with CSE in whom benzodiazepines have failed. This study will provide the first high quality evidence for management of paediatric CSE post first-line benzodiazepines.
Keywords: Convulsive status epilepticus; paediatrics; emergency medicine; levetiracetam; phenytoin; intervention study; randomised controlled trial
Rights: © The Author(s). 2017. This article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.
DOI: 10.1186/s12887-017-0887-8
Grant ID: http://purl.org/au-research/grants/nhmrc/1058560
Appears in Collections:Aurora harvest 3
Paediatrics publications

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