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

BMC Pediatrics

Study Protocol

Kam Sinn¹  Nicholas Cheng²  Shane George³  Michael Zhang⁴  Jocelyn Neutze⁵  Natalie Phillips⁶  Simon Craig⁷  Susan Donath⁸  Meredith Borland⁹  Simon Harvey^1,10  Andrew Davidson^1,10  Franz E. Babl^1,11  Ed Oakley^1,11  Cynthia Sharpe^1,12  Megan Bonisch^1,12  Stuart R. Dalziel^1,13  Arjun Rao^1,14  Jeremy Furyk^1,15  Christine Brabyn^1,16  Amit Kochar^1,17 

[1] Canberra Hospital, Canberra, Australian Capital Territory, Australia;Children’s Hospital at Westmead, Sydney, New South Wales, Australia;Gold Coast University Hospital, Southport, Queensland, Australia;University of Queensland, Brisbane, Queensland, Australia;Bond University, Gold Coast, Queensland, Australia;John Hunter Hospital, Newcastle, New South Wales, Australia;Kidz First Hospital, Auckland, New Zealand;Lady Cilento Children’s Hospital, Brisbane, Queensland, Australia;Monash Medical Centre, Victoria, Australia;Murdoch Childrens Research Institute, Victoria, Australia;Princess Margaret Hospital, Perth, Western Australia, Australia;Royal Children’s Hospital, Melbourne, Victoria, Australia;Royal Children’s Hospital, Melbourne, Victoria, Australia;Murdoch Childrens Research Institute, Victoria, Australia;Department of Paediatrics, University of Melbourne, Victoria, Australia;Starship Children’s Hospital, Private Bag 92024, 1142, Auckland, New Zealand;Starship Children’s Hospital, Private Bag 92024, 1142, Auckland, New Zealand;Liggins Institute, University of Auckland, Auckland, New Zealand;Sydney Children’s Hospital, Randwick, New South Wales, Australia;The Townsville Hospital, Townsville, Queensland, Australia;James Cook University, Townsville, Queensland, Australia;Waikato Hospital, Hamilton, New Zealand;Women’s and Children’s Hospital, Adelaide, South Australia, Australia;

关键词: Convulsive status epilepticus;    Paediatrics;    Emergency medicine;    Levetiracetam;    Phenytoin;    Intervention study;    Randomised controlled trial;   

DOI  :  10.1186/s12887-017-0887-8

 received in 2016-11-14, accepted in 2017-05-17,  发布年份 2017

来源: Springer

【 摘 要 】

BackgroundConvulsive 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/Design200 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.DiscussionThis 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.Trial registrationProspectively registered with the Australian and New Zealand Clinical Trial Registry (ANZCTR): ACTRN12615000129583 (11/2/2015). UTN U1111–1144-5272. ConSEPT protocol version 4 (12/12/2014).

【 授权许可】

CC BY   
© The Author(s). 2017