Evidence map›Paper›PMID 31005386›Full record

Trial reportLancet (London, England)2019

Levetiracetam versus phenytoin for second-line treatment of convulsive status epilepticus in children (ConSEPT): an open-label, multicentre, randomised controlled trial.

Stuart R Dalziel, Meredith L Borland, Jeremy Furyk, Megan Bonisch, Jocelyn Neutze, Susan Donath, Kate L Francis, Cynthia Sharpe, A Simon Harvey, Andrew Davidson and 11 more

Abstract readComparative StudyEquivalence TrialMulticenter Study
PubMed Publisher
In one paragraph

Trial report in Lancet (London, England), 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 72 papers, 6 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
72citing papers in PubMed, 6 pooled it
20.4field-weighted citation impact, top 1% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

72 citing papers in PubMed, 6 syntheses or guidelines pooled it, 223 citations in OpenAlex.

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  14. Retrospective Safety Review of Undiluted IV Push Levetiracetam in Pediatric Patients.The journal of pediatric pharmacology and therapeutics : JPPT : the official journal of PPAG · 2026
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12 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

21 authors at 14 institutions in 2 countries.

Stuart R DalzielChildren's Emergency Department, Starship Children's Hospital, Auckland, New Zealand; Departments of Surgery, University of Auckland, Auckland, New Zealand; Paediatrics: Child and Youth Health, University of Auckland, Auckland, New Zealand. Electronic address: sdalziel@adhb.govt.nz.
Meredith L BorlandPerth Children's Hospital, Perth, WA, Australia; Division of Emergency Medicine, School of Medicine, University of Western Australia, Perth, WA, Australia; Division of Paediatrics, School of Medicine, University of Western Australia, Perth, WA, Australia.
Jeremy FurykEmergency Department, The Townsville Hospital, Townsville, QLD, Australia; College of Public Health, Medical and Veterinary Sciences, James Cook University, Townsville, QLD, Australia.
Megan BonischChildren's Emergency Department, Starship Children's Hospital, Auckland, New Zealand.
Jocelyn NeutzeKidz First Hospital, Auckland, New Zealand.
Susan DonathMurdoch Children's Research Institute, Parkville, VIC, Australia; Department of Paediatrics, University of Melbourne, Melbourne, VIC, Australia.
Kate L FrancisMurdoch Children's Research Institute, Parkville, VIC, Australia.
Cynthia SharpeChildren's Emergency Department, Starship Children's Hospital, Auckland, New Zealand.
A Simon HarveyMurdoch Children's Research Institute, Parkville, VIC, Australia; Department of Paediatrics, University of Melbourne, Melbourne, VIC, Australia; Royal Children's Hospital, Melbourne, VIC, Australia.
Andrew DavidsonMurdoch Children's Research Institute, Parkville, VIC, Australia; Royal Children's Hospital, Melbourne, VIC, Australia.
Simon CraigMonash Medical Centre, Melbourne, VIC, Australia; Department of Medicine, School of Clinical Sciences, Monash University, Melbourne, VIC, Australia.
Natalie PhillipsQueensland Children's Hospital, Brisbane, QLD, Australia; Child Health Research Centre, University of Queensland, Brisbane, QLD, Australia.
Shane GeorgeChild Health Research Centre, University of Queensland, Brisbane, QLD, Australia; Department of Emergency Medicine, Gold Coast University Hospital, Southport, QLD, Australia; School of Medicine, Griffith University, Gold Coast, QLD, Australia.
Arjun RaoSydney Children's Hospital, Randwick, NSW, Australia; School of Women's and Children's Health, University of New South Wales, Sydney, NSW, Australia.
Nicholas ChengChildren's Hospital at Westmead, Sydney, NSW, Australia.
Michael ZhangEmergency Department, John Hunter Hospital, Newcastle, NSW, Australia.
Amit KocharEmergency Department, Women's and Children's Hospital, Adelaide, SA, Australia.
Christine BrabynEmergency Department, Waikato Hospital, Hamilton, New Zealand.
Ed OakleyMurdoch Children's Research Institute, Parkville, VIC, Australia; Department of Paediatrics, University of Melbourne, Melbourne, VIC, Australia; Royal Children's Hospital, Melbourne, VIC, Australia.
Franz E BablMurdoch Children's Research Institute, Parkville, VIC, Australia; Department of Paediatrics, University of Melbourne, Melbourne, VIC, Australia; Royal Children's Hospital, Melbourne, VIC, Australia.
PREDICT research network
Murdoch Children's Research Institute · AUStarship Children's Health · NZThe University of Melbourne · AUChildren's Hospital at Westmead · AUGriffith University · AUJohn Hunter Hospital · AUMonash Medical Centre · AUPerth Children's HospitalQueensland Children’s Hospital · AUTownsville Hospital · AUUniversity of Auckland · NZUNSW Sydney · AUWaikato Hospital · NZWomen's and Children's Hospital · AU

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundPhenytoin is the current standard of care for second-line treatment of paediatric convulsive status epilepticus after failure of first-line benzodiazepines, but is only effective in 60% of cases and is associated with considerable adverse effects. A newer anticonvulsant, levetiracetam, can be given more quickly, is potentially more efficacious, and has a more tolerable adverse effect profile. We aimed to determine whether phenytoin or levetiracetam is the superior second-line treatment for paediatric convulsive status epilepticus.

methodsConSEPT was an open-label, multicentre, randomised controlled trial conducted in 13 emergency departments in Australia and New Zealand. Children aged between 3 months and 16 years, with convulsive status epilepticus that failed first-line benzodiazepine treatment, were randomly assigned (1:1) using a computer-generated permuted block (block sizes 2 and 4) randomisation sequence, stratified by site and age (≤5 years, >5 years), to receive 20 mg/kg phenytoin (intravenous or intraosseous infusion over 20 min) or 40 mg/kg levetiracetam (intravenous or intraosseous infusion over 5 min). The primary outcome was clinical cessation of seizure activity 5 min after the completion of infusion of the study drug. Analysis was by intention to treat. This trial is registered with the Australian and New Zealand Clinical Trials Registry, number ACTRN12615000129583.

findingsBetween March 19, 2015, and Nov 29, 2017, 639 children presented to participating emergency departments with convulsive status epilepticus; 127 were missed, and 278 did not meet eligibility criteria. The parents of one child declined to give consent, leaving 233 children (114 assigned to phenytoin and 119 assigned to levetiracetam) in the intention-to-treat population. Clinical cessation of seizure activity 5 min after completion of infusion of study drug occurred in 68 (60%) patients in the phenytoin group and 60 (50%) patients in the levetiracetam group (risk difference -9·2% [95% CI -21·9 to 3·5]; p=0·16). One participant in the phenytoin group died at 27 days because of haemorrhagic encephalitis; this death was not thought to be due to the study drug. There were no other serious adverse events.

interpretationLevetiracetam is not superior to phenytoin for second-line management of paediatric convulsive status epilepticus.

fundingHealth Research Council of New Zealand, A+ Trust, Emergency Medicine Foundation, Townsville Hospital Private Practice Fund, Eric Ormond Baker Charitable Fund, and Princess Margaret Hospital Foundation.

Indexed as

AdolescentAgedAnticonvulsantsAustraliaChildChild, PreschoolDrug Administration ScheduleDrug Resistant EpilepsyEmergency Service, HospitalFemaleHumansInfantLevetiracetamMaleNew ZealandPhenytoinAnticonvulsantsLevetiracetamPhenytoin

Identifiers

PMID31005386
OpenAlexW2938191513

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.