The theme of the DFTB18 conference was “Science and Story” and Stuart Dalziel brought an explosion of science to the Melbourne stage today by describing, for the first time in an open forum, the results of one of the most eagerly awaited trials of the year.
The Convulsive Status Epilepticus Paediatric Trial (ConSEPT) is an RCT comparing the efficacy of 20mg/kg of phenytoin with 40mg/kg of levetiracetam in seizing kids, run by the PREDICT research network. Convulsive status epilepticus (CSE) is the most common reason for a paediatric category one presentation to emergency departments in Queensland and the second most common reason for children to be admitted to intensive care in the UK. The current Australian APLS algorithm suggests that children over 12 months of age be given 20mg/kg of phenytoin if their seizure continues after 2 doses of midazolam. This is largely based on historical precedent and levetiracetam (Keppra) is creeping further into widespread use, though to date there is no good RCT data to inform this decision. ConSEPT changes this and provides the most robust trial ever performed comparing Levetiracetam with Phenytoin in seizing children.
So what did it show?
Essentially no difference. Levetiracetam was not superior to Phenytoin in stopping paediatric seizures. No differences were shown in termination of seizure activity, need for intubation, need for ICU admission, length of hospital or ICU stay
Is this the final word?
No. we will bring you analysis and discussion of the ConSEPT trial when it is published in full. Trials are also being conducted in the UK and North America looking at the relative efficacy of phenytoin and levetiracetam, with publication of the UK trial expected around the same time as the ConSEPT paper.
So what should I do?
Basically either phenytoin or levetiracetam are OK as a first, second-line agent in paediatric CSE. If one doesn’t work it makes sense to go ahead and give the other while you complete your preparations for intubation.
The study protocol is available here
hi patrick. No it has not been published yet. we will post about it on DFTB when it is. IM leviteracetam was trialled pre-hospital in France and didn’t show a great advantage but I’ve heard a rumour a major ambulance service in Australia is considering trailing it
Hi Ben, can you advise if this study has been published yet? I’ve yet to see much about it in the wider social media? Thanks.
Anyone using Levetiracetam intramuscularly if the midazolam not working?
Read Casey’s take on it here…https://broomedocs.com/2018/09/consept-trial-phenytoin-vs-levetiracetam-in-status-epilepsy/
Comment from David Herd…….. “Disclaimer: I was involved in original study designing phase and may be biased. I advocated for a non-inferiority design based on the clinical question “is keppra as good as phenytoin”. This would have required a larger study. The team decided to continue with a superiority trial and I elected to step down from the study group.
If ConSEPT was positive we have no problem as superiority equals a change of practice now. The study failed to show superiority (although looking at one slide from the presentation it looks like a nonsignificant trend to superiority – or a type II error).
Ben, this study does not show “Essentially no difference” and I warned the study authors that this would be a common misconception. Fortunately the upcoming UK and North American studies may prove superiority (or a meta analysis of all three will).”