CONSEPT
Convulsive Status Epilepticus Paediatric Trial (CONSEPT)
This study aims to determine whether intravenous (IV) levetiracetam or IV phenytoin is the better second line treatment for the emergency management of convulsive status epilepticus (CSE) in children. We hypothesise that children treated with IV levetiracetam for CSE will do better than children treated with IV phenytoin in terms of time to clinical cessation of seizure activity, need for intubation for ongoing seizure management, need for intensive care unit (ICU) admission, serious adverse events, length of hospital stay, health care costs, and long term outcome. This research will be the first randomised controlled trial of second line anticonvulsant medication for paediatric CSE thus strengthening the evidence-based approach to the management of this life-threatening condition.
Study design
Randomised controlled trial
Stuart Dalziel
Time frame
2013 – 2017
Funding
- The Health Research Council in New Zealand
- A+ Trust, Auckland District Health Board, Auckland, New Zealand
- Emergency Medicine Foundation
- Princess Margaret Hospital Foundation
- Eric Ormond Baker Charitable Fund
- Starship Children’s Hospital, Auckland, New Zealand
- Kidz First Hospital, Auckland, New Zealand
- Royal Children’s Hospital, Melbourne, Australia
- Princess Margaret Hospital, Perth, Australia.
- Monash Childrens Hospital, Victoria, Australia.
- Townsville Hospital, Townsville, Queensland, Australia.
- Royal Children’s Hospital, Brisbane, Australia.
- Mater Children’s Hospital, Brisbane, Australia.
- Gold Coast Hospital, Southport, Queensland, Australia.
- Sydney Children’s Hospital, Randwick, Sydney, Australia.
- Children’s Hospital at Westmead, Sydney, Australia.
- John Hunter Hospital, Newcastle, Australia.
- Women’s and Children’s Hospital, Adelaide, Australia.
Sample
200 children aged 3 months – 16 years, presenting with CSE
Clinical trial registrations
Click here
Contact
Publications to date
Furyk JS, George S, Phillips N, Emeto TI, Watt K, O’Brien S, Riney K, Wilson C, Hearps SJ, Borland ML, Dalziel SR, Babl FE; on behalf of the Paediatric Research in Emergency Departments International Collaborative (PREDICT). Status Epilepticus Australasian Registry for Children: A pilot prospective, observational, cohort study of paediatric status epilepticus. Emerg Med Australas. 2022 Oct;34(5):801-807. doi: 10.1111/1742-6723.13988. Epub 2022 Apr 25. PMID: 35466541. [Link]
Pfeiffer CK, Mackay MT, Long E, Stephens D, Dalziel SR, Babl FE; Paediatric Research in Emergency Departments International Collaborative (PREDICT). Parenteral Long-Acting Antiseizure Medications Are Used More Often to Treat Seizure Clusters Than Convulsive Status Epilepticus in the Pediatric Emergency Department. J Child Neurol. 2022 Jun;37(7):589-598. doi: 10.1177/08830738221077751. Epub 2022 Feb 10. PMID: 35142572. [Link]
Pfeiffer CK, Smith K, Bernard S, Dalziel SR, Hearps S, Geis T, Kabesch M, Babl FE; PREDICT Network. Prehospital benzodiazepine use and need for respiratory support in paediatric seizures. Emerg Med J. 2022 Aug;39(8):608-615. doi: 10.1136/emermed-2021-211735. Epub 2022 Jan 25. PMID: 35078857. [Link]
Pfeiffer CK, Smith K, Bernard S, Dalziel SR, Hearps S, Geis T, Kabesch M, Babl FE; PREDICT Network. Prehospital benzodiazepine use and need for respiratory support in paediatric seizures. Emerg Med J. 2022 Jan 25:emermed-2021-211735. doi: 10.1136/emermed-2021-211735. Epub ahead of print. PMID: 35078857. [Link].
Dalziel SR, Borland ML, Furyk J, Bonisch M, Neutze J, Donath S, Francis KL, Sharpe C, Harvey AS, Davidson A, Craig S, Phillips N, George S, Rao A, Cheng N, Zhang M, Kochar A, Brabyn C, Oakley E, Babl FE; PREDICT research network. Levetiracetam versus phenytoin for second-line treatment of convulsive status epilepticus in children (ConSEPT): an open-label, multicentre, randomised controlled trial. Lancet. 2019 Apr 17. pii: S0140-6736(19)30722-6. doi: 10.1016/S0140-6736(19)30722-6. [Epub ahead of print] [link].
Furyk J, Ray R, Watt K, Dalziel SR, Oakely E, Mackay M, Dabscheck G, Riney K, Babl FE, A PREDICT study. Consensus research priorities for paediatric status epilepticus: A Delphi study of health consumers, researchers and clinicians. Seizure. 2018 Feb 5;56:104-109. doi: 10.1016/j.seizure.2018.01.025. [Epub ahead of print]. [Link]
Lewena S., Pennington V., Acworth J., Thornton S., Ngo P., McIntyre S., Krieser D., Neutze J., and Speldewinde D., ‘Emergency Management of Pediatric Convulsive Status Epilepticus: A Multicenter Study of 542 Patients’, Pediatr Emerg Care, (2009) 25 (2), 83-7. [Link]
Babl FE, Sheriff N, Borland M, Acworth J, Neutze J, Krieser D, Ngo P, Schutz J, Thomson F, Cotterell E, Jamison S, Francis P. Emergency management of paediatric status epilepticus in Australia and New Zealand: practice patterns in the context of clinical practice guidelines. J Paediatr Child Health. 2009 Sep;45(9):541-6. doi:10.1111/j.1440-1754.2009.01536.x. Epub 2009 Jul 20. PMID: 19686314. [Link]