FEBCON-ED

A stepped- wedge cluster randomised controlled clinical trial of usual care vs regular antipyretics for children presenting with a FEBrile CONvulsion to the Emergency Department.

Febrile convulsions are the most common form of childhood seizures and the most common neurological presentation to the Emergency Department (ED). Across Australia, they account for nearly 24,000 ED visits each year.

Unfortunately, one in every five to ten children will experience another seizure within the same illness, and one in three children will have at least one additional febrile convulsion in the future; a source of significant additional burden to both families and health care services. In addition to direct health costs, febrile convulsions cause considerable family distress, both during and after the event.

The purpose of this study is to determine whether the use of paracetamol or ibuprofen makes any difference to the risk of another febrile convulsion (fit) within the same illness in children aged 6 months- 6 years old who have presented to the Emergency Department (ED) with a febrile convulsion. The study will also help determine if paracetamol or ibuprofen given regularly reduces hospital re-attendance with febrile convulsion, health care service use and costs. We are also interested in long-term follow-up of children who have had a febrile convulsion.

Information will be collected for the study via parent/guardian questionnaires, medical chart review and data linkage. Depending on our study findings, we will either confirm current practice, or provide definitive evidence to change practice to update clinical guidelines in Australia & New Zealand to recommend this simple, low-cost intervention to improve management of febrile convulsions.

Study design

Stepped- wedge cluster randomised controlled clinical trial

Chief Investigator

Professor Simon Craig

Time frame

2024 – 2028

Funding

NHMRC Clinical Trials and Cohort Studies Grant

Site locations

  • Monash Children’s Hospital, Melbourne – Central Site (CPI Simon Craig)
  • Blacktown & Mount Druitt Hospitals, Blacktown (PI Gillian Greenwood)
  • Box Hill Hospital, Melbourne (PI Paul Buntine)
  • Caboolture Hospital, Caboolture (PI Rebecca Clark)
  • Children’s Hospital at Westmead, Sydney (PI Nicholas Cheng)
  • Flinders Medical Centre, Adelaide (PI Charmaine Gray)
  • Frankston Hospital, Melbourne (PI Gabriel Blecher)
  • Gold Coast University Hospital, Southport (PI Shane George)
  • John Hunter Hospital, Newcastle (PI Michael Zhang)
  • Kidz First Hospital, Auckland (PI Eunicia Tan)
  • Perth Children’s Hospital, Perth (PI Meredith Borland)
  • Queensland Children’s Hospital, Brisbane (PI Natalie Phillips)
  • Redland Hospital, Brisbane (PI Kristy Kimlin)
  • Royal Hobart Hospital, Hobart (PI Viet Tran)
  • Royal North Shore Hospital, Northern Sydney (PI Richard Lennon)
  • St John of God Midland Hospital, Perth (PI Nicole Ghedina)
  • Starship Children’s Hospital, Auckland (PI Stuart Dalziel)
  • Sunshine Coast University Hospital, Birtinya (PI Ruaraidh McRitchie)
  • Sunshine Hospital, Melbourne (PI Andrew Tagg)
  • The Canberra Hospital, Canberra (PI Jamie Lew)
  • The Prince Charles Hospital, Brisbane (PI Faye Jordan)
  • Toowoomba Base Hospital, Toowoomba (PI Alex King)
  • Townsville University Hospital, Townsville (PI Julian Wong)
  • University Hospital Geelong, Geelong (PI Jeremy Furyk)
  • Womens and Childrens Hospital, Adelaide (PI Amit Kochar)

Sample

9600 children aged 6month – 6 years from Australian / New Zealand mixed and paediatric EDs

Contact

simon.craig@monash.edu (CPI) or naomi.loftus (Research Co-ordinator)