None listed
Conditions
Brief summary
The main purpose of this study is to help determine whether recommending 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 ED with a febrile convulsion. The study will also help determine whether paracetamol or ibuprofen given regularly reduces hospital re-attendance with febrile convulsion, health care use and costs. We are also interested in long-term outcomes of children who have had a febrile convulsion. Information will be collected for the study by parent/guardian surveys on enrolment, days 3,7 and at 12 months, and medical chart review (and optional data linkage) at 12 months post ED attendance. Febrile convulsions are the most common paediatric neurological presentation to the emergency department. Depending on our study findings, we will either confirm current practice, or provide definitive evidence to change practice to update clinical guidelines in AUS & NZ to recommend this simple, low-cost intervention to improve management of febrile convulsions.
Interventions
Discharge advice recommending the participant take an antipyretic regularly: either paracetamol 15 mg/kg every 6 hours (four times per day) or ibuprofen 10 mg/kg every 8 hours (three times per day) for the first 24 hours after the febrile convulsion. Antipyretic of the parent/guardian's choice will be provided at discharge if participant requires it.
The treating Emergency Department (ED) Clinician will provide the interventional discharge advice face-to-face prior to the participant being dis
Discharge advice recommending the participant take an antipyretic regularly: either paracetamol 15 mg/kg every 6 hours (four times per day) or ibuprofen 10 mg/kg every 8 hours (three times per day) for the first 24 hours after the febrile convulsion. Antipyretic of the parent/guardian's choice will be provided at discharge if participant requires it. The treating Emergency Department (ED) Clinician will provide the interventional discharge advice face-to-face prior to the participant being discharged home from the ED. Interventional discharge advice will be provided in multiple languages, in hardcopy or electronic formats depending on participant preference. Provision of both verbal and written discharge advice will take less than 5 minutes for the clinician to deliver. Both Participant and Clinician adherence to the intervention will be assessed via the Parent/Guardian questionnaire on day 3 after discharge from the ED. Questions 1,2 and 3 ask the parent/guardian what advice was given, what they understood it to mean, and whether they followed the discharge advice. Participants will be invited to complete parent/guardian surveys on enrolment, day 3,7 and 12 months post ED discharge for febrile convulsion. These may be completed either via REDCap electronic data collection tools, or via phone with a member of the study team. Each questionnaire at each data collection time point will comprise of 3-6 questions and take between 2-5 minutes to complete on each occasion. The FEBCON-ED study utilises a Stepped-Wedge Randomised Clinical Trial (SW-RCT) design and will be undertaken across 25 hospitals within Australia and New Zealand which are members of the PREDICT network. Hospitals will be randomised to one of four sequences. There will be five periods, each 6 months in length. Sequential crossover of clusters from control to intervention will occur until all clusters are exposed. Participating hospital ED study sites are randomised at a site level, and interventional discharge advice will be provided to every eligible participant who attends the ED and is discharged home, according to the study site's randomisation sequence.
Sponsors
Prof Simon Craig
Study design
Allocation
Randomised controlled trial
Intervention model
Other
Primary purpose
Prevention
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
6 Months to 6 Years
Healthy volunteers
No
Inclusion criteria
A child with an ED diagnosis of a febrile convulsion (defined as a seizure occurring in a child without previous afebrile seizures, without significant prior neurological abnormality and without signs of central nervous system infection or metabolic disturbance) who is planned for discharge home after a period of observation from the ED or ED short stay unit.
Exclusion criteria
(a) a child diagnosed with a febrile convulsion who is planned to be admitted to a hospital ward; (b) a child with an ED length of stay of greater than 18 hours (to allow for shorter periods of and/or overnight observation in a short-stay unit or similar setting); (c) a child presenting to the ED with an afebrile convulsion; (d) a child with a history of epilepsy or a history of afebrile seizures; (e) a child with status epilepticus requiring at least one second-line agent (such as phenytoin or levetiracetam) to terminate their seizures; (f) a child with a known allergy to both paracetamol or ibuprofen, or a medical condition in which both these medications would be contraindicated.
Outcome results
None listed