Oral steroids safe, effective for treating croup in children
Low-dose dexamethasone and prednisolone are equally effective in the treatment of croup in children, according to data from the Topdog* trial.
“Although dexamethasone at 0.6 mg/kg is an established evidence-based treatment of childhood croup (reducing hospital admissions, length of stay and need for endotracheal intubation), alternative corticosteroid regimens are in widespread use based on evidence from small studies and observational data,” the investigators said.
“Our results indicate that it is acceptable to use any of the three commonly used oral steroid regimens [ie, standard- and low-dose dexamethasone and prednisolone] to treat croup in children,” they added.
In Topdog, 1,231 children (mean age, 30 months; mean weight, 14.0 kg; 38 percent girls) were randomized to receive standard dexamethasone (0.6 mg/kg; control, n=410), low-dose dexamethasone (0.15 mg/kg; n=410) or prednisolone (1 mg/kg; n=411).
Results for the primary outcomes were similar across the treatment groups. Specifically, the Westley Croup Score (WCS) 1 hour after treatment was 0.48 with low-dose dexamethasone and 0.49 with prednisolone vs 0.43 with standard treatment (p=0.62 and p=0.40, respectively). Unscheduled medical reattendance rates within 7 days post-treatment were 19.5 percent and 21.7 percent vs 17.8 percent (p=0.59 and p=0.19, respectively). [Pediatrics 2019;doi:10.1542/peds.2018-3772]
Likewise, there were no marked differences observed in secondary outcomes including total hospital stay, ED length of stay, use of nebulized epinephrine (adrenaline) and endotracheal intubation. However, significantly more prednisolone-treated patients required additional steroid doses to cover the duration of illness (vs standard treatment: 18.9 percent vs 11.3 percent; p=0.02).
Adverse events were recorded in four patients. A 30-second febrile convulsion occurred about 30 minutes after dexamethasone dosing, although the event was not attributed to the medication. Insomnia developed with prednisolone, with the dose given at ∼5:00 pm and the patient being awake until 3:00 am. Finally, in the low-dose dexamethasone group, one patient was transferred back to the ED from the ED short-stay unit and treated with nebulized epinephrine for possible stridor, and another patient developed hyperactivity 30 minutes after dosing.
These data from Topdog confirm the clinical experience of safety and efficacy of oral steroids for croup, according to the investigators. [Evid Based Child Health 2014;9:733-747; BMJ Clin Evid 2014;2014:321; CMAJ 2013;185:1317-1323; Cochrane Database Syst Rev 2011;1:CD001955]
They pointed out that the two primary outcome measures examined—WCS (assessed at baseline, at 1 hour after treatment, hourly up to 6 hours), an objective measure of acute severity and improvement, and unscheduled medical reattendance rate, a real-world clinically relevant outcome—are complementary, having implications for patient and family satisfaction, as well as use of resources in hospitals and the wider community.
“Dexamethasone is generally not available outside of the hospital environment, so there is a distinct advantage of being able to use prednisolone to treat croup in the community setting. We chose not to use masking agents in the preparation of trial medications because palatability issues affect the real-world utility of these medications, especially in paediatric populations,” they added.
The investigators suggested the apparent weakening performance of low-dose dexamethasone (0.15 mg/kg) at the 3-hour assessment in Topdog be further explored in future studies. “This effect may be due to a small number of patients who do not respond to oral steroid treatment within 1–2 hours, constituting a treatment-resistant cohort… These nonresponders possibly have different responses to steroid treatment or require higher doses to effectively treat their croup.”
*Trial of Prednisolone/Dexamethasone Oral Glucocorticoid