Bjornson CL, Klassen TP, Williamson J, Brant R, et al; Pediatric Emergency Research Canada Network. A randomized trial of a single dose of oral dexamethasone for mild croup. N Engl J Med. 2004 Sep 23;351(13):1306-13. PMID: 15385657
What we already know: Croup, also known as acute laryngotracheobronchitis, is a disease that commonly affects the pediatric population. Corticosteroids have been established as effective in moderate to severe croup, but had not been well studied in children who present with mild symptoms, which account for over 60% of patients. Prior to this study, only two publications focused on treatment of mild croup with dexamethasone, and neither were strong.
Why is this study important: Children with mild croup, who account for the majority of patients, are routinely discharged home without treatment. Since most of them have an uncomplicated course, the authors sought to establish evidence of benefit prior to advocating for steroid treatment in an otherwise transient and benign disease.
Brief overview of the study:
- Multicenter, randomized, double-blind, placebo-controlled clinical trial
- 4 Canadian pediatric EDs
- 720 children with mild croup based on the Westley croup score
- Randomized to either a single dose of oral dexamethasone (0.6 mg/kg) or placebo
- Primary outcome: return to a care provider for croup within 7 days of treatment
- 15.3% of the placebo group returned versus only 7.3% of the placebo (statistically significant)
- Secondary outcome: persistent symptoms 1, 2, and 3 days after treatment
- In the first 24 hours, there was greater croup severity in the placebo group compared to the dexamethasone group, with an odds ratio of 3.2.
- By the 3rd day, differences between the groups disappeared, and symptoms resolved in greater than 75% of both groups
- Other outcomes: children treated with dexamethasone lost an average of 2.9 hours of sleep versus 4.2 hours in the placebo group (P<0.001); amount of stress experienced by the parent in the first 24 hours also decreased
Limitations: Outcome measures were gathered by telephone interviews with parents on days 1, 2, 3, 7, and 21 after treatment. To determine the symptom severity score, parents were asked if their children had either a seal-like barking cough or stridor, which relies on self-reported data and may be inaccurate. The study also noted that “additional treatments, provided at the discretion of the attending physician, could include mist, antibiotics, and nebulized epinephrine or beta-agonists. Because none of these treatments alter croup symptoms for more than two hours, at most, they were not expected to interfere with the assessment of the effectiveness of dexamethasone.”
Take home message: Though the majority of pediatric patients who present with croup have mild symptoms that resolve on their own, this study provided evidence to support the use of a single dose of dexamethasone 0.6 mg/kg in their treatment, which reduced the number of children who bounced back, had less hours of sleep lost, and less stress experienced by parents.