Is oral dexamethasone as effective as intramuscular dexamethasone for outpatient management of moderate croup?

Journal of Family Practice, March, 2001 by Warren Newton

Rittichier KK, Ledwith CA. Outpatient treatment of moderate croup with dexamethasone: intramuscular verses oral dosing. Pediatrics 2000; 106:1344-48.

* BACKGROUND Recent meta-analyses have concluded that steroids ameliorate croup, but questions remain about the effectiveness of oral dosing.

* POPULATION STUDIED A total of 277 children with moderate croup were enrolled from a pediatric emergency department of an academic medical center. Moderate croup was defined as hoarseness and barking cough associated with retractions or stridor at rest. Children with mild disease--barky cough only without retractions--or with severe croup--with cyanosis, severe retractions, or altered mental status--were excluded. Other exclusions were reactive airway exacerbation, epiglotitis, pneumonia, upper airway anomalies, immunosupression, recent steroids, or symptoms present for more than 48 hours. The mean age was 2 years; 69% were men. Eighty-five percent had the illness for more than 24 hours, and 66% had a fever. Thus, the patients seem similar to those seen in family practice offices, but more information about the referral pattern, socioeconomic status, diagnostic work-up, or clinical status would be very valuable in assessing the generalizability of this trial to nonacademic emergency department settings.

* STUDY DESIGN AND VALIDITY This was a single-blinded randomized controlled study. Patients were randomized to a single dose of dexamethasone (0.6 mg/kg, maximum dose 8 mg) administered either orally or intramuscularly (IM). The oral medication was administrated as a crushed tablet mixed with flavored syrup or jelly. Nurses and parents knew the treatment status; physicians assessing the child after treatment were unaware of the mode of administration. After discharge no routine follow-up appointment was given, but an investigator masked to treatment assignment telephoned caretakers at 48 to 72 hours after treatment to determine unscheduled returns for treatment and the child's clinical status. The sample size was calculated on the basis of a power of 0.8 to detect a 10% difference of return visits. Student t test and chi squares were used to analyze data; logistic regression was used to assess the impact of other variables.

Overall, the methodology of the study was solid. Strengths included randomization, adequate power, attempts to mask the physicians about the administration routes, and excellent follow-up. Weaknesses were relatively minor and include the lack of standardization of clinical examination and work-up, the use of parental report about return visits without any verification through medical records review, and the lack of information about the analysis, including the impact of potentially important confounding influences, such as smoking or other treatments.

* OUTCOMES MEASURED The primary outcome was parental report of return for further care after discharge. Unscheduled returns were defined as the subsequent need for additional steroids, racemic epinephrine, and/or hospitalization. A secondary outcome was the caregiver assessment of symptom improvement at 48 to 72 hours. Outcomes important for primary care providers were not measured, such as caretaker satisfaction with treatment; missed school, daycare, or work; or costs for parents or for the hospital.

* RESULTS The groups were similar at the outset. There were no statistically significant differences between patients receiving IM versus oral dexamethasone in unscheduled returns (32% vs 25%, respectively) or unscheduled return failures (8% vs 9%, respectively), and there was no difference in caretaker reports of symptomatic improvement. Only 1 of 138 children in the oral group had emesis. Patients receiving racemic epinephrine at the first visit were more likely to return, regardless of the route of dexamethasone administration.

RECOMMENDATIONS FOR CLINICAL PRACTICE

This study provides evidence that a single dose of dexamethasone (0.6 mg/kg, maximum dose 8 mg) given orally is as effective as injectable administration for the outpatient treatment of moderate croup. Oral dexamethasone given in a syrup or jelly is well tolerated. Clinicians should feel comfortable using either oral or IM dexamethasone to treat patients with moderate croup.

Warren Newton, MD MPH
University of North Carolina
Chapel Hill
E-mail: Warren_Newton@med.unc.edu