Sample size was determined assuming an equal allocation ratio between the groups, a type 1 error of 0.05, an excess of risk of 20% assuming a baseline adverse symptom prevalence of 5%, and a desired power of 80%.7Patients enrolled in the study were given one of two different doses of oral steroids using a random allocation chart based on a table of random numbers.8 The randomization code was held by the nursing staff at the asthma center. Group 1 received a 5-day course of prednisone or prednisolone, 1 mg/kg/d bid, and group 2 received a 5-day course of prednisone or prednisolone, 2 mg/kg/d bid, up to a maximum of 60 mg/d prescribed by a resident physician or nurse practitioner. The parents, principal investigator, and primary care physician were not told which dose of oral steroids the child was receiving. Information obtained included age, sex, racial background, and current medications, including the dose, frequency, and method of administration of β-adrenergic agents and inhaled steroids and the presence of any side effects from them. Participants were asked whether systemic symptoms associated with a viral upper respiratory infection, such as headache, nasal congestion, running nose, and fever, were present. At the end of the 5-day course, the parents responded to a questionnaire by the principal investigator (SK) via telephone, mentioning the most common reported side effects of oral steroids (Table 1
). The parents were asked specifically whether any of the side-effect symptoms were present before the patient began receiving oral steroids. Responses were considered positive only if the symptoms were absent prior to the initiation of steroid therapy. As anxiety, hyperactivity, and short attention span could also follow the use of β-adrenergic agents, we considered a response to be positive only if the symptom was present for ≥ 4 h after the last dose of albuterol was given. Also, we asked about any associated systemic symptoms. Finally, we asked whether the asthma symptoms (cough, shortness of breath, and wheeze) had resolved at the end of treatment with oral steroids.