Gries 2000.

Methods	A prospective, randomised, non‐blinded controlled clinical trial with blinded outcome assessors Comparison of single dose of IM dexamethasone versus oral prednisolone Randomization and allocation concealment were reported but methods were not discussed.
Participants	Patients with known history of asthma who presented to the ED with mild to moderate asthma exacerbation who did not require admission on presentation Asthma was defined as recurrent coughing, wheezing, or shortness of breath responsive to corticosteroids or β₂‐agonists. Asthma exacerbation was defined as increased asthma signs and symptoms unresponsive to the patient’s routine asthma medications and additional β₂‐agonist therapy. Clinical asthma score was defined as a composite score of wheeze and cough scores ranging from 0 to 8. Reported to enrolling patients with mild‐moderate exacerbations. Unable to assess exacerbation severity based on baseline PEF Ages: enrolled patients 6 months to 7 years. Mean age of IM corticosteroid group: 38 months (SD: 18). Mean age of oral corticosteroid group: 36 months (SD: 22) Patients were excluded from study if they received IV corticosteroids on the ED initial visit. Set in United States Sex: 23 men, 9 women
Interventions	Interventions: single IM dose of dexamethasone (˜ 1.7 mg/kg) versus oral prednisolone (˜ 2 mg/kg/day for 5 days, twice daily). No placebo treatment was provided. Co‐interventions in the ED: albuterol nebulization treatments. The use of systemic corticosteroids prior to enrolment were permitted (reported but not discussed). Co‐interventions at discharge: albuterol (2 mg/ml suspension, 100 µg/puff by meted‐dose inhaler, or 5% nebulizer solution) every 4 to 6 hours as needed
Outcomes	Primary outcomes: change in asthma signs or symptoms (clinical asthma score) from days 1 through 5 of treatment, number of patients whose clinical status returned to baseline by day 5, albuterol use, and tolerance of the corticosteroid medication Follow up days 3, 5, 7, 14, and 28 Relapse defined as within 14 days of resolution of the initial asthma exacerbation; the patient had another exacerbation requiring treatment with corticosteroids
Notes	Authors were not contacted. No registered protocol was identified.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	No information provided on how patients were randomised. Quote (p. 299): "Once enrolled in the study, patients were randomised to receive either a single IM dose of dexamethasone acetate (Dalalone, Forest Pharmaceuticals, 16 mg/mL) or prednisone (either suspension 3 mg/mL or tablets—patient’s choice) taken orally each day for 5 days."
Allocation concealment (selection bias)	Unclear risk	No information on allocation concealment provided.
Blinding of participants and personnel (performance bias) All outcomes	High risk	Non‐blinded study. Quote (p. 300‐1): "The study investigators were blinded to the patient’s treatment arm. Patients and parents were not blinded. The nurses in the paediatric clinic who administered the IM injections did not discuss the patients with the study investigators." "Investigator blinding was achieved in all but 4 patients. For 2 of these children, the nurses told an investigator that they had administered a shot, and the other 2 children disclosed what they had received (one IM Dex and one oral Pred). A second investigator, who was still blinded, completed the assessments."
Blinding of outcome assessment (detection bias) All outcomes	Low risk	Outcome assessors were blinded to group assignment. Quote (p. 300): "The study investigators were blinded to the patient’s treatment arm"
Incomplete outcome data (attrition bias) All outcomes	Low risk	Study attrition provided. Excluded patients balanced between groups. Quote: (p. 300): "From September 1996 through February 1997, we approached 35 children (age range, 8 months to 7 years) and their legal guardians concerning enrolment, and all but 2 agreed to participate in the study. Sixteen children received IM Dex, and 17 were randomised to receive oral Pred. One child, a 16‐month‐old (randomised to IM Dex), was withdrawn on her second study day for treatment of a persistent cough by an emergency department physician who noted no wheezing or respiratory distress but gave her an additional IM injection of dexamethasone."
Selective reporting (reporting bias)	Unclear risk	No protocol available.
Other bias	Unclear risk	No source of funding provided.