Soleimani 2013.
Methods | Randomised single‐blind controlled trial | |
Participants |
Study period: January 2009 to March 2010 Setting: emergency department at Ali‐Ebne Abitaleb Hospital, Iran Inclusion criteria: children aged 6 months to 6 years admitted to the emergency department with barking cough, stridor, hoarseness, and respiratory distress Exclusion criteria: chronic pulmonary disease; severe croup (croup score > 7); recurrent croup; allergy to corticosteroids; contraindication of corticosteroid (history of tuberous sclerosis, history of varicella infection during the past 3 weeks); history of corticosteroid administration during the last 4 weeks; foreign body; epiglottitis; bacterial tracheitis; immune deficiency Baseline demographics (N = 68): proportion males: 53% mean (SD) age in months: 26.3 (1.5) mean (SD) croup score: treatment 1: 1.81 (0.59); treatment 2: 2.03 (0.47) |
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Interventions | Treatment 1 (N = 36): single dose 0.60 mg/kg intramuscular dexamethasone Treatment 2 (N = 32): single dose 0.60 mg/kg oral dexamethasone |
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Outcomes | Return visits or (re)admissions or both | |
Notes | Not indexed in the databases searched (located via a search of Google.ca); funding source: Zahedan University of Medical Sciences, Zahedan, Iran | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Comment: described as "randomly divided"; unclear how the randomisation sequence was generated |
Allocation concealment (selection bias) | Unclear risk | Comment: insufficient information provided to judge. |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Comment: participants and personnel were not blinded. Treatments were clearly distinguishable. |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Comment: outcome assessor described as blinded. Unclear how they were blinded and if the blinding could have been broken |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Comment: 15% loss to follow‐up; unclear from which group children were lost. No intention‐to‐treat analysis |
Selective reporting (reporting bias) | Unclear risk | Comment: no protocol identified. All prespecified outcomes from methods appear in results. |
Other bias | Low risk | Comment: no other sources of bias identified. |
Overall risk of bias All outcomes | High risk | Comment: at least 1 domain judged as high risk. |