Eboriadou 2010.
Methods | Randomised double‐blinded controlled trial | |
Participants |
Study period: January 2000 to December 2001 Setting: emergency department at a hospital in Greece Inclusion criteria: children aged 6 months to 5 years presenting to the emergency department with a clinical diagnosis of viral croup by a history of a short period of viral upper respiratory symptoms followed by hoarseness or barking cough and clinical evidence of hoarseness, barking cough, or stridor in the emergency department; modified Downes and Raphaelly croup score ≥ 2; could be managed as outpatients Exclusion criteria: known structural airways anomalies; acute epiglottitis; bacterial tracheitis; pneumonia; foreign body aspiration or past history of laryngoscopy; history of prior intubation; chronic airway obstruction; received steroids in the past 24 hours; required more than 1 treatment with nebulised L‐epinephrine or hospitalisation Baseline characteristics (N = 64): proportion males: treatment 1: 80%; treatment 2: 58%; treatment 3: 65% mean age in years: treatment 1: 2.6; treatment 2: 3.2; treatment 3: 3.4 mean modified Downes and Raphaelly croup score: treatment 1: 5.13; treatment 2: 5.89; treatment 3: 3.95 |
|
Interventions | Treatment 1 (N = 25): single 5 mL (1:1000 mg/mL) dose of nebulised L‐epinephrine via nebuliser with oxygen at a rate of 5 L/minute Treatment 2 (N = 19): single 0.60 mg/kg (maximum 8 mg) dose of intramuscular dexamethasone Treatment 3 (N = 20): single 200 µg dose of inhaled beclomethasone dipropionate delivered via AeroChamber device Supplemental oxygen was used for children with oxygen saturation values < 95%. |
|
Outcomes | Change in modified Downes and Raphaelly croup score from baseline to 2 hours; return visits to the emergency department | |
Notes | Funding source: not reported | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "patients were assigned by a random numbers table to receive..." |
Allocation concealment (selection bias) | Unclear risk | Comment: insufficient information provided to judge. |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Comment: described as "double‐blind", though the interventions were clearly distinguishable, and the mechanism of blinding was not described |
Blinding of outcome assessment (detection bias) All outcomes | High risk | Comment: no description of a third‐party outcome assessor. Carried over judgement from blinding of participants and personnel |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Comment: no missing outcome data |
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. |