Garbutt 2013.
Methods | Randomised double‐blind controlled trial | |
Participants |
Study period: 26 October 2009 to 16 April 2010 and 6 September 2010 to 29 April 2011 Setting: 10 offices of primary care practitioners in St Louis, MO, USA Inclusion criteria: children aged 1 to 8 years with croup symptoms for ≤ 48 hours and a clinical diagnosis of mild or moderate croup at an office visit, based on symptoms in the past 24 to 36 hours Exclusion criteria: diagnosis of severe croup or impending respiratory failure; prior treatment with epinephrine or oral corticosteroids for this croup episode; symptoms or signs suggesting other cause of stridor; chronic respiratory disease including asthma; known contraindication to steroid use; parent not in the same household as the child in the subsequent 4 days, could not participate in telephone interviews, or was not English speaking Baseline demographics (N = 87): proportion male: treatment: 61%; comparator: 68% mean (SD) age in years: treatment: 2.67 (1.43); comparator: 3.11 (1.58) mean (SD) Westley croup score: treatment : 0.4 (0.7); comparator: 0.6 (0.8) mean (SD) Telephone Outpatient Score: treatment: 2.2 (0.9); comparator: 2.0 (0.9) |
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Interventions | Treatment (N = 41): single 2 mg/kg (maximum 60 mg/day) dose of oral prednisolone once per day for 3 days Comparator (N = 46): single 0.60 mg/kg (maximum 18 mg) dose of oral dexamethasone, followed by 2 days of placebo comparable in appearance, smell, and taste |
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Outcomes | Additional health care for croup within 11 days of randomisation | |
Notes | Funding source: National Center for Research Resources (National Institutes of Health); National Institutes of Health Roadmap for Medical Research | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "randomized blocks were used to assign subjects to treatment groups, with randomization stratified by site. Computer generated random numbers determined how the two treatments were allocated" |
Allocation concealment (selection bias) | Low risk | Quote: "Study drug packages were prepared offsite by the pharmacist" "The pharmacist... packaged the bottles in a sealed opaque envelope" "For allocation concealment, the drug formulation ensured the volume of the weight‐based dose was equivalent for each medication." |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Quote: "The pharmacist... packaged the bottles in a sealed opaque envelope" "comparable in appearance, smell and taste" "patients, parents, PCPs, and study team members were blinded to treatment assignments" |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Quote: "The pharmacist... packaged the bottles in a sealed opaque envelope" "comparable in appearance, smell and taste" "patients, parents, PCPs, and study team members were blinded to treatment assignments" |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Comment: intention‐to‐treat analysis used. Losses to follow‐up on days 1, 2, 3, 4, and 11 were 7%, 9%, 9%, 3%, and 2% (non‐cumulative). Participation in follow‐up interviews was balanced between groups. |
Selective reporting (reporting bias) | Low risk | Comment: no deviations from protocol detected. |
Other bias | Low risk | Comment: no other sources of bias identified. |
Overall risk of bias All outcomes | Low risk | Comment: all domains judged as low risk. |