Bernard 1999.
Methods | RCT, 13/59 withdrawals | |
Participants | USA: 59 children, aged 1 to 10 years, with cough 1 to 14 days (median 4 days), respiratory rate less than 35 and normal lung exam | |
Interventions | Albuterol syrup (0.1 mg/kg to max dose of 2 mg every 8 hours) (N = 30); versus placebo syrup (N = 29) for 7 days | |
Outcomes | Daily cough impact score, number with complete resolution of cough at trial end; number with daily cough; number with hyperactivity or shaking | |
Notes | Prohibited codeine, dextromethorphan, antihistamines, OTC cough preparations; 27% of albuterol group and 38% of placebo group treated with antibiotics for co‐existing otitis media Study medication was provided by a pharmaceutical company |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Participants were described as "randomized in blocks of 4" but no details were provided about the method of sequence generation |
Allocation concealment (selection bias) | Low risk | "Investigators ... were blinded to group assignment until the trial was completed" |
Blinding (performance bias and detection bias) All outcomes | Unclear risk | Participants and personnel were described as blinded, but no details were provided about the methods used. Children receiving the active treatment were more likely to develop shaking (a known side effect of the intervention), so it is possible that study personnel, parents, or care providers may have become aware of the treatment assignment in some cases. Outcome assessment was done with a telephone interview asking parents to assess symptoms |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Dropout rates were provided and an ITT analysis was carried out |
Selective reporting (reporting bias) | Low risk | No positive outcomes were reported |