Giannini 1990.
| Methods | ||
| Participants | ||
| Interventions |
Intervention group (N = 45): ibuprofen suspension (concentration 100 mg/5 mL) + placebo aspirin Control group (N = 47): aspirin 200 mg tablet (participant weight 10 to 30 kg) or 300 mg capsules (participant weight > 30 kg) + placebo ibuprofen Week 2: physician's option to increase dose to 40 mg/kg/day ibuprofen or 80 mg/kg/day aspirin, provided no significant side effects Study duration: 12 weeks |
|
| Outcomes | ||
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Quote: "patients were randomly assigned, in random blocks of four within each centre, to receive ibuprofen or aspirin" |
| Allocation concealment (selection bias) | Unclear risk |
Quote: "patients were assigned numbers sequentially, on the basis of body weight, from blocks of numbers allotted to each site" Quote: "Before initiation of this trial, each centre was given a list of consecutive numbers from Boots Pharamceuticals. Patients were assigned numbers in the sequence in which they entered the study" Quote: "Patients received one of the two active medications plus a dummy of the alternative agent" |
| Blinding of participants and personnel (performance bias) All outcomes | High risk |
Quote: "Patients received one of the two active medications plus a dummy of the alternative agent" Comment: The study personnel would have known what they were giving the participants (as one was a liquid and the other was a tablet). |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Comment: Insufficient information |
| Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Comment: All participants were accounted for. Lost to follow‐up and withdrawals explained. However, authors do not report whether there were significant differences between completers and non‐completers. |
| Selective reporting (reporting bias) | Low risk | Comment: All planned outcomes from the methods were reported in the results. |
| Size | High risk | Comment: Total participants = 92 (< 50 per treatment arm) |
| Other bias | Low risk | Comment: No other potential sources of bias found. |