Forbes 1990.
Methods | Multicentre, randomised, double‐blind, placebo‐controlled, parallel‐group study, with a single oral dose administered at the onset of steady moderate or severe pain Duration: 6 h, with assessments at baseline, 1, 2, 3, 4, 5, and 6 h post dose |
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Participants | Dental surgery: third molar removal Patients were ≥ 15 years of age N = 401 (350 for efficacy) M 147, F 203 Mean age 21 years |
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Interventions | Aspirin 650 mg + caffeine 65 mg, n = 66 for efficacy Aspirin 650 mg, n = 68 for efficacy Aspirin 1000 mg, n = 71 for efficacy Caffeine 65 mg, n = 70 for efficacy Placebo, n = 75 for efficacy |
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Outcomes | PI: standard 4‐point scale PR: standard 5‐point scale PGE: standard 5‐point scale Withdrawals and dropouts Serious adverse events |
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Notes | Oxford Quality Score: R2, DB2, W1. Total = 5/5 | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Computer‐generated randomisation schedule |
Allocation concealment (selection bias) | Unclear risk | Method not described |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | "all tablets were identical in appearance" |
Size | Unclear risk | 50 to 200 participants in relevant treatment arms |