Forbes 1991.
Methods | Multicentre, randomised, double‐blind, placebo‐controlled, parallel‐group study, with a single oral dose administered at the onset of moderate or severe pain Duration: 8 h, with assessments at baseline, 0.5, 1, 2, 3, 4, 5, 6, 7, and 8 h post dose |
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Participants | Dental surgery: third molar removal Patients were at least 15 years of age N = 362 (298 for efficacy) M 121, F 177 Mean age 22 years |
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Interventions | Ibuprofen 100 mg + caffeine 100 mg, n = 49 for efficacy Ibuprofen 100 mg, n = 49 for efficacy Ibuprofen 200 mg + caffeine 100 mg, n = 44 for efficacy Ibuprofen 200 mg, n = 48 for efficacy Ibuprofen 50 mg, n = 57 for efficacy Placebo, n = 51 for efficacy Caffeine‐containing foods and beverages were prohibited for 4 h before taking study medication and for the following 8‐h study period |
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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: R1, DB2, W1. Total = 4/5 | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Gives reference to methods in earlier reports that are low risk |
Allocation concealment (selection bias) | Unclear risk | Method not described |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | "identically appearing capsules" |
Size | High risk | < 50 participants in relevant treatment groups |