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 Eight‐hour study period, with assessments at baseline, 0.5, one, two, three, four, five, six, seven, and eight hours post‐dose |
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Participants | Dental surgery ‐ third molar removal Caffeine‐containing foods and beverages were prohibited for four hours before taking study medication and for the following 8‐hour study period 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 |
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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 | |
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 | Not reported |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | "identically appearing capsules" |
Size | Low risk | < 50 participants in relevant treatment groups |