Sunshine 1996.
Methods | Single‐centre, randomised, double‐blind, placebo‐controlled, parallel‐group study Single oral dose administered after the onset of severe pain Duration: 6 h, with assessments at baseline, 0.5, 1, 2, 3, 4, 5, and 6 h post dose |
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Participants | Postepisiotomy pain Participants aged 18 years or older N = 305 (302 for efficacy) All F Mean age 24 years |
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Interventions | Ibuprofen 100 mg + caffeine 100 mg, n = 50 Ibuprofen 100 mg, n = 51 Ibuprofen 200 mg + caffeine 100 mg, n = 50 Ibuprofen 200 mg, n = 50 Ibuprofen 50 mg, n = 51 Placebo, n = 50 No medications that might confound the interpretation of efficacy, or caffeine‐containing food and beverages were permitted during the 6 h before and after dosing |
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Outcomes | PI: standard 4‐point scale PR: standard 5‐point scale PGE: 4‐point categorical scale (0 = poor, 1 = fair, 2 = good, 3 = excellent) 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) | Unclear risk | Method used to generate random sequence not described |
Allocation concealment (selection bias) | Unclear risk | Method not described |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | "All medications were dispensed as capsules" |
Size | High risk | All relevant treatment groups borderline at 50 or 51 participants each |