McQuay 1996.
Methods | Single‐centre, randomised, double‐blind, placebo‐controlled, parallel‐group study Single oral dose administered after onset of moderate or severe pain Duration: 8 h, with first 2 h in hospital. Time points of individual assessments not reported |
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Participants | Dental surgery: third molar removal N = 164 (161 for efficacy) M 59, F 102 Mean age 25 years |
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Interventions | Ibuprofen 200 mg + caffeine 50 mg, n = 30 for efficacy Ibuprofen 200 mg + caffeine 100 mg, n = 30 for efficacy Ibuprofen 200 mg + caffeine 200 mg, n = 29 for efficacy Ibuprofen 200 mg, n = 31 for efficacy Ibuprofen 400 mg, n = 30 for efficacy Placebo, n = 11 for efficacy No caffeine‐containing products from midnight on the evening before surgery and no other analgesics in the 12 h before surgery |
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Outcomes | PI: standard 4‐point scale, an 8‐word scale (randomly placed words ranging from 'no pain' to 'excruciating', scored 0 to 7), and a 100 mm VAS PR: standard 5‐point scale and a 100 mm VAS 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 | Randomised using a random number computer program |
Allocation concealment (selection bias) | Low risk | Remote packaging, labelled only with treatment number |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | "identical matching capsules" |
Size | High risk | < 50 participants in relevant treatment arms |