Winter 1983.
Methods | Single‐centre, randomised, double‐blind, placebo‐controlled, parallel‐group study Single oral dose administered after the onset of moderate or severe pain Duration: 4 h, with assessments at baseline, 0.5, 1, 2, 3, and 4 h post dose |
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Participants | Oral surgery, including multiple bony impactions, single bony impaction, single tissue impaction, multiple tissue impactions, multiple extractions, alveolectomy, and difficult (complicated) extraction Participants were 16 to 75 years of age N = 167 (164 for efficacy) M 67, 97 Mean age 27 years |
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Interventions | Paracetamol 1000 mg + caffeine 130 mg, n = 40 for efficacy Paracetamol 1000 mg, n = 41 for efficacy Caffeine 130 mg, n = 42 for efficacy Placebo, n = 41 for efficacy No analgesic agent for ≥ 4 h before taking test medication |
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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) | 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 | "identically appearing 2‐capsule doses" |
Size | High risk | < 50 participants in relevant treatment arms |