Laska 1983 Study 4.
Methods | Single‐centre, randomised, double‐blind, active‐controlled, parallel‐group study Single oral dose administered after 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 | Dental surgery: third molar removal N = 200 (173 in final analysed sample) |
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Interventions | Paracetamol 1000 mg + caffeine 130 mg, n = 45 Paracetamol 1000 mg, n = 46 Paracetamol 2000 mg + caffeine 260 mg, n = 40 Paracetamol 2000 mg, n = 42 Numbers of participants are those in final analysed sample Medications that might alter the response to the study analgesic during the study or in the 4 h preceding were prohibited. Participants who had taken caffeine during the 3 h before and after dosing were excluded |
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Outcomes | PI: standard 4‐point scale PR: standard 5‐point scale Withdrawals and dropouts |
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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) | Low risk | "sequentially assigned from individual packages prepared in random order" |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Test medication prepared to look exactly like the standard paracetamol 500 mg tablet. Equal numbers of tablets given to each group in any study |
Size | High risk | < 50 participants in relevant treatment arms |