Laska 1983 Study 3.
Methods | Single‐centre, randomised, double‐blind, placebo‐controlled, parallel‐group study Single oral dose administered after onset of moderate or severe pain Almost identical protocols for Studies 1, 2, 3 Duration: 4 h, with assessments baseline, 0.5, 1, 2, 3, and 4 h post dose |
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Participants | Postpartum pain: postepisiotomy or postsurgical N = 552 (538 in final analysed sample) |
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Interventions | Paracetamol 500 mg + caffeine 65 mg, n = 80 Paracetamol 500 mg, n = 81 Paracetamol 1000 mg + caffeine 130 mg, n = 78 Paracetamol 1000 mg, n = 81 Paracetamol 1500 mg + caffeine 195 mg, n = 80 Paracetamol 1500 mg, n = 81 Placebo, n = 57 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 = 4/5 | |
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) | 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 | Unclear risk | 50 to 200 participants in relevant treatment arms |