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. 2014 Dec 11;2014(12):CD009281. doi: 10.1002/14651858.CD009281.pub3

Laska 1983 Study 2.

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
Participants Postpartum pain: postepisiotomy, postsurgical, or uterine cramping
N = 577 (434 in final analysed sample)
No further participant characteristics reported
Interventions Paracetamol 500 mg + caffeine 65 mg, n = 62
Paracetamol 500 mg, n = 68
Paracetamol 1000 mg + caffeine 130 mg, n = 62
Paracetamol 1000 mg, n = 68
Paracetamol 1500 mg + caffeine 195 mg, n = 64
Paracetamol 1500 mg, n = 66
Placebo, n = 44
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
Outcomes PI: standard 4‐point scale
PR: standard 5‐point scale
Withdrawals and dropouts
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