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

Sunshine 1996.

Methods Single‐centre, randomised, double‐blind, placebo‐controlled, parallel‐group study
Single oral dose administered after the onset of severe pain
Duration: 6 h, with assessments at baseline, 0.5, 1, 2, 3, 4, 5, and 6 h post dose
Participants Postepisiotomy pain
Participants aged 18 years or older
N = 305 (302 for efficacy)
All F
Mean age 24 years
Interventions Ibuprofen 100 mg + caffeine 100 mg, n = 50
Ibuprofen 100 mg, n = 51
Ibuprofen 200 mg + caffeine 100 mg, n = 50
Ibuprofen 200 mg, n = 50
Ibuprofen 50 mg, n = 51
Placebo, n = 50
No medications that might confound the interpretation of efficacy, or caffeine‐containing food and beverages were permitted during the 6 h before and after dosing
Outcomes PI: standard 4‐point scale
PR: standard 5‐point scale
PGE: 4‐point categorical scale (0 = poor, 1 = fair, 2 = good, 3 = excellent)
Withdrawals and dropouts
Serious adverse events
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) Unclear risk Method not described
Blinding of participants and personnel (performance bias) 
 All outcomes Low risk "All medications were dispensed as capsules"
Size High risk All relevant treatment groups borderline at 50 or 51 participants each