Vidal 1999.

Methods	RCT, DB, single and multiple oral dose phases, 4 parallel groups. Medication administered when baseline pain was of severe intensity. Pain assessed at 0, 15, 30, 45 min, and 1, 2, 3, 4, 5, 6 h for single dose phase.
Participants	Hallux vagus (bunion) surgery. N = 188 (172 analysed). M 25, F 163. Mean age: 54 years.
Interventions	Dexketoprofen trometamol 12.5 mg, n = 47. Dexketoprofen trometamol 25 mg, n = 47. Ketoprofen 50 mg, n = 47. Placebo, n = 47.
Outcomes	PI: 100‐mm VAS and standard 4‐point scale. PR: standard 5‐point scale. PGE: non‐standard 4‐point scale. Time to use of rescue medication. Number using rescue medication. Withdrawals.
Notes	Oxford Quality Score: R2, DB2, W1. Rescue medication via PCA morphine.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Randomisation "by computer program" for each centre.
Allocation concealment (selection bias)	Low risk	Generation of sequence, and preparation of code envelopes and study medication performed by third party; allocation "in chronological order of inclusion in each centre".
Blinding of participants and personnel (performance bias) All outcomes	Low risk	"All the treatments .... were tablets of identical size, colour and weight".
Blinding of outcome assessment (detection bias) All outcomes	Low risk	"All the treatments .... were tablets of identical size, colour and weight".
Size	High risk	< 50 participants per treatment arm.

AE: adverse event; DB: double blind; F: female; h: hour; M: male; min: minute; N: number of participants in study; n: number of participants in treatment arm; PCA: patient‐controlled analgesia; PGE: Patient Global Evaluation of efficacy; PI: pain intensity; PR: pain relief; R: randomised (Oxford Quality Score); RCT: randomised controlled trial; VAS: visual analogue scale (see 'Glossary'; Appendix 4); VRS: verbal rating scale; W: withdrawal (Oxford Quality Score).