Ott 2003.

Methods	Study design: parallel RCT Study duration: January and May 2000 Study follow‐up:14 POD
Participants	Countries: USA, Canada, Germany, UK Setting: multicentre (58) Inclusion criteria: patients undergoing coronary artery bypass graft surgery. Number: treatment group (311); control group (151) Mean age ± SD (years): treatment group (60.3 ± 8.2); control group (61.3 ± 8.0) Sex (M/F): treatment group (265/46); control group (135/16) Exclusion criteria: patients undergoing emergency surgery and those with a recent (48 h) MI; insulin‐dependent or uncontrolled diabetes; increased concentrations of liver enzymes SCr > 1.5 mg/dL (or 133 µmol/L); any coagulopathy; stroke or transient ischaemic attack within 6 months; substance abuse (opioids, any other analgesics, or alcohol); allergy to NSAIDs; history of gastric or duodenal ulcer; intra‐operative complications
Interventions	Treatment group Parecoxib: 40 mg IV was administered within 30 min after extubation and every 12 h for a minimum of 3 days. Subsequently, oral valdecoxib at a dose of 40 mg every 12 h was initiated and administered for a combined total of 14 days Control group IV placebo: administered within 30 min after extubation and every 12 h for a minimum of 3 days. Subsequently, oral placebo every 12 h was initiated and administered for a combined total of 14 days
Outcomes	SCr Clinical adverse outcomes
Notes	A typing error was found in the presentation of results on page 1485 (an increase in creatinine of 0.7 mg/dL is equivalent to 62 µmol/L, instead of 0.62 µmol/L as quoted in the text). Note: creatinine rise as cause for withdrawal was 1.9% vs 1.3% in treatment vs placebo group Funding source: not reported
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Study was described as randomised, method of randomisation was not reported
Allocation concealment (selection bias)	Unclear risk	Insufficient information to permit judgement
Blinding of participants and personnel (performance bias) All outcomes	Unclear risk	Insufficient information to permit judgement
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	Insufficient information to permit judgement
Incomplete outcome data (attrition bias) All outcomes	High risk	After randomisation and the administration of at least one dose of the study drug, 26% of the 462 patients (equally distributed between groups) were withdrawn from the study. Most frequent reason for withdrawal was an adverse event (15.6%) of which 1.3% in the control group and 1.9% in the NSAID group were due to rise in creatinine. Plausible effect size among missing outcomes enough to induce clinically relevant bias in observed effect size
Selective reporting (reporting bias)	Low risk	Study protocol matches outcomes presented
Other bias	Unclear risk	Insufficient information to permit judgement