| Methods |
Double‐blind randomised, placebo‐controlled trial.
Computer‐generated randomisation schedule. Medications prepared by hospital pharmacy and appeared identical.
Sample size calculated.
Intention‐to‐treat analysis. |
| Participants |
98 patients undergoing elective coronary artery bypass graft.
Exclusions: left ventricle ejection fraction < 20%, serum creatinine > 130 μmol/L, preoperative use of H2 antagonists, proton pump inhibitors, steroids, NSAIDs (with exception of aspirin), narcotics or illicit drugs, a history of peptic ulcer, liver disease or NSAID allergy. |
| Interventions |
Rx: naproxen 500 mg rectal suppository within 1 hour after arrival in the recovery room, then every 12 hours for a total of 5 doses; followed by naproxen 250 mg orally three times a day for 2 days.
Pl: placebo suppositories and placebo tablets administered in a similar way as the treatment group. |
| Outcomes |
Pre‐operative and post‐operative serum creatinine, inotropic use for renal dysfunction. |
| Notes |
Unpublished Day 1 and Day 2 serum creatinine and inotropic use requested from authors. 7 did not receive naproxen because of prolonged cardiopulmonary bypass time, perioperative stroke, anorexia and protocol violations. 9 did not receive placebo because of cardiac arrest, perioperative myocardial infarction, elevated baseline creatinine, excessive chest tube output and protocol violations. |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Allocation concealment (selection bias) |
Low risk |
A ‐ Adequate |
