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. 2018 Nov 29;2018(11):CD011274. doi: 10.1002/14651858.CD011274.pub2

NAFARM 2011.

Methods
  • Study design: parallel RCT

  • Study duration: 2005 to 2009

  • Study follow‐up: until hospital discharge

Participants
  • Country: Brazil

  • Setting: single centre

  • Inclusion criteria: patients undergoing coronary artery bypass graft surgery

  • Number: treatment group (82); control group (79)

  • Mean age ± SD (years): treatment group (59.7 ± 9.8); control group (58.0 ± 8.6)

  • Sex (M/F): treatment group (50/32); control group (52/27)

  • Exclusion criteria: allergies to study medication; pregnant; off‐pump surgery; history of GI bleeding; chronic liver disease; kidney insufficiency (SCr > 132.6 mol/L); thrombocytopenia; reported preoperative use of glucocorticoids; previous diagnosis of atrial fibrillation

Interventions Treatment group
  • Naproxen: 275 mg twice/d for 5 days from the moment the patients returned to the ICU post surgery


Control group
  • Placebo: twice/d for 5 days from the moment the patients returned to the ICU post surgery

Outcomes
  • Kidney failure (SCr elevation ≥ 50% from baseline)

  • Death

  • Length of hospital stay

Notes
  • Funding source: no funding received

Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk "The pharmacist made the randomization list and allocated the placebo and naproxen pills without the knowledge of any other person"
Allocation concealment (selection bias) Low risk Sealed envelope, medication appears identical, nursing staff giving out drugs are not part of the investigation team
Blinding of participants and personnel (performance bias) 
 All outcomes Low risk Sealed envelope, medication appears identical, nursing staff giving out drugs are not part of the investigation team
Blinding of outcome assessment (detection bias) 
 All outcomes Low risk Sealed envelope, medication appears identical, nursing staff giving out drugs are not part of the investigation team
Incomplete outcome data (attrition bias) 
 All outcomes Low risk Results of all 161 randomised patients reported for primary and secondary outcomes
Selective reporting (reporting bias) Low risk Study protocol matches outcomes presented
Other bias Low risk The study appears to be free of other sources of bias