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

Fayaz 2004.

Methods
  • Study design: parallel RCT

  • Study duration: not reported

  • Study follow‐up: 24 h

Participants
  • Country: UK

  • Setting: single centre

  • Inclusion criteria: patients undergoing coronary artery bypass graft surgery

  • Number: treatment group 1 (17); treatment group 2 (17); control group (20)

  • Mean age ± SD (years): treatment group 1 (59.4 ± 8.4); treatment group 2 (64.0 ± 8.4); control group (64.3 ± 7.9)

  • Sex (M/F): treatment group 1 (9/7); treatment group 2 (11/6); control group (9/9)

  • Exclusion criteria: previous history of peptic ulcer disease or GI bleeding; hepatic and/or kidney insufficiency (SCr > 120 μmol/L); insulin‐dependent DM; left ventricular ejection fraction 30%; weight > 110 kg or < 55 kg; known allergy to study drugs.

  • Post‐operative exclusion criteria: patients with prolonged cardiopulmonary bypass (180 min), patients requiring intra‐aortic balloon pump support, patients who had excessive post‐operative bleeding 150 mL/h for the first 2 h, and patients with early post‐operative SCr increase (20% of baseline)

Interventions Treatment group 1
  • Diclofenac: 100 mg

  • Paracetamol: 1 g

  • Suppositories were administered 2 h after surgery. Diclofenac was repeated after 18 h and paracetamol every 6 h for 24 h


Treatment group 2
  • Diclofenac: 100 mg, 2 and 18 h after surgery


Control Group
  • Placebo suppositories: 2 at same time as treatment group 1

Outcomes
  • SCr

Notes
  • Funding source: not reported

Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk "The randomization code was computer generated by Lab View version 2"
Allocation concealment (selection bias) Low risk Insufficient information to permit judgement
Blinding of participants and personnel (performance bias) 
 All outcomes Low risk Drugs made up by pharmacist
Blinding of outcome assessment (detection bias) 
 All outcomes Unclear risk Insufficient information to permit judgement
Incomplete outcome data (attrition bias) 
 All outcomes High risk 6/60 patients withdrawn. Equally distributed across study groups and similar reasons for withdrawal given. 2 patients were withdrawn before entering the study due to oliguria and an early post‐operative SCr rise (> 20% from baseline)
Selective reporting (reporting bias) Low risk Study protocol matches outcomes presented
Other bias Unclear risk Insufficient information to permit judgement