Skip to main content
. 2018 Nov 29;2018(11):CD011274. doi: 10.1002/14651858.CD011274.pub2

Hynninen 2000.

Methods
  • Study design: parallel RCT

  • Study duration: not reported

  • Study follow‐up: 24 h

Participants
  • Country: Canada

  • Setting: inpatient

  • Inclusion criteria: patients undergoing coronary artery bypass graft surgery were randomised.

  • Number: treatment group 1 (28); treatment group 2 (28); treatment group 3 (27); control group (31)

  • Mean age ± SD (years): treatment group 1 (59 ± 9); treatment group 2 (60 ± 7); treatment group 3 (58 ± 9); control group (55 ± 9)

  • Sex (M/F): treatment group 1 (20/8); treatment group 2 (24/4); treatment group 3 (21/6); control group (28/3)

  • Exclusion criteria: ejection fraction < 20%; previous cardiac surgery; insulin‐dependent DM; weight > 100 kg or < 60 kg; kidney insufficiency (SCr > 130 μmol/L); allergy to propofol, morphine or NSAID; active peptic ulcer disease; history of GI bleeding; age > 75 years; warfarin, dipyridamole or heparin therapy preoperatively

Interventions Treatment group 1
  • Diclofenac: 75 mg suppository twice/d after surgery


Treatment group 2
  • Ketoprofen: 100 mg suppository twice/d after surgery


Treatment group 3
  • Indomethacin: 100 mg suppository twice/d after surgery


Control group
  • Placebo suppository twice/d after surgery

Outcomes
  • Pre‐operative and post‐operative SCr

Notes
  • 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) Low risk Randomisation and preparation of study drug in identically shaped suppositories was done by hospital pharmacy
Blinding of participants and personnel (performance bias) 
 All outcomes Low risk Randomisation and preparation of study drug in identically shaped suppositories was done by hospital pharmacy
Blinding of outcome assessment (detection bias) 
 All outcomes Unclear risk Insufficient information to permit judgement
Incomplete outcome data (attrition bias) 
 All outcomes Low risk 6/114 patients withdrawn. Of these six patients, 1 patient was withdrawn after one dose of indomethacin because of SCr increase > 20% post‐operatively. This patient did not receive further NSAIDs as per protocol and was not included in the post‐operative outcome table. This event was mentioned in the discussion of the paper. The plausible effect size of this one event is probably not enough to have a clinically relevant impact on observed effect size
Selective reporting (reporting bias) Low risk Study protocol matches outcomes presented
Other bias Unclear risk Insufficient information to permit judgement