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

Rapanos 1999.

Methods

  • Study design: parallel RCT

  • Study duration: not reported

  • Study follow‐up: 24 h post‐operatively
Participants

  • Country: Canada

  • Setting: single centre

  • Inclusion criteria: adults undergoing elective aortocoronary bypass surgery

  • Number: treatment group (31); control group (26)

  • Median age ± SD (years): treatment group (62.2 ± 9.5); control group (59.4 ± 9.4)

  • Sex (M/F): treatment group (25/6); control group (20/6)

  • Exclusion criteria: previous history of peptic ulcer or GI bleeding; hepatic or kidney insufficiency; insulin dependent DM; known allergy to aspirin or NSAIDs; use of aspirin in the 5 days prior to surgery; gastro‐epiploic artery conduit; weight < 60 kg; inability to operate patient controlled analgesia device
Interventions Treatment group

  • Indomethacin: 100 mg suppository 2 to 3 h after surgery and again 12 h later


Control group

  • Placebo: suppository 2 to 3 h after surgery and again 12 h later
Outcomes

  • Pre‐operative and post‐operative SCr
Notes

  • Funding source: Technilab Inc. supplied study drugs, without any financial support

  • 125 patients were consented and enrolled in the study preoperatively. Fifty‐five patients were excluded post‐operatively due to excessive blood loss. A further 10 patients were excluded due to protocol violations

  • A very healthy subgroup was studied
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Randomisation carried out by pharmacy department
Allocation concealment (selection bias) Low risk Sequential selection of previously randomised envelopes; envelopes containing study drug or placebo
Blinding of participants and personnel (performance bias) 
 All outcomes Low risk Study drugs and placebo suppositories in envelopes appearing similar
Blinding of outcome assessment (detection bias) 
 All outcomes Unclear risk Study drugs and placebo suppositories in envelopes appearing similar
Incomplete outcome data (attrition bias) 
 All outcomes Low risk Reasons for missing outcome data unlikely to be related to true outcome
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