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

Immer 2003.

Methods

  • Study design: parallel RCT

  • Study duration: June 2000 to October 2000

  • Study follow‐up: until hospital discharge
Participants

  • Country: Switzerland

  • Setting: single centre

  • Inclusion criteria: patients undergoing coronary artery bypass operation

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

  • Mean age ± SD (years): treatment group 1 (56.6 ± 8.8); treatment group 2 (60.5 ± 6.1); control group (60.5 ± 8.5)

  • Sex (M/F): treatment group 1 (3/17); treatment group 2 (3/17); control group (5/15)

  • Exclusion criteria: > 70 years; left ventricular ejection fraction < 30%; previous history of peptic ulcer disease or GI bleeding; hepatic or kidney insufficiency; known allergy to tramadol or NSAIDs and preoperative analgesic treatment

  • Post‐operative period exclusion criteria: delayed transfer to the general ward; SCr more than 150 μmol/L, and altered mental status
Interventions Treatment group 1

  • Diclofenac: 50 mg every 8 h orally on POD 2 and 3


Treatment group 2

  • Etodolac: 300 mg every 8 h orally on POD 2 and 3


Control group

  • Tramadol: slow‐release (150 mg every 12 h orally)
Outcomes

  • Pre‐operative and post‐operative SCr
Notes

  • Tramadol group (weak opioid) not included in analysis

  • POD 1 SCr data not included as study drugs were not given

  • CrCl measured on POD 4

  • Funding Source: Study drugs were supplied by Grunenthal, Novartis Pharma and Sigma‐Tau, Switzerland
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) Unclear risk Insufficient information to permit judgement
Blinding of participants and personnel (performance bias) 
 All outcomes Unclear risk Insufficient information to permit judgement
Blinding of outcome assessment (detection bias) 
 All outcomes Unclear risk Insufficient information to permit judgement
Incomplete outcome data (attrition bias) 
 All outcomes High risk 9 out of 69 patients were excluded post‐operatively, prior to randomisation. One of these patients was withdrawn due to a post‐operative SCr rise (> 150 µmol/L)
Selective reporting (reporting bias) Low risk Study protocol matches outcomes presented
Other bias High risk A commercial funding source was used for this study