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

Khalil 2006a.

Methods
  • Study design: RCT

  • Study duration: 2 years

  • Study follow‐up: 48 hours

Participants
  • Country: UK

  • Setting: single centre

  • Inclusion criteria: elective coronary artery bypass grafting

  • Number: treatment group (21); control group (19)

  • Mean age ± SD (years): treatment group (56.7 ± 9.1); control group (58.8 ± 6.6)

  • Sex (M/F): not reported

  • Exclusion criteria: diabetics; on anticoagulants; previous cerebrovascular disease

Interventions Treatment group
  • Parecoxib: single IV dose of 40 mg given at closure of sternotomy


Control group
  • Placebo: single IV dose given at closure of sternotomy

Outcomes
  • 24 hour urinary CrCl, urinary a‐1‐microglobulin

Notes
  • Funding: Pharmacia

  • Furosemide given in post‐operative phase for oliguria; (treatment 12/21 patients, control 9/19 patients)

Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Computerised randomisation using a number generator
Allocation concealment (selection bias) Low risk A third party placed the results of the randomisation in sealed envelopes
Blinding of participants and personnel (performance bias) 
 All outcomes Low risk Envelopes were opened at close of the surgery and a third party prepared the study medication (placebo or treatment) which looked identical
Blinding of outcome assessment (detection bias) 
 All outcomes Unclear risk Insufficient information to permit judgement
Incomplete outcome data (attrition bias) 
 All outcomes Low risk Initial power calculations resulted in an intended study population size of 60 patients. Following a global announcement of Pfizer that parecoxib was ‘contraindicated in patients with ischaemic heart disease’ further inclusion in the study was terminated at 40. Data of all 40 patients is presented
Selective reporting (reporting bias) Low risk Study protocol matches outcomes presented
Other bias High risk Commercial funding source Pharmacia, which is the manufacturer of Parecoxib