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

Rafiq 2014.

Methods
  • Study design: parallel RCT

  • Study duration: March 2007 to August 2009

  • Study follow‐up: 30 POD

Participants
  • Country: Denmark

  • Setting: single centre

  • Inclusion criteria: patients requiring cardiac surgery (medial sternotomy)

  • Number: treatment group (77); control group (74)

  • Mean age ± SD (years): treatment group (62 ± 12); control group (64 ± 13)

  • Sex (M/F): treatment group (61/16); control group (59/15)

  • Exclusion criteria; peripheral neuropathy; neurological disease; psychiatric illness; history of GI bleeding; chronic pain; SCr >150 µmol/L, hepatic disease with elevated liver enzymes; allergic to study medication; alcohol abuse; abuse of narcotics or medication; pregnancy; participation in other clinical trials; insufficient language skills; ICU stay > 24 h

Interventions Treatment group
  • Ketorolac: 30 mg IV during extubation, followed by ibuprofen 400 mg 4 times/d


Control group
  • Morphine: 10 mg 4 times/d.

Outcomes
  • Maximum post‐operative SCr and individual rise in SCr

  • Length of hospital stay, death and need for RRT post‐operatively

Notes
  • Funding source: no funding received

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 Sequentially numbered, opaque sealed envelope
Blinding of participants and personnel (performance bias) 
 All outcomes High risk Open‐label study
Blinding of outcome assessment (detection bias) 
 All outcomes High risk Open‐label study
Incomplete outcome data (attrition bias) 
 All outcomes Low risk Of 180 randomised patients, 29 patients were withdrawn prior to administration of the study drug. Missing outcome data balanced in numbers across intervention group with similar reasons for missing data across groups
Selective reporting (reporting bias) Low risk Maximum SCr reported
Other bias Low risk The study appears to be free of other sources of bias