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

Eljezi 2017.

Methods
  • Study design: parallel RCT

  • Study duration: not reported

  • Study follow‐up: 48 h

Participants
  • Country: France

  • Setting: inpatient

  • Inclusion criteria: patients undergoing elective open heart surgery or coronary artery bypass grafting

  • Number: treatment group 1 (25); treatment group 2 (25); treatment group 3 (24) control group (23)

  • Mean age ± SD (years): treatment group 1 (63 ± 9); treatment group 2 (63. ± 7); treatment group 3 (60 ± 11); control group (58 ± 13)

  • Sex (M/F): treatment group 1 (23/2); treatment group 2 (22/3); treatment group 3 (24/0) control group (12/11)

  • Exclusion criteria: kidney insufficiency defined as a CrCl < 60 mL/min‐1; hepatic insufficiency; congestive heart failure with ejection fraction < 45%; history of gastric peptic ulcer or GI bleeding; DM needing insulin therapy; preoperative coagulation disorder; allergy to NSAID; pregnancy or breastfeeding

Interventions Treatment group 1
  • IV ketoprofen: 0.5 mg/kg every 6 h for 48 h


Treatment group 2
  • IV ketoprofen 0.25 mg/kg every 6 h for 48 h


Treatment group 3
  • IV ketoprofen: 0.125 mg/kg every 6 h for 48 h


Control group
  • IV normal saline

Outcomes
  • Pre‐operative SCr then SCr level at POD 1 and POD 2

  • Urine output every 4 h until 48 h post‐operatively

Notes
  • Only 48 h SCr and urine output results documented

  • 100 patients randomised, 97 patient analysed

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 Allocation was concealed in an envelope
Blinding of participants and personnel (performance bias) 
 All outcomes Low risk The study drug was prepared by an anaesthetist nurse not involved of post‐operative care, under the control of the anaesthetist in charge of the patient, who opened the allocation envelope
Blinding of outcome assessment (detection bias) 
 All outcomes Unclear risk Insufficient information to permit judgement
Incomplete outcome data (attrition bias) 
 All outcomes Low risk There is no incomplete data
Selective reporting (reporting bias) High risk Methods state 4 hourly urinary output measurements until 48 h post‐operatively and SCr measurement for POD 1 and POD 2. No urinary output results documented for 0 – 44 h. SCr documented at baseline and a percentage rise at 48 h reported. No results for POD 1 reported
Other bias Low risk The study was conducted by the Department of Anesthesiology (Medecine Peri‐Operatoire) and the Clinical Pharmacology centre (CPC‐CIC) of the University Hospital of Clermont‐Ferrand (CHU Clermont‐Ferrand), France. The sponsorship was limited to supplies and expenses. The sponsorship included payment for employees for study design, patient’s inclusion, data entry, and analysis of the data. They also provided the study drugs at no cost. They had no influence or interference after the protocol was designed