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

Varrassi 1994.

Methods
  • Study design: parallel RCT

  • Study duration: not reported

  • Study follow‐up: 24 h post‐operatively

Participants
  • Country: Italy

  • Setting: single centre

  • Inclusion criteria: patients undergoing elective cholecystectomy

  • Number: treatment group (48); control group (47)

  • Mean age ± SE (years): treatment group (52.5 ± 1.4); control group (50.2 ± 1.6)

  • Sex (M/F): treatment group (17/31); control group (15/32)

  • Exclusion criteria: pregnancy; history of peptic ulceration; coagulopathies; impaired kidney function; allergy or intolerance to NSAIDs; alcohol or opioid abuse; children; > 65 years

Interventions Treatment group
  • Ketorolac: 30 mg IM before surgery then 2 mg/h IV infusion for 24 h


Control group
  • Normal saline: 1 mL IM then 2 mL/h IV infusion for 24 h

Outcomes
  • Post‐operative SCr

Notes
  • Funding Source: supported in part by CNR Grants

  • SCr level taken in recovery (and after first IM injection of ketorolac/placebo) is used as baseline SCr level. No pre‐operative SCr reported

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 All outcomes Low risk 5 out of 100 patients were withdrawn from the study after randomisation and administration of the study drug. 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 Unclear risk Insufficient information to permit judgement

AKI ‐ acute kidney injury; ASA ‐ American Society of Anesthesiologists; CrCl ‐ creatinine clearance; DM ‐ diabetes mellitus; eGFR ‐ estimated glomerular filtration rate; ESKD ‐ end‐stage kidney disease; GI ‐ gastrointestinal; ICU ‐ intensive care unit; IM ‐ intramuscular; IV ‐ intravenous; MI ‐ myocardial infarction; NSAIDs ‐ nonsteroidal anti‐inflammatory drugs; POD ‐ post‐operative day/s; RRT ‐ renal replacement therapy; SCr ‐ serum creatinine