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

Puolakka 2009.

Methods
  • Study design: parallel RCT

  • Study duration: not reported

  • Study follow‐up: 20 h post‐operatively

Participants
  • Country: Finland

  • Setting: single centre

  • Inclusion criteria: patients undergoing laparoscopic hysterectomy

  • Number: treatment group (15); control group (15)

  • Mean age ± SD (years): treatment group (48.5 ± 7.9); control group (50.5 ± 4.5)

  • Sex (M/F): All female

  • Exclusion criteria: allergy to aspirin‐like drugs or sulphonamide; bronchial asthma; liver or kidney disturbances; peptic ulcer; bleeding disorder; pregnancy; substance abuse; chronic pain

Interventions Treatment group
  • Parecoxib: single dose of 80 mg IV, before the induction of anaesthesia


Control group
  • Saline

Outcomes
  • SCr and sensitive urine and serum markers for renal tubular injury directly after induction of anaesthesia, 2 h after induction, first and second POD

Notes
  • Post hoc analysis shows that study is underpowered to detect statistically significant serious adverse events

  • Funding source: supported by the Medical Research Fund of Tampere University Hospital, Finland

Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Computer generated randomisation
Allocation concealment (selection bias) Low risk Random numbers in opaque envelopes
Blinding of participants and personnel (performance bias) 
 All outcomes Low risk Nurse not involved in the study made up the study drugs
Blinding of outcome assessment (detection bias) 
 All outcomes Unclear risk Insufficient information to permit judgement
Incomplete outcome data (attrition bias) 
 All outcomes Low risk No patients withdrawn. Missing data from 2 patients at variable time points. Missing outcome data balanced in numbers across intervention groups
Selective reporting (reporting bias) Low risk Study protocol matches outcomes presented
Other bias Low risk Non‐profit organisation funding received