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

Koppert 2006.

Methods
  • Study design: parallel RCT

  • Study duration: 2002 to 2003

  • Study follow‐up: 3 POD

Participants
  • Country: Germany

  • Setting: single centre

  • Inclusion criteria: elderly patients ≥ 85 years undergoing hip replacement or surgery of the femoral shaft

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

  • Mean age ± SD (years): treatment group 1 (76.0 ± 8.0); treatment group 2 (76.7 ± 8.9); control group (76.7 ± 8.6)

  • Sex (M/F): treatment group 1 (9/16); treatment group 2 (14/11); control group (11/14)

  • Exclusion criteria: angina or congestive heart failure; recent history of MI, coronary angioplasty, coronary arterial bypass, stroke or transient ischaemic attack; uncontrolled hypertension or uncontrolled DM; kidney disease; bleeding disorders; any disease that the investigator believed would pose a risk to the patient

Interventions Treatment group 1
  • Parecoxib: 40 mg and 12 hourly subsequently


Treatment group 2
  • IV paracetamol: infusion of 1000 mg and 6 hourly subsequently


Control group
  • IV saline: over 10 min

Outcomes
  • Differences in CrCl pre‐operatively and up to 6 h post‐operatively

Notes
  • Funding source: unknown quantity of support provided by Bristol‐Myers Squibb

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 All study medication solutions were prepared by a hospital pharmacist who was not involved in the data collection
Blinding of participants and personnel (performance bias) 
 All outcomes Low risk The anaesthesiologist, nursing staff, and the investigators were all blinded to the treatment. At the surgical ward, patients and nursing staff were unblinded to the medication.
Blinding of outcome assessment (detection bias) 
 All outcomes Unclear risk Insufficient information to permit judgement
Incomplete outcome data (attrition bias) 
 All outcomes Low risk Eight of 83 patients withdrew from study. 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 High risk A commercial funding source was used for this study