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

Jones 2000.

Methods
  • Study design: parallel RCT

  • Study duration: not reported

  • Study follow‐up: 96 h post‐operatively

Participants
  • Country: Australia

  • Setting: single centre

  • Inclusion criteria: women aged 50 to 70 years undergoing major gynaecological surgery (ovarian, uterine or cervical cancer)

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

  • Mean age ± SD (years): treatment group (60.3 ± 6.3); control group (60.3 ± 6.9)

  • Sex (M/F): All female

  • Exclusion criteria: kidney or hepatic impairment; bleeding diathesis; hypersensitivity to NSAIDs; asthma; medications known to interfere with tenoxicam disposition

Interventions Treatment group
  • Tenoxicam: 20 mg IV given 2 h before surgery


Control group
  • Normal saline: IV given 2 h before surgery

Outcomes
  • Pre‐operative and post‐operative (at 2, 24, 48, 72, and 96 h) measurements of CrCl, SCr, fractional excretion of sodium and potassium

Notes
  • Funding source: unknown quantity of support provided by Hoffmann‐La Roche & Co, Basle, Switzerland

Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Roche pharmaceuticals coded and allocated 30 patients using random number tables
Allocation concealment (selection bias) Low risk Study drugs made up by Roche pharmaceuticals
Blinding of participants and personnel (performance bias) 
 All outcomes Low risk The allocation was not released until the end of clinical data collection
Blinding of outcome assessment (detection bias) 
 All outcomes Low risk The allocation was not released until the end of clinical data collection
Incomplete outcome data (attrition bias) 
 All outcomes Low risk No incomplete data
Selective reporting (reporting bias) Low risk Study protocol matches outcomes presented
Other bias High risk A commercial funding source was used for this study