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

Aitken 1992.

Methods
  • Study design: RCT

  • Study duration: not reported

  • Study follow‐up: 48 h

Participants
  • Country: UK

  • Setting: single centre

  • Inclusion criteria: undergoing elective upper abdominal surgery

  • Number: treatment group 1 (19); treatment group 2 (23); control group (21)

  • Mean age (years): treatment group 1 (47.2); treatment group 2 (48.6); control group (56.1)

  • Sex (M/F): treatment group 1 (19/10); treatment group 2 (10/13); control group (10/11)

  • Exclusion criteria: respiratory insufficiency hepatic or kidney impairment; abuse of alcohol or drugs

Interventions Treatment group 1
  • Ketorolac: 12.5 mg/h IM infusion for 30 min during surgery then 2.5 mg/h for 47.5 h, with normal saline injections every 4 h


Treatment group 2
  • Ketorolac: 10 mg every 4 h IM for 48 h, first dose during surgery


Control group
  • Intermittent and continuous infusions of saline to match other groups

Outcomes
  • Pre‐operative and post‐operative CrCl, urine output, sodium output, potassium output

Notes
  • Funding Source: Syntex research gave financial assistance and supplied the study drugs

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 Study described as "double‐blind"; 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 High risk 67 patients were randomised, of which 63 patients were included in the patient data table.
Six patients were withdrawn from the study after 24 or 48 h of treatment due to equipment failure or on patient's request. No data on randomisation of the withdrawn patients.
Of remaining 61 patients there is missing data from 15 patients, probably equally distributed amongst the intervention and placebo groups.
Selective reporting (reporting bias) Low risk Study protocol matches outcomes presented
Other bias High risk A commercial funding source was used for this study