| Methods |
Double‐blind, randomised, placebo controlled trial.
Randomisation: by computer, stratified by type of surgery.
Sixty‐five patients withdrew from study. Reasons included adverse reactions (premature withdrawal from study due to nausea, vomiting, hypotension, decrease urine output, skin complaints, nervous system events), study administration problems, inadequate analgesia and intercurrent illness.
Intention to treat analysis done but no power calculation. |
| Participants |
207 patients undergoing major orthopaedic, gynaecological or general surgery.
Exclusions: know allergy, sensitivity or contraindications to any opioids, aspirin, or NSAIDs, history of active peptic ulcer within preceding 6 months, a history of bleeding problems or anticoagulant use within preceding 4 weeks, pregnancy or breast feeding, history of known or suspected alcohol or drug abuse, or a medical or psychiatric condition that would compromise ability to give informed consent. |
| Interventions |
Rx 1: 30 mg ketorolac IV bolus then 5 mg/h IV for 24 hours
Rx 2: 30 mg IV bolus then 15 mg IV every 3 hours for 24 hours
Pl: Placebo initial IV infusion bolus, IV infusion and IV bolus every 3 hours |
| Outcomes |
Urine output |
| Notes |
Oliguria was not defined. No significant difference in the incidence of oliguria between the three groups. |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Allocation concealment (selection bias) |
Low risk |
A ‐ Adequate |
