Evidence-based safety profile of oral ketorolac in adults: Systematic review and meta-analysis

Abstract

The primary objective of the present review was to report the safety profile of oral ketorolac in adults using the systematic review and meta-analysis methodology based on clinical trials. The present study is a PRISMA-based systematic review and risk ratio (RR) meta-analysis of the adverse events reported in clinical trials that used oral ketorolac; the review includes 50 clinical trials. The RR for the comparison of a single intake of oral ketorolac versus placebo, including all types of adverse events, was RR = 2.59, IC95% (1.5102; 4.4360) with p = 0.02, the RR for the comparison of a multiple intakes of oral ketorolac versus placebo for all types of adverse events was RR = 1.39, IC95% (0.95; 2.05) with p = 0.093, the RR for the comparison of a single intake of oral ketorolac versus active drugs for all types of adverse events was RR = 0.61, IC95% (0.49; 0.77) with p < 0.0001, the RR for the comparison of multiple intakes of oral ketorolac versus active drugs for all types of adverse events was RR = 0.78, IC95%(0.65; 0.93) with p = 0.006. Multiple intakes of 5, 10, or 20 mg of oral ketorolac, in treatment over 1–10 days, do not increase the risk of adverse events compared to placebo and show a tendency to reduce the risk of adverse events compared to active drugs. When a single intake of ketorolac (5, 10, 20, or 30 mg) is compared to a placebo, the risk increases only for trivial and mild adverse events.