RESUMEN
STUDY OBJECTIVE: To compare analgesic efficacy and safety of intravenous lidocaine and ketorolac combination to each analgesic alone for ED patients with suspected renal colic. METHODS: We conducted a randomized, double-blind trial comparing analgesic efficacy of a combination of intravenous lidocaine (1.5â¯mg/kg) and ketorolac (30â¯mg), to ketorolac (30â¯mg), and to lidocaine (1.5â¯mg/kg) in patients aged 18-64 presenting to the ED with suspected renal colic. Primary outcome included difference in pain scores between the groups at 30â¯min. Secondary outcomes included a comparative reduction in pain scores in each group from baseline to 30 and 60â¯min as well as rates of adverse events and need for rescue analgesia at 30 and 60â¯min. RESULTS: We enrolled 150 subjects (50 per group). The difference in mean pain scores at 30â¯min between Lidocaine and Lidocaine/Ketorolac groups was -2.89 (95% CI: -4.39 to -1.39); between Ketorolac and Lidocaine/Ketorolac group was -0.92 (95% CI: -2.44 to 0.61); and between Ketorolac and Lidocaine was -1.98 (95% CI: -3.69 to -0.27). A comparative percentage of subjects in each group required rescue analgesia at 30 and 60â¯min. No clinically concerning changes in vital signs were observed. No serious adverse events occurred in either group. Commonly reported adverse effects were dizziness, nausea, and headache. CONCLUSION: The administration of intravenous lidocaine/ketorolac combination to ED patients with suspected renal colic results in better analgesia in comparison to lidocaine alone but provides no analgesic advantages over ketorolac alone. Clinicaltrials.gov Registration: NCT02902770.