Clinical Efficacy of Intravenous Papaverine plus Ketorolac in the Emergency Treatment of Renal Colic: A Randomized, Double-blind Clinical Trial.

Abstract

Background: Acute renal colic has been challenging and has brought many concerns for physicians and patients for centuries. This study aimed to evaluate the analgesic effect and safety of a combination of papaverine and ketorolac against ketorolac and placebo in treating acute renal colic.

Methods: This randomized clinical trial was performed in patients with renal colic from May 2018 to May 2020 in Ahvaz, Iran. Patients with colic pain due to sand or kidney stones underwent clinical examination. The pain intensified based on the visual analog scale (VAS) and the patients' need for rescue analgesia are considered as primary outcomes at various times after treatment. Patients were equally divided into two groups: A (ketorolac plus papaverine) and B (ketorolac plus placebo) by block balanced randomization method. Student t test, the Chi square, and ANOVA tests were used for statistical analyses, which were performed by SPSS 19.0. P<0.05 was considered significant.

Results: A significant difference was observed in 280 patients (140 patients in each group) in pain intensity between both groups at 45 and 60 min. VAS scores in groups A and B were 5.08±1.23 and 5.56±1.11 in 45 min and 3.35±1.47 and 3.92±1.31 in 60 min (P=0.001, P=0.002), respectively. In subgroup analysis, the VAS score significantly decreased after taking the drug for middle and proximal ureteral stones at 45 and 60 min (P<0.001). Rescue analgesics were required in 7 (5%) and 21 (15%) patients in groups A and B, respectively (P=0.005). Side effects were similar in the two groups.

Conclusion: In this study, ketorolac, along with papaverine, was effective in acute renal colic control, and combination therapy with ketorolac and papaverine was associated with reduced use of other rescue analgesics.Trial Registration Number: IRCT20190217042738N1.