Abstract
Introduction: Background: Renal colic is a frequent urological emergency marked by severe, sometimes incapacitating pain as a ureteral stone passes. Timely analgesia is central to emergency management; effective options are needed. Non-steroidal anti-inflammatory drugs (NSAIDs) such as ketorolac are commonly used as first-line treatment; however, they are contraindicated in some patients and do not provide adequate analgesia for all. Intravenous lidocaine, a sodium channel blocker, has shown analgesic effects in several acute pain models. Intravenous magnesium sulfate, an N-methyl-D-aspartate (NMDA) receptor antagonist, may also influence central pain sensitization.
Methods: This study is designed as a prospective, randomized, double-blind, active-controlled, parallel-group clinical trial. Eligible participants will be randomly assigned to one of three groups: (1) IV lidocaine, (2) IV magnesium sulfate, or (3) IV ketorolac. Pain severity will be assessed using a Visual Analog Scale (VAS) at 5, 10, 15, and 30 minutes after injection. Patient data will be entered into SPSS and analyzed using a paired t-test to obtain the final results.
Results: This trial protocol compares the analgesic efficacy, safety profiles, and urinary outcomes of intravenous lidocaine, magnesium sulfate, and ketorolac for acute renal colic management in the emergency department. The findings aim to establish whether alternative non-opioid regimens offer superior or comparable pain reduction and opioid-sparing benefits compared to standard care.
Conclusion: This protocol describes a structured approach intended to generate high-quality evidence by directly comparing three intravenous analgesic strategies for renal colic.
Trial Registration: Clinical trial ID IRCT20090923002496N13. Registration date: 21 October 2023. https://irct.behdasht.gov.ir/trial/73232.