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Background and Purpose: This prospective, randomized, and double-blind clinical study aimed to assess the analgesic efficacy of single-dose intramuscular (IM) injection of dexketoprofen (group DE) compared with single-dose IM injection of diclofenac (group DI) in patients who were undergoing shockwave lithotripsy (SWL). Patients and Methods: A total of 70 men with single renal or ureteral stones were randomly separated into two groups. The 40 men in group DI received 75mg IM diclofenac sodium and 30 men in Group DE received 50mg IM dexketoprofen trometamol 30 minutes before SWL. A 10-point visual analog scale was used to evaluate pain. Results: The age, body mass index, and mean stone burden were comparable between the two groups (P>0.05). The mean visual analog scale score for group DE was statistically lower compared with the score for group DI (P=0.02). In 34 (85%) of the 40 men in group DI, the SWL procedure was performed with no, minor, or tolerable pain. In group DE, however, 28 (93.3%) of 30 patients evaluated the pain severity as no, minor, or tolerable (p=0.01). No major/minor adverse effects were observed in group DI, whereas in one patient in group DE, dyspepsia after injection was noticed (P=0.423). Conclusions: The severity of SWL-related pain was significantly better tolerated with dexketoprofen trometamol. During an SWL procedure, the analgesic efficacy of dexketoprofen was greater than that of diclofenac sodium. Although statistically insignificant, a little increased risk for gastric irritation was noticed with dexketoprofen. © Mary Ann Liebert, Inc. 2010.