Introduction and Objectives
This prospective, randomized and double-blind clinical study aimed to assess the analgesic efficacy of single dose intramuscular (i.m.) injection of dexketoprofen (Group DE) compared with single dose i.m. injection of diclofenac (Group DI) in patients undergoing shockwave lithotripsy (SWL) procedure.
Material and Methods
A total of 70 males with single renal or ureteric stones were randomly separated into two groups. The 40 males in Group DI received 75 mg i.m. diclofenac sodium and 30 males in Group DE received 50 mg i.m. 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 two groups (p > 0.05). 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 males in Group DI, the SWL procedure was performed with no, minor or tolerable pain. But, in Group DE, 28 (93.3%) out of 30 cases evaluated the pain severity as no, minor or tolerable (p = 0.01). No major/ minor adverse effects were observed in Group DI, whereas in 1 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 a SWL procedure, 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.
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Copyright
© 2009 European Association of Urology. Published by Elsevier Inc. All rights reserved.