PURPOSE: To compare the efficacy and adverse effects of oral diclofenac, topical eutectic mixture of local anesthesia (EMLA), and their combination for pain control during shockwave lithotripsy (SWL) and to investigate the need for supplemental analgesia, patient satisfaction, and overall treatment outcomes. PATIENTS AND METHODS: A series of 240 consecutive patients with urolithiasis scheduled for SWL between May 2006 and December 2006 were randomized equally into three groups that were treated as follows: group A oral (tablet) diclofenac sodium 60 minutes prior to SWL (50 mg for body weight <70 kg; 100 mg for body weight >70 kg); group B occlusive dressing of EMLA (5 g) 60 minutes prior to SWL; group C combination of oral diclofenac sodium (in the prescribed dose) and occlusive dressing of EMLA (5 g) 60 minutes prior to SWL. A visual analog scale (VAS) was used for the subjective evaluation of pain. The various parameters were recorded and analyzed statistically. RESULTS: The total number of shock waves delivered, the maximum voltage used, and SWL duration were statistically greater in group C (P < 0.0001). The VAS scores at 15, 30, 45, 60, and 120 minutes and the supplemental analgesia requirement were statistically less in group C (P < 0.0001). The stone fragmentation rate, stone-free rate at 3 months (88.75%), and modified Efficiency Quotient (0.64) were statistically greater in group C (P < 0.0001). The post-SWL auxiliary procedure rate (P < 0.0001) and Steinstrasse rate (P = 0.03) were statistically less in group C. CONCLUSIONS: The use of a combination of oral diclofenac sodium and an occlusive dressing of EMLA cream during SWL provides adequate analgesia with minimal morbidity, avoids the need for parenteral analgesics and their attendant side effects, and improves the success rate of SWL.
RCT Entities:
PURPOSE: To compare the efficacy and adverse effects of oral diclofenac, topical eutectic mixture of local anesthesia (EMLA), and their combination for pain control during shockwave lithotripsy (SWL) and to investigate the need for supplemental analgesia, patient satisfaction, and overall treatment outcomes. PATIENTS AND METHODS: A series of 240 consecutive patients with urolithiasis scheduled for SWL between May 2006 and December 2006 were randomized equally into three groups that were treated as follows: group A oral (tablet) diclofenac sodium 60 minutes prior to SWL (50 mg for body weight <70 kg; 100 mg for body weight >70 kg); group B occlusive dressing of EMLA (5 g) 60 minutes prior to SWL; group C combination of oral diclofenac sodium (in the prescribed dose) and occlusive dressing of EMLA (5 g) 60 minutes prior to SWL. A visual analog scale (VAS) was used for the subjective evaluation of pain. The various parameters were recorded and analyzed statistically. RESULTS: The total number of shock waves delivered, the maximum voltage used, and SWL duration were statistically greater in group C (P < 0.0001). The VAS scores at 15, 30, 45, 60, and 120 minutes and the supplemental analgesia requirement were statistically less in group C (P < 0.0001). The stone fragmentation rate, stone-free rate at 3 months (88.75%), and modified Efficiency Quotient (0.64) were statistically greater in group C (P < 0.0001). The post-SWL auxiliary procedure rate (P < 0.0001) and Steinstrasse rate (P = 0.03) were statistically less in group C. CONCLUSIONS: The use of a combination of oral diclofenac sodium and an occlusive dressing of EMLA cream during SWL provides adequate analgesia with minimal morbidity, avoids the need for parenteral analgesics and their attendant side effects, and improves the success rate of SWL.