DOUBLE-BLIND-STUDY WITH DIPYRONE VERSUS TRAMADOL AND BUTYLSCOPOLAMINEIN ACUTE RENAL COLIC PAIN

To investigate the combined analgesic and spasmolytic effect of dipyro ne, 104 patients suffering from ''severe'' or ''excruciating'' colic p ain due to a confirmed calculus in the upper urinary tract were random ized to receive i.v. either 2.5 g dipyrone (36 patients), 100 mg trama dol (35 patients), or 20 mg butylscopolamine (33 patients) in a multic entre, observer-blind, parallel-group study conducted in 8 German cent res. The three treatment groups were homogeneous when analyzed by age, sex, height, and baseline pain intensity. Dipyrone was significantly more effective than tramadol in reducing pain for the primary endpoint , pain intensity differences (PID) at 20, 30, and 50 min after drug ad ministration, and was significantly more effective than butylscopolami ne at 30 and 50 min for the secondary efficacy endpoint, pain intensit y differences on a categorical scale. Dipyrone had the highest SPIDO-2 h Of the three drugs (P < 0.05). Only 5 patients receiving dipyrone n eeded ''rescue'' medication as compared with 13 patients given tramado l and 11 patients receiving butylscopolamine. Adverse events were obse rved in 4 patients receiving butylscopolamine and in 1 patient each gi ven dipyrone and tramadol. ''Distinct'' pain relief as assessed on a v isual analogue scale (VAS) is a reliable method of determining the ons et of analgesic action in the colic pain model.