COMPARISON OF THE ONSET AND DURATION OF THE ANALGESIC EFFECT OF DIPYRONE, 1 OR 2 G, BY THE INTRAMUSCULAR OR INTRAVENOUS ROUTE, IN ACUTE RENAL COLIC

In a double-blind, double-dummy randomized controlled clinical trial, the onset and duration of the analgesic effect of dipyrone, 1 or 2 g, and diclofenac sodium, 75 mg, by either the i.m. or the i.v. route wer e compared in 293 patients (aged 18-70 years) with acute renal colic. A level of greater than or equal to 50 mm on the 100-mm visual analogu e scale was required for inclusion in the study. Patients were randoml y allocated to six treatment groups, receiving dipyrone 1 g i.m., dipy rone 1 g i.v., dipyrone 2 g i.m., dipyrone 2 g i.v., diclofenac sodium 75 mg i.m.; and diclofenac sodium 75 mg i.v, respectively. Evaluation s were performed at 10, 20, 30, and 60 min and 2, 4, and 6h after trea tment (time 0). Primary efficacy end points included course of pain, t otal pain, percentage of patients with a pain improvement of 50% or mo re at each evaluation time, pain intensity evaluated by the investigat or on a 0-3 scale, and differences in pain intensity. The analgesic re sponse was more marked and prolonged among patients receiving dipyrone 2 g i.m. or dipyrone 2 g i.v. There were no significant differences b etween dipyrone Ig and diclofenac sodium 75 mg, by either the i.m. or the i.v. route. All treatment regimens were well tolerated.