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. Comparative study of the efficacy of dipyrone, diclofenac sodium and pethidine in acute renal colic. Collaborative Group of the Spanish Society of Clinical Pharmacology. Diclofenac versus dipyrone in acute renal colic: a double-blind controlled trial. Nifedipine in the treatment of renal colic. Intramuscular diclofenac sodium versus intravenous Baralgin in the treatment of renal colic. [A double-blind study of the analgesic efficacy in kidney colic of the combination of dipyrone and spasmolytic with ketorolac trometamol]. Double-blind study with dipyrone versus tramadol and butylscopolamine in acute renal colic pain. [Flubiprofen vs dipyrone combined with hyoscine: the analgesic efficacy in 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 were compared in 293 patients (aged 18-70 years) with acute renal colic. A level of > or = 50 mm on the 100-mm visual analogue scale was required for inclusion in the study. Patients were randomly allocated to six treatment groups, receiving dipyrone 1 g i.m., dipyrone 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. Evaluations were performed at 10, 20, 30, and 60 min and 2, 4, and 6 h after treatment (time 0). Primary efficacy end points included course of pain, total pain, percentage of patients with a pain improvement of 50% or more at each evaluation time, pain intensity evaluated by the investigator on a 0-3 scale, and differences in pain intensity. The analgesic response was more marked and prolonged among patients receiving dipyrone 2 g i.m. or dipyrone 2 g i.v. There were no significant differences between dipyrone 1 g and diclofenac sodium 75 mg, by either the i.m. or the i.v. route. All treatment regimens were well tolerated. A randomized, double-blind, multicentre clinical trial was designed to compared the analgesic efficacy of i.m. dipyrone 1 and 2 g, i.m. diclofenac sodium and i.m. pethidine in acute renal colic. The study was carried out in 451 patients in 13 Spanish hospitals. Ureteric colic was diagnosed by the clinical features, urinalysis, or when the presence of a ureteric calculus was confirmed. The severity of pain was assessed by the physicians and by patients using visual analogue scales. The main parameter of drug efficacy was the need for rescue treatment-pethidine 100 mg i.m. 30 min after the experimental treatment. Rescue treatment was required in 93 patients: they represented 24.1% of the group given dipyrone 1 g; 22.3% of those on dipyrone 2 g; 16.4% of those given diclofenac sodium; and 19.5% of those on pethidine. The differences between the groups were not significant. In the remaining 358 patients, no difference between treatments was observed. The results suggest that in acute renal colic the use of dipyrone 2 g is unjustified as dipyrone 1 g is equally effective. Diclofenac sodium is a valid alternative, which shows similar analgesic efficacy. A randomized, double-blind clinical trial in 50 patients was done to compare the efficacy and tolerance of single doses of intramuscular diclofenac 75 mg and dipyrone 2 g in acute renal colic. Both drugs were equally effective, but diclofenac was better in terms of complete relief of pain. Vital signs were affected according to the stress and pain. A double-blind randomized, clinical trial was conducted in 43 patients to evaluate the efficacy of sublingual nifedipine in the treatment of pain in renal colic. Comparison was made with a combination of dipyrone, pitofenone and fenpipramide, which is usually administered intravenously in Spain. With nifedipine, pain completely disappeared in 44% of the cases, and with the combination of drugs, in 89% (p less than 0.005). More adverse effects were noted with the combination than with nifedipine. Both treatments brought about a slight drop in arterial pressure without leading to hypotension in any case. There was no change in heart rate. The possible causes of the relatively low level of success with nifedipine were analyzed. The possibility of using nifedipine under certain circumstances in which other drugs are contraindicated or when their administration is unfeasible is suggested. A comparative, randomized, double-blind study of diclofenac sodium 75 mg im versus Baralgin (a combination drug composed of dipyrone and two spasmolytics) 5 mL iv was performed on 57 patients with renal colic. Both groups were comparable as to age, sex, pain evolution time before treatment, and no treatment for renal colic in the six hours preceding trial drug administration. No significant differences were found between the two groups with respect to the evolution of pain after the first dose or in the frequency of administration of a second dose. Tolerability was good in both groups, but sweating and pain throughout the vein were observed in one patient in the Baralgin group. We concluded that diclofenac sodium constitutes an excellent alternative to pyrazolone analgesics, with the advantages of being monotherapy and having good tolerability, when used as intramuscular injection in ambulatory patients. We conducted a double-blind study in 34 patients to compare the analgesic efficacy in acute renal colic using 2.5 g dipyrone combined with a spasmolytic agent and 30 mg ketorolac tromethamine, diluted in 100 ml saline solution and injected intravenously. Clinical criteria and the observation of red cells in urine were used for the diagnosis. The intensity of the pain and its development were measured using visual analogue scales (VAS) and a scale of items showing patient improvement. The side effects were spontaneously mentioned by the patients and elicited by direct questioning. It can be confirmed with a beta error of 0.10 that the analgesic effect obtained by both treatments is similar. Nevertheless, the combination of dipyrone and spasmolytic produces more side effects, possibly due to the spasmolytic agent. To investigate the combined analgesic and spasmolytic effect of dipyrone, 104 patients suffering from "severe" or "excruciating" colic pain due to a confirmed calculus in the upper urinary tract were randomized to receive i.v. either 2.5 g dipyrone (36 patients), 100 mg tramadol (35 patients), or 20 mg butylscopolamine (33 patients) in a multicentre, observer-blind, parallel-group study conducted in 8 German centres. 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 administration, and was significantly more effective than butylscopolamine at 30 and 50 min for the secondary efficacy endpoint, pain intensity differences on a categorical scale. Dipyrone had the highest SPID0-2 h of the three drugs (P < 0.05). Only 5 patients receiving dipyrone needed "rescue" medication as compared with 13 patients given tramadol and 11 patients receiving butylscopolamine. Adverse events were observed in 4 patients receiving butylscopolamine and in 1 patient each given dipyrone and tramadol. "Distinct" pain relief as assessed on a visual analogue scale (VAS) is a reliable method of determining the onset of analgesic action in the colic pain model. We compared the efficacy of flurbiprofen (NSAID) versus dipirone + hyoscine N-butylbromide in the treatment of nephric colic.
                The study comprised 135 patients, aged 18 to 75 yrs, with intense nephric colic. The patients were observed 60 min after a single IM dose of 150 mg flurbiprofen (n = 67) or 2 gm dipirone + 20 mg hyoscine N-butylbromide.
                Both treatment modalities were well-tolerated and afforded significant pain relief. Flurbiprofen, however, was faster-acting and superior to dipirone + hyoscine in the overall evaluation of good and excellent therapeutic response rates.
                The results of the study show that IM flurbiprofen is a useful alternative to dipirone + hyoscine N-butylbromide in the treatment of nephric colic.
Limited available data indicated that single dose dipyrone was of similar efficacy to other analgesics used in renal colic pain, although intramuscular dipyrone was less effective than diclofenac 75 mg. Combining dipyrone with antispasmolytic agents did not appear to improve its efficacy. Intravenous dipyrone was more effective than intramuscular dipyrone. Dry mouth and somnolence were commonly reported with intravenous dipyrone. None of the studies reported agranulocytosis.