Diclofenac sodium in biliary colic: a double blind trial.

We studied 30 consecutive outpatients (14 men and 16 women; mean (SD) age 46 (11-8) years) with gallstone disease, confirmed by ultrasonography or radiography or at operation, who complained of biliary colic. Patients were randomly treated under double blind conditions with either 75 mg diclofenac sodium given intramuscularly or placebo and were followed up for 24 hours. All patients had given their informed consent. Before the injection and 25 minutes afterwards patients estimated the intensity of their pain on a 100 mm analogue chromatic continuous scale on which 0 mm represented no pain and 100 mm represented unbearable pain.5 Every five minutes after the injection relief of pain was also assessed on a three point scale (1= no relief, 2= partial relief, 3= complete relief). Patients whose pain was not relieved 25 minutes after the injection and who asked for an analgesic were treated with 75 mg diclofenac sodium intramuscularly, and relief of pain was registered using the three point scale 30 minutes later. Fourteen patients were given diclofenac and 16 placebo. The two groups were similar for age, weight, sex, duration of pain, and initial intensity of pain according to the analogue scale. The median duration of pain before injection was three hours in the patients given diclofenac and four hours in those given placebo. The table shows that partial or complete relief of pain was achieved 15 minutes after the injection in all patients given diclofenac and in two (12-5%) of the 16 given placebo (X2 test, p<00001). Complete relief of pain was achieved 25 minutes after the injection in nine (64%) of the patients given diclofenac and none of those given placebo (p < 0 01). Mean (SD) intensity of pain changed from 80-2 (13-07) mm on the analogue scale to 9-7 (8.78) mm 25 minutes after injection in the group given diclofenac (paired t test, p< 0-001) and from 85-7 (9 53) to 86-0 (9 87) mm in the group given placebo (NS). There was a significantly greater reduction of pain in the group given diclofenac compared with placebo (trend analysis, F= 85-48, p < 0001). During the 24 hour follow up period none of the patients given diclofenac but all of those given placebo needed an injection of 75 mg diclofenac after 25 minutes due to persistent and severe pain. Of the 16 patients treated with diclofenac, nine had partial and seven complete relief of pain within 30 minutes. No side effects were experienced.