Oral diclofenac in the prophylactic treatment of recurrent renal colic. A double-blind comparison with placebo

Eur Urol. 1995;28(2):108-11. doi: 10.1159/000475031.


We have conducted a double-blind, randomized, placebo-controlled trial with oral diclofenac to study the prophylactic effect on renal colic recurrence and spontaneous stone expulsion rate. Forty-one patients were given 50 mg oral diclofenac 3 times a day for 7 days after being discharged for a colic episode from Oslo Emergency Hospital (< 24 h stay) and 39 patients were given matching placebo tablets. The number of new renal colic episodes per accumulated patient treatment days was 64/287 in the diclofenac group and 119/273 in the placebo group (p < 0.01). This difference was greatest during the first 4 treatment days. A similar trend was found for pain intensity (0-10 cm VAS) with the greatest difference on day 1 (4.3 vs. 2.8, p = 0.05). Side effects, mainly gastrointestinal, were reported for 14% of the treatment days in both treatment groups. Stone expulsion rate was almost identical (28 vs. 29 days), regardless of stone size. Readmission rate to Oslo Emergency Hospital/other hospitals were 10 and 67% (p < 0.001). In conclusion, oral treatment with diclofenac was effective as short-term prophylaxis of new colic episodes, especially during the first 4 days, and reduces the number of hospital readmissions significantly. The stone passage rate appears not to be affected.

Publication types

  • Clinical Trial
  • Comparative Study
  • Controlled Clinical Trial
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Administration, Oral
  • Adult
  • Analysis of Variance
  • Colic / drug therapy*
  • Cyclooxygenase Inhibitors / administration & dosage
  • Cyclooxygenase Inhibitors / therapeutic use*
  • Diclofenac / administration & dosage
  • Diclofenac / therapeutic use*
  • Double-Blind Method
  • Female
  • Humans
  • Indomethacin / administration & dosage
  • Indomethacin / therapeutic use
  • Kidney Calculi / drug therapy*
  • Male
  • Placebos
  • Recurrence


  • Cyclooxygenase Inhibitors
  • Placebos
  • Diclofenac
  • Indomethacin