Clinical Efficacy of Spasmofen Suppository in the Emergency Treatment of Renal Colic A randomized, double blind, double dummy comparative trial

Background: Renal colic is typically characterized by the sudden onset of severe pain radiating from the flank to the groin and its acute management in emergency departments essentially aims at rapid pain relief. Spasmofen (Registered Trademark) is a brand of Amirya Pharmaceutical Company, Alexandria, Egypt. It is in the form of rectal suppositories containing ketoprofen 100 mg and hyoscine butylbromide 10 mg. This combination is intended for the rapid relief of severe colicky pain in renal system, hepatobiliary or gastrointestinal tract. This trial aims to compare a single-dose of Spasmofen suppository to a single IV ketorolac dose in patients with acute renal colic. Methods: A total of 80 eligible consecutive patients presenting to the emergency departments of 2 medical centers with acute renal colic were included in the study. Eligible patients who signed the informed consent were randomly assigned into 2 treatment groups. An experimental group (Spasmofen group) who received one Spasmofen rectal suppository plus an intravenous injection of 2 ml of normal saline solution and a control group (Ketorolac group) who received one ketorolac 30 mg/2ml ampoule IV plus one placebo suppository. Treatment success, defined as a change in the verbal rating score (VRS) from severe or moderate pain to none or mild at 60 minutes after the dose, was compared between groups using Chi-Square/Fisher Exact test. Percent reductions of visual pain analog scale (VPAS) scores at 15, and 60 minutes after the dose were compared between groups using Z test for proportions.