None listed
Conditions
Brief summary
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.
Interventions
One Spasmofen (Registered Trademark) rectal suppository containing ketoprofen 100 mg and hyoscine butylbromide 10 mg, a brand of Amirya Pharmaceutical Company, Alexandria, Egypt.
Plus 2 mls of Normal saline solution intravenous (IV)
Sponsors
Mostafa Yakoot
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
typical moderate to severe unilateral abdominal or flank pain that the treating emergency physician clinically diagnosed it as renal colic with or without a positive imaging picture suggestive of renal calculi
Exclusion criteria
pregnancy or breast-feeding; patient size or weight far from the average for adult dose; history of allergy to an anticholinergic or any NSAID; and history of peptic ulcer disease, gastrointestinal bleeding, perforation, or inflammatory bowel disease
Outcome results
None listed