Clinical efficacy of Spasmofen® suppository in the emergency treatment of renal
colic: a randomized, double-blind, double-dummy comparative trial.
Author(s): Yakoot M(1), Salem A(2), Yousef S(2), Helmy S(3).
Affiliation(s): Author information:
(1)Green Clinic and Research Center, Alexandria, Egypt. (2)Alexandria Helmy
Medical Center, Alexandria, Egypt. (3)Pharco Corporation, Alexandria, Egypt.
Publication date & source: 2014, Drug Des Devel Ther. , 8:405-10
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(®) is a brand of
Amriya Pharmaceutical Industries 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 the renal system, hepatobiliary
system, or gastrointestinal tract. This trial aims to compare a single-dose of
Spasmofen rectal suppository to a single intravenous (IV) ketorolac tromethamine
30 mg/2 mL dose in patients with acute renal colic.
METHODS: A total of 80 eligible consecutive patients presenting to the emergency
departments of two medical centers with acute renal colic were included in the
study. Eligible patients who signed the informed consent were randomly assigned
into two treatment groups: an experimental group (Spasmofen group) who received
one Spasmofen rectal suppository plus an IV injection of 2 mL of normal saline
solution; and a control group (ketorolac group) who received one ketorolac 30
mg/2 mL ampoule IV plus one placebo suppository. Treatment success, defined as a
change in the verbal rating score from severe or moderate pain to none or mild at
60 minutes after the dose, was compared between groups using the
chi-square/Fisher's exact test. Percentage reductions in visual pain analog scale
(VPAS) scores at 15 and 60 minutes after the dose were compared between groups
using the Z-test for proportions.
RESULTS: Successful treatment at 60 minutes occurred in 35 of 40 (87.5%) of
Spasmofen-treated patients and in 33 of 40 (82.5%) of ketorolac-treated patients.
The difference was not statistically significant by Fisher's exact test
(P=0.755). The mean percentage reduction of VPAS after 15 minutes was 61.82% in
the Spasmofen-treated group and 64.76% in the ketorolac-treated group. The
difference was also not statistically significant by the Z-test for proportions
(P=0.795). Sixty minutes after being treated, Spasmofen was associated with a
statistically significant greater reduction in VPAS (mean% reduction =92.36%)
than ketorolac (75.06%; P=0.0466).
CONCLUSION: Single-dose Spasmofen rectal suppository might be a safe and
effective first-aid treatment for the emergency department relief of acute renal
colic.
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