Abstract
BACKGROUND/AIM: Hyoscine-N-butylbromide (HBB) is an anticholinergic agent widely used to treat pain caused by spasms in the gastrointestinal and urogenital systems. The aim of this study was to compare the efficacy of HBB with a placebo in treating abdominal cramping pain caused by acute gastroenteritis in the emergency department (ED). MATERIALS AND METHODS: This was a prospective, double-blind, placebo-controlled, randomized trial conducted in a single-center academic ED from September to November 2021. Patients aged 18-65 years with acute gastroenteritis symptoms were included. The study compared the efficacy of intravenous HBB (20 mg) to a placebo. The primary outcome was the absolute change in pain score at 30 min after treatment, with secondary outcomes including pain relief at 60 min, adverse events, and the need for rescue analgesics. RESULTS: Fifty patients were randomized (25 in each group). There was no significant difference in 30-min and 60-min pain scores between the groups. At 60 min, pain reduction and the need for rescue analgesia were similar in both groups. Changes in pain scores from admission to 30 and 60 min did not significantly differ between the groups. CONCLUSION: Intravenous HBB did not show a statistically or clinically significant difference in pain reduction compared to a placebo in patients with acute gastroenteritis and cramping abdominal pain in the ED.