Analgesic Efficacy of Intravenous Hyoscine-N-Butylbromide (HNB) in Abdominal Colic Associated With Acute Gastroenteritis

Phase 4

• Conditions: Abdominal Cramps
• Interventions: Drug: Hyoscine-N-Butylbromide

• Registration Number: NCT02508142
• Lead Sponsor: Kocaeli University

Brief Summary

This study aims to assess the analgesic efficacy and safety of intravenous 20 mg Hyoscine-N-Butylbromide versus placebo for the treatment of abdominal colic associated with acute gastroenteritis in the emergency department.

Detailed Description

Acute gastroenteritis is a frequent cause of emergency department (ED) presentation. Mainstays of ED treatment are rehydration and antiemetics when needed. Since crampy abdominal pain accompanies (diarrhea) acute gastroenteritis in 67-90% of patients, emergency physicians may have to deal with spasmodic colics in these patients.

Hyoscine-N-butylbromide (HNB), is an anticholinergic agent which has been in use as an antispasmodic agent for sixty years all over the world. It has been studied and revealed various efficacy for several conditions (e.g; biliary colic, renal colic, endoscopic interventions, radiologic interventions, during labor, nonspecific abdominal pain and irritable bowel syndrome).

HNB is commonly used for symptomatic relief of abdominal cramps associated with acute gastroenteritis in the EDs, whereas the literature lacks evidence regarding its efficacy and safety for this condition.

The aim of this study is to assess the analgesic efficacy and safety of intravenous 20 mg hyoscine-n-butylbromide versus placebo in patients with abdominal colic associated with acute gastroenteritis in the emergency department.

Study Timeline

• Status Verified: 2015-07
• Study Start: 2015-07
• Study First Submitted: 2015-07-23
• Study First Submitted QC: 2015-07-23
• Study First Posted: 2015-07-24
• Last Update Submitted: 2015-07-29
• Last Update Posted: 2015-07-30
• Primary Completion: 2016-08
• Study Completion: 2016-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 126

Inclusion Criteria

• Adult patients
• Presenting to the emergency department with abdominal cramps associated with acute gastroenteritis
• The pain intensity score upon screening is at least 20 mm on visual analog scale
• Patients who agree to participate and sign the informed consent

Exclusion Criteria

• Patients younger than 18 years
• Pain of > 7 days
• Use of any analgesic within 6 hours of ED presentation
• Concomitant medication with spasmolytics, anticholinergics, drugs affecting gastrointestinal motility such as metoclopramide, loperamide, opioid analgesics
• Patients who were administered dopamine antagonists before screening
• Documented or self-reported hypersensitivity to hyoscine-n-butylbromide
• Confirmed or suspected pregnancy
• Breastfeeding
• Glaucoma
• Myasthenia gravis
• Benign prostatic hyperplasia or urinary obstruction
• Any suspected other cause of acute abdominal pain
• Peritonism
• Mechanical stenosis of the gastrointestinal tract, paralytic ileus, megacolon
• Previous intestinal resection
• History of inflammatory bowel disease
• Tachyarrhythmia
• Severe dehydration requiring fluid resuscitation immediately
• Unable to consent
• Refused to participate

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Hyoscine-N-Butylbromide	Hyoscine-N-Butylbromide	20 mg Hyoscine-N-Butylbromide in 98 mL normal saline (totally 100 mL)
Placebo	Hyoscine-N-Butylbromide	100 mL normal saline

Primary Outcome Measures

Name	Time	Method
Change in the mean pain intensity scores on visual analog scale	15, 30, 60 minutes	Change in the mean pain intensity scores on visual analog scale

Secondary Outcome Measures

Name	Time	Method
Adverse events	6 hours	any adverse reactions
Incidence of rescue analgesia	at 30 minute	Incidence of rescue analgesia (Fentanyl 1mcg/kg) requirement

Trial Locations

Locations (1)

Kocaeli University, Faculty of Medicine, Emergency Departmentt; 🇹🇷 Kocaeli, Turkey