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

Kocaeli University

Status and phase: Unknown; Phase 4

Conditions: Abdominal Cramps

Treatments: Drug: Hyoscine-N-Butylbromide

Study type: Interventional

Funder types: Other

Identifiers

NCT02508142

KocaeliU

Details and patient eligibility

About

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.

Full 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.

Enrollment: 126 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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126 participants in 2 patient groups, including a placebo group

Hyoscine-N-Butylbromide

Active Comparator group

Description:

20 mg Hyoscine-N-Butylbromide in 98 mL normal saline (totally 100 mL)

Treatment:

Drug: Hyoscine-N-Butylbromide

Placebo

Placebo Comparator group

Description:

100 mL normal saline

Treatment:

Drug: Hyoscine-N-Butylbromide