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

Last updated: July 29, 2015
Sponsor: Kocaeli University
Overall Status: Trial Status Unknown

Phase

4

Condition

Dysmenorrhea (Painful Periods)

Gastroenteritis

Colic

Treatment

N/A

Clinical Study ID

NCT02508142
KocaeliU
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Adult patients

  • Presenting to the emergency department with abdominal cramps associated with acutegastroenteritis

  • 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

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 affectinggastrointestinal 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

Total Participants: 126
Study Start date:
July 01, 2015
Estimated Completion Date:
August 31, 2016

Study 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.

Connect with a study center

  • Kocaeli University, Faculty of Medicine, Emergency Departmentt

    Kocaeli, 41380
    Turkey

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.