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

• Status: Unknown status
• Trial end date: 2016-08-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Kocaeli University
• Treatments: Analgesics; Butylscopolammonium Bromide; Scopolamine; Scopolamine Hydrobromide

Criteria

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