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