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

Kocaeli University126 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

126

Conditions

Abdominal Cramps

Interventions

Hyoscine-N-ButylbromideDRUG

Study Drug: 20 mg/2 mL Hyoscine-N-Butylbromide in 98 mL normal saline (totally 100 mL) ıntravenous form of Hyoscine-N-Butylbromide in normal saline is in the same appearance with placebo Study drug: 100 mL normal saline (placebo) (totally 100 mL) Drug: Fentanyl 1 mcg/kg as rescue analgesia at 30th minute

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Kocaeli University, Faculty of Medicine, Emergency Departmentt

Kocaeli, Turkey (Türkiye)

RECRUITING

Outcomes

Primary Outcomes

Change in the mean pain intensity scores on visual analog scale

Time frame: 15, 30, 60 minutes

Secondary Outcomes

Adverse events

any adverse reactions

Time frame: 6 hours

Incidence of rescue analgesia

Incidence of rescue analgesia (Fentanyl 1mcg/kg) requirement

Time frame: at 30 minute

Central Contacts

Elif YAKA, M.D.

CONTACT

+90 262 3038551 elifpostaciyaka@gmail.com

İbrahim U. Özturan, M.D.

CONTACT

+90 262 3038577 ozturan.iu@gmail.com

Data from ClinicalTrials.gov

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