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

Study Overview
=================
Brief 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.

Detailed 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.

Official Title
-----------------
Assessment of Analgesic Efficacy and Safety of Intravenous Hyoscine-N-Butylbromide in Patients With Abdominal Colic Associated With Acute Gastroenteritis; a Randomized, Double-blind, Placebo Controlled Study

Conditions
-----------------
Abdominal Cramps

Intervention / Treatment
-----------------
* Drug: Hyoscine-N-Butylbromide


Participation Criteria
=================
Eligibility 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Hyoscine-N-Butylbromide<br>20 mg Hyoscine-N-Butylbromide in 98 mL normal saline (totally 100 mL) | Drug: Hyoscine-N-Butylbromide<br>* 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<br>* Other names: Buscopan, 20mg/2 mL (Boehringer Ingelheim İlaç Ticaret A.Ş);|
| Placebo Comparator: Placebo<br>100 mL normal saline | Drug: Hyoscine-N-Butylbromide<br>* 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<br>* Other names: Buscopan, 20mg/2 mL (Boehringer Ingelheim İlaç Ticaret A.Ş);|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in the mean pain intensity scores on visual analog scale | Change in the mean pain intensity scores on visual analog scale | 15, 30, 60 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events | any adverse reactions | 6 hours | 
| Incidence of rescue analgesia | Incidence of rescue analgesia (Fentanyl 1mcg/kg) requirement | at 30 minute |