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

Abdominal Cramps Clinical Trial

— HNB  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02508142
• Other study ID #: KocaeliU
• Status: Recruiting
• Phase: Phase 4
• First received: July 23, 2015
• Last updated: July 29, 2015
• Start date: July 2015
• Est. completion date: August 2016

Study information

• Verified date: July 2015
• Source: Kocaeli University
• Contact: Elif YAKA, M.D.
• Phone: +90 262 3038551
• Email: elifpostaciyaka[@]gmail.com
• Is FDA regulated: No
• Health authority: Turkey: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 126
• Est. completion date: August 2016
• Est. primary completion date: August 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Abdominal Cramps
• Colic
• Gastroenteritis

Intervention

Drug:
• Hyoscine-N-Butylbromide
Study Drug: 20 mg/2 mL Hyoscine-N-Butylbromide in 98 mL normal saline (totally 100 mL) intravenous 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

Locations

Country	Name	City	State
Turkey	Kocaeli University, Faculty of Medicine, Emergency Departmentt	Kocaeli

Sponsors (1)

Lead Sponsor	Collaborator
Kocaeli University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Adverse events	any adverse reactions	6 hours	Yes
Secondary	Incidence of rescue analgesia	Incidence of rescue analgesia (Fentanyl 1mcg/kg) requirement	at 30 minute	Yes