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

July 29, 2015 updated by: Elif Yaka, Kocaeli University

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

126

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Kocaeli, Turkey, 41380
        • Recruiting
        • Kocaeli University, Faculty of Medicine, Emergency Departmentt
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Hyoscine-N-Butylbromide
20 mg Hyoscine-N-Butylbromide in 98 mL normal saline (totally 100 mL)
Drug: Hyoscine-N-Butylbromide

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

Other Names:
  • Buscopan, 20mg/2 mL (Boehringer Ingelheim İlaç Ticaret A.Ş)
Placebo Comparator: Placebo
100 mL normal saline
Drug: Hyoscine-N-Butylbromide

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

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
Time Frame: 15, 30, 60 minutes
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
Time Frame: 6 hours
any adverse reactions
6 hours
Incidence of rescue analgesia
Time Frame: at 30 minute
Incidence of rescue analgesia (Fentanyl 1mcg/kg) requirement
at 30 minute

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kocaeli University

Investigators

  • Principal Investigator: Elif YAKA, M.D., Kocaeli University, Faculty of Medicine, Emergency Department

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2015

Primary Completion (Anticipated)

August 1, 2016

Study Completion (Anticipated)

August 1, 2016

Study Registration Dates

First Submitted

July 23, 2015

First Submitted That Met QC Criteria

July 23, 2015

First Posted (Estimate)

July 24, 2015

Study Record Updates

Last Update Posted (Estimate)

July 30, 2015

Last Update Submitted That Met QC Criteria

July 29, 2015

Last Verified

July 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KocaeliU

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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