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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02508142
Recruitment Status : Unknown
Verified July 2015 by Elif Yaka, Kocaeli University.
Recruitment status was:  Recruiting
First Posted : July 24, 2015
Last Update Posted : July 30, 2015
Sponsor:
Information provided by (Responsible Party):
Elif Yaka, Kocaeli University

Study Description
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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.

Condition or disease Intervention/treatment Phase
Abdominal Cramps Drug: Hyoscine-N-Butylbromide Phase 4

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 126 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Study Start Date : July 2015
Estimated Primary Completion Date : August 2016
Estimated Study Completion Date : August 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Gastroenteritis

Arms and Interventions
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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 Name: 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 Name: Buscopan, 20mg/2 mL (Boehringer Ingelheim İlaç Ticaret A.Ş)


Outcome Measures
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Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Adverse events [ Time Frame: 6 hours ]
    any adverse reactions

  2. Incidence of rescue analgesia [ Time Frame: at 30 minute ]
    Incidence of rescue analgesia (Fentanyl 1mcg/kg) requirement


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02508142


Contacts
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Contact: Elif YAKA, M.D. +90 262 3038551 elifpostaciyaka@gmail.com
Contact: İbrahim U. Özturan, M.D. +90 262 3038577 ozturan.iu@gmail.com

Locations
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Turkey
Kocaeli University, Faculty of Medicine, Emergency Departmentt Recruiting
Kocaeli, Turkey, 41380
Contact: Elif Yaka, M.D.    +902623038551    elifpostaciyaka@gmail.com   
Contact: İbrahim U Özturan, M.D.    +902623038577    ozturan.iu@gmail.com   
Sponsors and Collaborators
Kocaeli University
Investigators
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Principal Investigator: Elif YAKA, M.D. Kocaeli University, Faculty of Medicine, Emergency Department
More Information
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Responsible Party: Elif Yaka, Assistant Professor, Kocaeli University
ClinicalTrials.gov Identifier: NCT02508142    
Other Study ID Numbers: KocaeliU
First Posted: July 24, 2015    Key Record Dates
Last Update Posted: July 30, 2015
Last Verified: July 2015
Additional relevant MeSH terms:
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Gastroenteritis
Colic
Gastrointestinal Diseases
Digestive System Diseases
Infant, Newborn, Diseases
Scopolamine
Butylscopolammonium Bromide
Adjuvants, Anesthesia
Antiemetics
Autonomic Agents
 Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Mydriatics
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Muscarinic Antagonists
Parasympatholytics