Analgesic Efficacy of Intravenous Hyoscine-N-Butylbromide (HNB) in Abdominal Colic Associated With Acute Gastroenteritis (HNB)
Primary Purpose
Abdominal Cramps
Status
Unknown status
Phase
Phase 4
Locations
Turkey
Study Type
Interventional
Intervention
Hyoscine-N-Butylbromide
Sponsored by
About this trial
This is an interventional treatment trial for Abdominal Cramps
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
Sites / Locations
- Kocaeli University, Faculty of Medicine, Emergency DepartmenttRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Hyoscine-N-Butylbromide
Placebo
Arm Description
20 mg Hyoscine-N-Butylbromide in 98 mL normal saline (totally 100 mL)
100 mL normal saline
Outcomes
Primary Outcome Measures
Change in the mean pain intensity scores on visual analog scale
Change in the mean pain intensity scores on visual analog scale
Secondary Outcome Measures
Adverse events
any adverse reactions
Incidence of rescue analgesia
Incidence of rescue analgesia (Fentanyl 1mcg/kg) requirement
Full Information
NCT ID
NCT02508142
First Posted
July 23, 2015
Last Updated
July 29, 2015
Sponsor
Kirsehir Ahi Evran University
1. Study Identification
Unique Protocol Identification Number
NCT02508142
Brief Title
Analgesic Efficacy of Intravenous Hyoscine-N-Butylbromide (HNB) in Abdominal Colic Associated With Acute Gastroenteritis
Acronym
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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2015
Overall Recruitment Status
Unknown status
Study Start Date
July 2015 (undefined)
Primary Completion Date
August 2016 (Anticipated)
Study Completion Date
August 2016 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kirsehir Ahi Evran University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Abdominal Cramps
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
126 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Hyoscine-N-Butylbromide
Arm Type
Active Comparator
Arm Description
20 mg Hyoscine-N-Butylbromide in 98 mL normal saline (totally 100 mL)
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
100 mL normal saline
Intervention Type
Drug
Intervention Name(s)
Hyoscine-N-Butylbromide
Other Intervention Name(s)
Buscopan, 20mg/2 mL (Boehringer Ingelheim İlaç Ticaret A.Ş)
Intervention Description
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
Primary Outcome Measure Information:
Title
Change in the mean pain intensity scores on visual analog scale
Description
Change in the mean pain intensity scores on visual analog scale
Time Frame
15, 30, 60 minutes
Secondary Outcome Measure Information:
Title
Adverse events
Description
any adverse reactions
Time Frame
6 hours
Title
Incidence of rescue analgesia
Description
Incidence of rescue analgesia (Fentanyl 1mcg/kg) requirement
Time Frame
at 30 minute
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Elif YAKA, M.D.
Phone
+90 262 3038551
Email
elifpostaciyaka@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
İbrahim U. Özturan, M.D.
Phone
+90 262 3038577
Email
ozturan.iu@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elif YAKA, M.D.
Organizational Affiliation
Kocaeli University, Faculty of Medicine, Emergency Department
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kocaeli University, Faculty of Medicine, Emergency Departmentt
City
Kocaeli
ZIP/Postal Code
41380
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elif Yaka, M.D.
Phone
+902623038551
Email
elifpostaciyaka@gmail.com
First Name & Middle Initial & Last Name & Degree
İbrahim U Özturan, M.D.
Phone
+902623038577
Email
ozturan.iu@gmail.com
12. IPD Sharing Statement
Learn more about this trial
Analgesic Efficacy of Intravenous Hyoscine-N-Butylbromide (HNB) in Abdominal Colic Associated With Acute Gastroenteritis
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