Analgesic Efficacy of Intravenous Hyoscine-N-Butylbromide (HNB) in Abdominal Colic Associated With Acute Gastroenteritis
NCT ID: NCT02508142
Last Updated: 2015-07-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
126 participants
INTERVENTIONAL
2015-07-31
2016-08-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Hyoscine-N-Butylbromide
20 mg Hyoscine-N-Butylbromide in 98 mL normal saline (totally 100 mL)
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
Placebo
100 mL normal saline
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
Interventions
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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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Kocaeli University
OTHER
Responsible Party
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Elif Yaka
Assistant Professor
Principal Investigators
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Elif YAKA, M.D.
Role: PRINCIPAL_INVESTIGATOR
Kocaeli University, Faculty of Medicine, Emergency Department
Locations
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Kocaeli University, Faculty of Medicine, Emergency Departmentt
Kocaeli, , Turkey (Türkiye)
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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KocaeliU
Identifier Type: -
Identifier Source: org_study_id
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