Clinical trial NCT02508142: Analgesic Efficacy of Intravenous Hyoscine-N-Butylbromide (HNB) in Abdominal Colic Associated With Acute Gastroenteritis
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
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Abdominal Cramps
Lead sponsor: Kocaeli University
Sponsor class: OTHER
First posted: 2015-07-24
Enrollment: 126
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change in the mean pain intensity scores on visual analog scale
timeFrame: 15, 30, 60 minutes
Secondary outcomes:
measure: Adverse events
timeFrame: 6 hours
measure: Incidence of rescue analgesia
timeFrame: at 30 minute
Other outcomes:
Locations:
city: Kocaeli
country: Turkey
facility: Kocaeli University, Faculty of Medicine, Emergency Departmentt
Study officials:
affiliation: Kocaeli University, Faculty of Medicine, Emergency Department
name: Elif YAKA, M.D.
role: PRINCIPAL_INVESTIGATOR
References: