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

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

Sponsors

Lead Sponsor: Kocaeli University

Source Kocaeli University
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.

Overall Status Unknown status
Start Date July 2015
Completion Date August 2016
Primary Completion Date August 2016
Phase Phase 4
Study Type Interventional
Primary Outcome
Measure Time Frame
Change in the mean pain intensity scores on visual analog scale 15, 30, 60 minutes
Secondary Outcome
Measure Time Frame
Adverse events 6 hours
Incidence of rescue analgesia at 30 minute
Enrollment 126
Condition
Intervention

Intervention Type: Drug

Intervention Name: Hyoscine-N-Butylbromide

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

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

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

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Elif YAKA, M.D. Principal Investigator Kocaeli University, Faculty of Medicine, Emergency Department
Overall Contact

Last Name: Elif YAKA, M.D.

Phone: +90 262 3038551

Email: [email protected]

Location
Facility: Status: Contact: Contact Backup: Kocaeli University, Faculty of Medicine, Emergency Departmentt Elif Yaka, M.D. +902623038551 [email protected]
Location Countries

Turkey

Verification Date

July 2015

Responsible Party

Type: Principal Investigator

Investigator Affiliation: Kocaeli University

Investigator Full Name: Elif Yaka

Investigator Title: Assistant Professor

Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: Hyoscine-N-Butylbromide

Type: Active Comparator

Description: 20 mg Hyoscine-N-Butylbromide in 98 mL normal saline (totally 100 mL)

Label: Placebo

Type: Placebo Comparator

Description: 100 mL normal saline

Acronym HNB
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Source: ClinicalTrials.gov