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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02508142
Other study ID # KocaeliU
Secondary ID
Status Recruiting
Phase Phase 4
First received July 23, 2015
Last updated July 29, 2015
Start date July 2015
Est. completion date August 2016

Study information

Verified date July 2015
Source Kocaeli University
Contact Elif YAKA, M.D.
Phone +90 262 3038551
Email elifpostaciyaka@gmail.com
Is FDA regulated No
Health authority Turkey: Ministry of Health
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 126
Est. completion date August 2016
Est. primary completion date August 2016
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
Hyoscine-N-Butylbromide
Study Drug: 20 mg/2 mL Hyoscine-N-Butylbromide in 98 mL normal saline (totally 100 mL) intravenous 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

Locations

Country Name City State
Turkey Kocaeli University, Faculty of Medicine, Emergency Departmentt Kocaeli

Sponsors (1)

Lead Sponsor Collaborator
Kocaeli University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in the mean pain intensity scores on visual analog scale Change in the mean pain intensity scores on visual analog scale 15, 30, 60 minutes No
Secondary Adverse events any adverse reactions 6 hours Yes
Secondary Incidence of rescue analgesia Incidence of rescue analgesia (Fentanyl 1mcg/kg) requirement at 30 minute Yes
See also
  Status Clinical Trial Phase
Completed NCT00881322 - A Study on Intestinal Gas Symptoms to Evaluate the Effects of Gas Defense in Otherwise Healthy Adult N/A