Abdominal Cramps Clinical Trial
— HNBOfficial 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
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.
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Turkey | Kocaeli University, Faculty of Medicine, Emergency Departmentt | Kocaeli |
Lead Sponsor | Collaborator |
---|---|
Kocaeli University |
Turkey,
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 |
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 |