Abdominal Cramps Clinical Trial
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
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.
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
| 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 |