Abdominal Cramps
Conditions
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.
Interventions
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
Sponsors
Kocaeli University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in the mean pain intensity scores on visual analog scale | 15, 30, 60 minutes | Change in the mean pain intensity scores on visual analog scale |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adverse events | 6 hours | any adverse reactions |
| Incidence of rescue analgesia | at 30 minute | Incidence of rescue analgesia (Fentanyl 1mcg/kg) requirement |
Countries
Turkey (Türkiye)
Contacts
Primary ContactElif YAKA, M.D.
Backup Contactİbrahim U. Özturan, M.D.
Outcome results
None listed