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Management of Abdominal Pain in Acute Gastroenteritis Patients With Hyoscine Butylbromide

Management of Abdominal Pain in Acute Gastroenteritis Patients With Hyoscine Butylbromide: Randomized Double Blind Placebo Controlled Trial

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04682860
Enrollment
50
Registered
2020-12-24
Start date
2021-09-08
Completion date
2022-01-03
Last updated
2022-01-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Abdominal Pain, Acute Gastroenteritis

Brief summary

One of the most common complaints of admission to the emergency room is gastroenteritis. One of the most common complaints in acute gastroenteritis is abdominal pain. The aim of our study is to investigate whether hyoscine butylbromide used within the indication has an effect on abdominal pain due to acute gastroenteritis. The main purpose of our study is to reduce the pain of the patient at 30th and 60th minutes compared to 0th minute.

Interventions

Hyoscine N butylbromide injection for the treatment of abdominal pain in acute gastroenteritis

OTHERPlacebo

2 ml of normal saline injection as placebo

Sponsors

Ankara City Hospital Bilkent
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

Inclusion criteria

* Patients with watery stools starting in the last 2 weeks and 3 times in 24 hours and abdominal pain

Exclusion criteria

* Peritonitis * Hemodynamic instability * Pregnancy * Inability to give consent * Medication given in the emergency room before being included in the study * Taking pain medication within 4 hours * Diabetes Mellitus and other neuropathic diseases

Design outcomes

Primary

MeasureTime frameDescription
Pain Change30 minute and1 hourPain change after intervention at 30th and 60th minute. Pain will assesed with Visual Analog Scale (100 mm). 13 mm of change at Visual Analog Scale will assesed as clinically significant.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026