Management of Abdominal Pain in Acute Gastroenteritis Patients With Hyoscine Butylbromide

Phase 4

Completed

• Conditions: Acute Gastroenteritis; Abdominal Pain
• Interventions: Drug: Hyoscine N Butylbromide; Other: Placebo

• Registration Number: NCT04682860
• Lead Sponsor: Ankara City Hospital Bilkent

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-12-14
• Study First Submitted QC: 2020-12-19
• Study First Posted: 2020-12-24
• Study Start: 2021-09-08
• Primary Completion: 2021-12-03
• Status Verified: 2022-01
• Study Completion: 2022-01-03
• Last Update Submitted: 2022-01-03
• Last Update Posted: 2022-01-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Hyoscine N butylbromide	Hyoscine N Butylbromide	In the treatment arm, the patient will be injected intravenously with 1ml 20 mg of Hyoscine butylbromide and 1 ml of normal saline intravenously within 30 seconds.
Placebo	Placebo	In the placebo arm, patients will be slowly injected with 2 ml of normal saline within 30 seconds

Primary Outcome Measures

Name	Time	Method
Pain Change	30 minute and1 hour	Pain 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.

Trial Locations

Locations (1)

Ankara City Hospital; 🇹🇷 Ankara, Turkey