Management of Abdominal Pain in Acute Gastroenteritis Patients With Hyoscine Butylbromide

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.

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Key information

Conditions

Acute Gastroenteritis Abdominal Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Ankara City Hospital

Ankara, 06100, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Hyoscine N Butylbromide

Drug

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

Placebo

Other

2 ml of normal saline injection as placebo

Primary outcomes

Pain Change

Time frame: 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.

Sponsors and collaborators

Lead sponsor

Ankara City Hospital Bilkent

Other

Registry information

Official study title

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

Important dates

Study start: 2021
Primary completion: 2021
Study completion: 2022
First posted: Dec 24, 2020
Registry last updated: Jan 4, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed