Management of Abdominal Pain in Acute Gastroenteritis Patients With Hyoscine Butylbromide

NCT04682860 | Completed Phase 4

• 1 other identifier: Çağdaş Yıldırım
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Gastroenteritis; Abdominal Pain

Outcome Measures

Primary Outcomes (1)

• Pain Change

  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.

  30 minute and1 hour

Study Arms (2)

Placebo

PLACEBO COMPARATOR

In the placebo arm, patients will be slowly injected with 2 ml of normal saline within 30 seconds

Other: Placebo

Hyoscine N butylbromide

ACTIVE COMPARATOR

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.

Drug: Hyoscine N Butylbromide

Interventions

Hyoscine N Butylbromide DRUG

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

Hyoscine N butylbromide

Placebo OTHER

2 ml of normal saline injection as placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ankara City Hospital Bilkent: lead

Study Sites (1)

Ankara City Hospital

Ankara, 06100, Turkey (Türkiye)

Location

Related Publications (3)

• Remington-Hobbs J, Petts G, Harris T. Emergency department management of undifferentiated abdominal pain with hyoscine butylbromide and paracetamol: a randomised control trial. Emerg Med J. 2012 Dec;29(12):989-94. doi: 10.1136/emermed-2011-200474. Epub 2012 Feb 3.

  PMID: 22307926 BACKGROUND

• Arena C, Amoros JP, Vaillant V, Ambert-Balay K, Chikhi-Brachet R, Jourdan-Da Silva N, Varesi L, Arrighi J, Souty C, Blanchon T, Falchi A, Hanslik T. Acute diarrhea in adults consulting a general practitioner in France during winter: incidence, clinical characteristics, management and risk factors. BMC Infect Dis. 2014 Oct 30;14:574. doi: 10.1186/s12879-014-0574-4.

  PMID: 25358721 BACKGROUND

• Shane AL, Mody RK, Crump JA, Tarr PI, Steiner TS, Kotloff K, Langley JM, Wanke C, Warren CA, Cheng AC, Cantey J, Pickering LK. 2017 Infectious Diseases Society of America Clinical Practice Guidelines for the Diagnosis and Management of Infectious Diarrhea. Clin Infect Dis. 2017 Nov 29;65(12):1963-1973. doi: 10.1093/cid/cix959.

  PMID: 29194529 BACKGROUND

MeSH Terms

Conditions

Abdominal Pain

Interventions

Butylscopolammonium Bromide

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Digestive

Intervention Hierarchy (Ancestors)

Quaternary Ammonium Compounds; Amines; Organic Chemicals; Scopolamine Derivatives; Tropanes; Azabicyclo Compounds; Aza Compounds; Alkaloids; Heterocyclic Compounds; Bridged Bicyclo Compounds, Heterocyclic; Heterocyclic Compounds, Bridged-Ring

Study Officials

• Çağdaş Yıldırım, Ass. Prof

  Ankara City Hospital Bilkent

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ass. Prof.

Study Record Dates

• First Submitted: December 14, 2020
• First Posted: December 24, 2020
• Study Start: September 8, 2021
• Primary Completion: December 3, 2021
• Study Completion: January 3, 2022
• Last Updated: January 4, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)