Management of Abdominal Pain in Acute Gastroenteritis Patients With Hyoscine Butylbromide

Abdominal Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04682860
• Other study ID #: Çagdas Yildirim
• Status: Completed
• Phase: Phase 4
• Start date: September 8, 2021
• Est. completion date: January 3, 2022

Study information

• Verified date: January 2022
• Source: Ankara City Hospital Bilkent
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: January 3, 2022
• Est. primary completion date: December 3, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Abdominal Pain
• Acute Gastroenteritis
• Gastroenteritis

Intervention

Drug:
• Hyoscine N Butylbromide
Hyoscine N butylbromide injection for the treatment of abdominal pain in acute gastroenteritis

Other:
• Placebo
2 ml of normal saline injection as placebo

Locations

Country	Name	City	State
Turkey	Ankara City Hospital	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Ankara City Hospital Bilkent

Country where clinical trial is conducted

Turkey, 

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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