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Management of Abdominal Pain in Acute Gastroenteritis Patients With Hyoscine Butylbromide

Primary Purpose

Acute Gastroenteritis, Abdominal Pain

Status
Completed
Phase
Phase 4
Locations
Turkey
Study Type
Interventional
Intervention
Hyoscine N Butylbromide
Placebo
Sponsored by
Ankara City Hospital Bilkent
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Gastroenteritis

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Ankara City Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Placebo

Hyoscine N butylbromide

Arm Description

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

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
December 14, 2020
Last Updated
January 3, 2022
Sponsor
Ankara City Hospital Bilkent
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1. Study Identification

Unique Protocol Identification Number
NCT04682860
Brief Title
Management of Abdominal Pain in Acute Gastroenteritis Patients With Hyoscine Butylbromide
Official Title
Management of Abdominal Pain in Acute Gastroenteritis Patients With Hyoscine Butylbromide: Randomized Double Blind Placebo Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
September 8, 2021 (Actual)
Primary Completion Date
December 3, 2021 (Actual)
Study Completion Date
January 3, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ankara City Hospital Bilkent

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Gastroenteritis, Abdominal Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
In the placebo arm, patients will be slowly injected with 2 ml of normal saline within 30 seconds
Arm Title
Hyoscine N butylbromide
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Hyoscine N Butylbromide
Intervention Description
Hyoscine N butylbromide injection for the treatment of abdominal pain in acute gastroenteritis
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
2 ml of normal saline injection as placebo
Primary Outcome Measure Information:
Title
Pain Change
Description
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.
Time Frame
30 minute and1 hour

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Çağdaş Yıldırım, Ass. Prof
Organizational Affiliation
Ankara City Hospital Bilkent
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ankara City Hospital
City
Ankara
ZIP/Postal Code
06100
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
IPD maybe shared upon request
Citations:
PubMed Identifier
22307926
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.
Results Reference
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PubMed Identifier
25358721
Citation
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.
Results Reference
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PubMed Identifier
29194529
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.
Results Reference
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Management of Abdominal Pain in Acute Gastroenteritis Patients With Hyoscine Butylbromide

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