- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04682860
Management of Abdominal Pain in Acute Gastroenteritis Patients With Hyoscine Butylbromide
January 3, 2022 updated by: Cagdas Yildirim, Ankara City Hospital Bilkent
Management of Abdominal Pain in Acute Gastroenteritis Patients With Hyoscine Butylbromide: Randomized Double Blind Placebo Controlled Trial
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
50
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Ankara, Turkey, 06100
- Ankara City Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 63 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Placebo
In the placebo arm, patients will be slowly injected with 2 ml of normal saline within 30 seconds
|
2 ml of normal saline injection as placebo
|
Active Comparator: 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.
|
Hyoscine N butylbromide injection for the treatment of abdominal pain in acute gastroenteritis
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
30 minute and1 hour
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Çağdaş Yıldırım, Ass. Prof, Ankara City Hospital Bilkent
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 8, 2021
Primary Completion (Actual)
December 3, 2021
Study Completion (Actual)
January 3, 2022
Study Registration Dates
First Submitted
December 14, 2020
First Submitted That Met QC Criteria
December 19, 2020
First Posted (Actual)
December 24, 2020
Study Record Updates
Last Update Posted (Actual)
January 4, 2022
Last Update Submitted That Met QC Criteria
January 3, 2022
Last Verified
January 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Pain
- Neurologic Manifestations
- Signs and Symptoms, Digestive
- Gastrointestinal Diseases
- Abdominal Pain
- Gastroenteritis
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Parasympatholytics
- Autonomic Agents
- Peripheral Nervous System Agents
- Muscarinic Antagonists
- Cholinergic Antagonists
- Cholinergic Agents
- Antiemetics
- Gastrointestinal Agents
- Adjuvants, Anesthesia
- Mydriatics
- Scopolamine
- Butylscopolammonium Bromide
Other Study ID Numbers
- Çağdaş Yıldırım
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
IPD Plan Description
IPD maybe shared upon request
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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