Management of Abdominal Pain in Acute Gastroenteritis Patients With Hyoscine Butylbromide
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| ClinicalTrials.gov Identifier: NCT04682860 |
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Recruitment Status :
Completed
First Posted : December 24, 2020
Last Update Posted : January 4, 2022
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Sponsor:
Ankara City Hospital Bilkent
Information provided by (Responsible Party):
Cagdas Yildirim, Ankara City Hospital Bilkent
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Acute Gastroenteritis Abdominal Pain | Drug: Hyoscine N Butylbromide Other: Placebo | Phase 4 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 50 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Double (Participant, Investigator) |
| Primary Purpose: | Treatment |
| Official Title: | Management of Abdominal Pain in Acute Gastroenteritis Patients With Hyoscine Butylbromide: Randomized Double Blind Placebo Controlled Trial |
| Actual Study Start Date : | September 8, 2021 |
| Actual Primary Completion Date : | December 3, 2021 |
| Actual Study Completion Date : | January 3, 2022 |
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| Arm | Intervention/treatment |
|---|---|
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Placebo Comparator: Placebo
In the placebo arm, patients will be slowly injected with 2 ml of normal saline within 30 seconds
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Other: Placebo
2 ml of normal saline injection as placebo |
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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.
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Drug: Hyoscine N Butylbromide
Hyoscine N butylbromide injection for the treatment of abdominal pain in acute gastroenteritis |
Primary Outcome Measures :
- 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.
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| Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04682860
Locations
| Turkey | |
| Ankara City Hospital | |
| Ankara, Turkey, 06100 | |
Sponsors and Collaborators
Ankara City Hospital Bilkent
Investigators
| Principal Investigator: | Çağdaş Yıldırım, Ass. Prof | Ankara City Hospital Bilkent |
Publications:
| Responsible Party: | Cagdas Yildirim, Ass. Prof., Ankara City Hospital Bilkent |
| ClinicalTrials.gov Identifier: | NCT04682860 |
| Other Study ID Numbers: |
Çağdaş Yıldırım |
| First Posted: | December 24, 2020 Key Record Dates |
| Last Update Posted: | January 4, 2022 |
| Last Verified: | January 2022 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Plan Description: | IPD maybe shared upon request |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
Additional relevant MeSH terms:
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Gastroenteritis Abdominal Pain Pain Neurologic Manifestations Signs and Symptoms, Digestive Gastrointestinal Diseases Digestive System Diseases Scopolamine Butylscopolammonium Bromide Adjuvants, Anesthesia Antiemetics |
Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Gastrointestinal Agents Mydriatics Cholinergic Antagonists Cholinergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Muscarinic Antagonists Parasympatholytics |