Management of Abdominal Pain in Acute Gastroenteritis Patients With Hyoscine Butylbromide

NCT ID: NCT04682860

Last Updated: 2022-01-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-09-08

Study Completion Date

2022-01-03

Brief Summary

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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.

Detailed Description

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Conditions

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Acute Gastroenteritis Abdominal Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Placebo

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

2 ml of normal saline injection as placebo

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.

Group Type ACTIVE_COMPARATOR

Hyoscine N Butylbromide

Intervention Type DRUG

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

Interventions

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Hyoscine N Butylbromide

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

Intervention Type DRUG

Placebo

2 ml of normal saline injection as placebo

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ankara City Hospital Bilkent

OTHER

Sponsor Role lead

Responsible Party

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Cagdas Yildirim

Ass. Prof.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Çağdaş Yıldırım, Ass. Prof

Role: PRINCIPAL_INVESTIGATOR

Ankara City Hospital Bilkent

Locations

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Ankara City Hospital

Ankara, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type BACKGROUND
PMID: 22307926 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25358721 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29194529 (View on PubMed)

Other Identifiers

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Çağdaş Yıldırım

Identifier Type: -

Identifier Source: org_study_id

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