Clincosm LogoSign in Get a demo

Management of Abdominal Pain in Acute Gastroenteritis Patients With Hyoscine Butylbromide

Sponsor
Ankara City Hospital Bilkent (Other)
Overall Status
Completed
CT.gov ID
NCT04682860
Collaborator
(none)
50
Enrollment
1
Location
2
Arms
3.8
Actual Duration (Months)
13
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Hyoscine N Butylbromide
  • Other: Placebo
 Phase 4

Study Design

Study Type:
Interventional
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 :
Sep 8, 2021
Actual Primary Completion Date :
Dec 3, 2021
Actual Study Completion Date :
Jan 3, 2022

Arms and Interventions

Arm Intervention/Treatment
Placebo Comparator: Placebo

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

Other: Placebo
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.

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

Outcome Measures

Primary Outcome Measures

  1. Pain Change [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Ankara City Hospital Ankara Turkey 06100

Sponsors and Collaborators

  • Ankara City Hospital Bilkent

Investigators

  • Principal Investigator: Çağdaş Yıldırım, Ass. Prof, Ankara City Hospital Bilkent

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Cagdas Yildirim, Ass. Prof., Ankara City Hospital Bilkent
ClinicalTrials.gov Identifier:
NCT04682860
Other Study ID Numbers:
  • Çağdaş Yıldırım
First Posted:
Dec 24, 2020
Last Update Posted:
Jan 4, 2022
Last Verified:
Jan 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Gastroenteritis
Abdominal Pain
Scopolamine
Butylscopolammonium Bromide

Study Results

No Results Posted as of Jan 4, 2022