Analgesic Efficacy of Intravenous Hyoscine-N-Butylbromide (HNB) in Abdominal Colic Associated With Acute Gastroenteritis (HNB)

July 29, 2015 updated by: Elif Yaka, Kocaeli University

Assessment of Analgesic Efficacy and Safety of Intravenous Hyoscine-N-Butylbromide in Patients With Abdominal Colic Associated With Acute Gastroenteritis; a Randomized, Double-blind, Placebo Controlled Study

This study aims to assess the analgesic efficacy and safety of intravenous 20 mg Hyoscine-N-Butylbromide versus placebo for the treatment of abdominal colic associated with acute gastroenteritis in the emergency department.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Acute gastroenteritis is a frequent cause of emergency department (ED) presentation. Mainstays of ED treatment are rehydration and antiemetics when needed. Since crampy abdominal pain accompanies (diarrhea) acute gastroenteritis in 67-90% of patients, emergency physicians may have to deal with spasmodic colics in these patients.

Hyoscine-N-butylbromide (HNB), is an anticholinergic agent which has been in use as an antispasmodic agent for sixty years all over the world. It has been studied and revealed various efficacy for several conditions (e.g; biliary colic, renal colic, endoscopic interventions, radiologic interventions, during labor, nonspecific abdominal pain and irritable bowel syndrome).

HNB is commonly used for symptomatic relief of abdominal cramps associated with acute gastroenteritis in the EDs, whereas the literature lacks evidence regarding its efficacy and safety for this condition.

The aim of this study is to assess the analgesic efficacy and safety of intravenous 20 mg hyoscine-n-butylbromide versus placebo in patients with abdominal colic associated with acute gastroenteritis in the emergency department.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
126

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Turkey
      • Kocaeli, Turkey, 41380
        • Recruiting
        • Kocaeli University, Faculty of Medicine, Emergency Departmentt
        • Contact:
        • Contact:

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Adult patients
  • Presenting to the emergency department with abdominal cramps associated with acute gastroenteritis
  • The pain intensity score upon screening is at least 20 mm on visual analog scale
  • Patients who agree to participate and sign the informed consent

Exclusion Criteria:

  • Patients younger than 18 years
  • Pain of > 7 days
  • Use of any analgesic within 6 hours of ED presentation
  • Concomitant medication with spasmolytics, anticholinergics, drugs affecting gastrointestinal motility such as metoclopramide, loperamide, opioid analgesics
  • Patients who were administered dopamine antagonists before screening
  • Documented or self-reported hypersensitivity to hyoscine-n-butylbromide
  • Confirmed or suspected pregnancy
  • Breastfeeding
  • Glaucoma
  • Myasthenia gravis
  • Benign prostatic hyperplasia or urinary obstruction
  • Any suspected other cause of acute abdominal pain
  • Peritonism
  • Mechanical stenosis of the gastrointestinal tract, paralytic ileus, megacolon
  • Previous intestinal resection
  • History of inflammatory bowel disease
  • Tachyarrhythmia
  • Severe dehydration requiring fluid resuscitation immediately
  • Unable to consent
  • Refused to participate

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: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Hyoscine-N-Butylbromide
20 mg Hyoscine-N-Butylbromide in 98 mL normal saline (totally 100 mL)
Drug: Hyoscine-N-Butylbromide

Study Drug: 20 mg/2 mL Hyoscine-N-Butylbromide in 98 mL normal saline (totally 100 mL) ıntravenous form of Hyoscine-N-Butylbromide in normal saline is in the same appearance with placebo Study drug: 100 mL normal saline (placebo) (totally 100 mL)

Drug: Fentanyl 1 mcg/kg as rescue analgesia at 30th minute

Other Names:
  • Buscopan, 20mg/2 mL (Boehringer Ingelheim İlaç Ticaret A.Ş)
Placebo Comparator: Placebo
100 mL normal saline
Drug: Hyoscine-N-Butylbromide

Study Drug: 20 mg/2 mL Hyoscine-N-Butylbromide in 98 mL normal saline (totally 100 mL) ıntravenous form of Hyoscine-N-Butylbromide in normal saline is in the same appearance with placebo Study drug: 100 mL normal saline (placebo) (totally 100 mL)

Drug: Fentanyl 1 mcg/kg as rescue analgesia at 30th minute

Other Names:
  • Buscopan, 20mg/2 mL (Boehringer Ingelheim İlaç Ticaret A.Ş)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in the mean pain intensity scores on visual analog scale
Time Frame: 15, 30, 60 minutes
Change in the mean pain intensity scores on visual analog scale
15, 30, 60 minutes

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Adverse events
Time Frame: 6 hours
any adverse reactions
6 hours
Incidence of rescue analgesia
Time Frame: at 30 minute
Incidence of rescue analgesia (Fentanyl 1mcg/kg) requirement
at 30 minute

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Kocaeli University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Elif YAKA, M.D., Kocaeli University, Faculty of Medicine, Emergency Department

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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2015

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2016

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 23, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 23, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 24, 2015

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 30, 2015

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 29, 2015

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • KocaeliU

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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