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Comparison of Efficacy Dimenhydrinate and Metoclopramide in the Treatment of Nausea Due to Vertigo

Primary Purpose

Nausea, Vomiting, Vertigo

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Dimenhydrinate
Metoclopramide
Sponsored by
Pamukkale University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Nausea focused on measuring Metoclopramide, Dimenhydrinate, emergency medicine

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • between 18 to 65 years old patients,
  • had vertigo and accompanied nausea or vomiting [VAS (visual analog scale) score >5] during their emergency department episode of care for which the attending physician recommended intravenous antiemetic medication.

Exclusion Criteria:

  • abnormal vital signs,
  • women who were pregnant or lactation,
  • those with a history of epilepsy,
  • acute psychiatric symptoms,
  • organic brain disease,
  • parkinson's disease or phaeochromocytoma,
  • or any known allergy to the study drugs,
  • uncooperative individuals,
  • use of any antiemetic drug in the previous 8 hours or previous delivery of intravenous fluids during the emergency department episode of care,
  • currently undergoing chemotherapy or radiotherapy,
  • mechanical obstruction or perforation,
  • gastrointestinal bleeding,
  • inability to understand study explanation or outcome measures (any reason),
  • known allergy or previous adverse reaction to metoclopramide or dimenhydrinate,
  • and patients who refused to participate study.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    Dimenhydrinate

    Metoclopramide

    Arm Description

    50 mg Dimenhydrinate with 5 cc syringe in 150 ml normal saline given as a slow intravenous infusion over 15 minutes

    10 mg Metoclopramide with 5 cc syringe in 150 ml normal saline given as a slow intravenous infusion over 15 minutes

    Outcomes

    Primary Outcome Measures

    compare the effects of intravenous dimenhydrinate and metoclopramide in the treatment of nausea due to vertigo in emergency setting. (nausea and vertigo scores as measured by Visual Analogue Scale.)
    - participants will be followed for the duration of hospital stay, an expected average of 30 minutes.

    Secondary Outcome Measures

    Full Information

    First Posted
    September 9, 2014
    Last Updated
    September 27, 2014
    Sponsor
    Pamukkale University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02253524
    Brief Title
    Comparison of Efficacy Dimenhydrinate and Metoclopramide in the Treatment of Nausea Due to Vertigo
    Official Title
    Comparison of Efficacy Dimenhydrinate and Metoclopramide in the Treatment of Nausea Due to Vertigo
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2014
    Overall Recruitment Status
    Completed
    Study Start Date
    November 2012 (undefined)
    Primary Completion Date
    May 2013 (Actual)
    Study Completion Date
    May 2013 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Pamukkale University

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    Vertigo complaint is one of the common cause of patients who applied to emergency services. Patients who have applied to emergency services with vertigo complaint mostly have nausea as an additionally symptom to this complaint and anti-emetic agents can be used in their treatments very often. The investigators purpose is to investigate the advantages of Dimenhydrinate and metoclopramide to each other in the treatment of vertigo and the vertigo accompanied by nausea
    Detailed Description
    Vertigo describes the illusion of being subject to an involuntary movement, usually rotational, of the patient or the patient's surroundings which is caused by sudden tonic neural activity. The management and episodic treatment of patients with spontaneous vertigo related nausea-vomiting symptoms are somewhat controversial in the emergency department setting. Patients admitted to the emergency department with complaints of vertigo in addition to a large portion of the symptoms are accompanied by nausea and antiemetic agents are frequently used in the treatment. An ideal treatment should be rapid in onset and effective, and lack debilitating side effects. Although a wide variety of classes of pharmacologic agents and modalities are used, the emergency department treatment of acute spontaneous vertigo and associated with nausea- vomiting has not been well studied. It has been reported that the most commonly used medications for parenteral treatment of vertigo and nausea-vomiting in emergency department are dimenhydrinate (DMT) and metoclopramide (MTP). It has a depressant action on hyper-stimulated labyrinthine function and antiemetic effects, believed to be due to the antihistamine. Dimenhydrinate inhibits vomiting by affecting the histaminic receptor and cholinergic receptor function center of vestibular nucleus in the central vestibular system. Dimenhydrinate reduces the symptoms of vertigo with depressant effects on the labyrinth function by this means.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Nausea, Vomiting, Vertigo
    Keywords
    Metoclopramide, Dimenhydrinate, emergency medicine

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Factorial Assignment
    Masking
    ParticipantCare ProviderInvestigator
    Allocation
    Randomized
    Enrollment
    200 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Dimenhydrinate
    Arm Type
    Active Comparator
    Arm Description
    50 mg Dimenhydrinate with 5 cc syringe in 150 ml normal saline given as a slow intravenous infusion over 15 minutes
    Arm Title
    Metoclopramide
    Arm Type
    Active Comparator
    Arm Description
    10 mg Metoclopramide with 5 cc syringe in 150 ml normal saline given as a slow intravenous infusion over 15 minutes
    Intervention Type
    Drug
    Intervention Name(s)
    Dimenhydrinate
    Other Intervention Name(s)
    Dramamine
    Intervention Description
    50 mg Dramamine with 5 cc syringe in 150 ml normal saline given as a slow intravenous infusion over 15 minutes
    Intervention Type
    Drug
    Intervention Name(s)
    Metoclopramide
    Other Intervention Name(s)
    Primperan, metpamid
    Intervention Description
    10 mg Metoclopramide with 5 cc syringe in 150 ml normal saline given as a slow intravenous infusion over 15 minutes
    Primary Outcome Measure Information:
    Title
    compare the effects of intravenous dimenhydrinate and metoclopramide in the treatment of nausea due to vertigo in emergency setting. (nausea and vertigo scores as measured by Visual Analogue Scale.)
    Description
    - participants will be followed for the duration of hospital stay, an expected average of 30 minutes.
    Time Frame
    Change from Baseline in nausea and vertigo scores at 30 minutes.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: between 18 to 65 years old patients, had vertigo and accompanied nausea or vomiting [VAS (visual analog scale) score >5] during their emergency department episode of care for which the attending physician recommended intravenous antiemetic medication. Exclusion Criteria: abnormal vital signs, women who were pregnant or lactation, those with a history of epilepsy, acute psychiatric symptoms, organic brain disease, parkinson's disease or phaeochromocytoma, or any known allergy to the study drugs, uncooperative individuals, use of any antiemetic drug in the previous 8 hours or previous delivery of intravenous fluids during the emergency department episode of care, currently undergoing chemotherapy or radiotherapy, mechanical obstruction or perforation, gastrointestinal bleeding, inability to understand study explanation or outcome measures (any reason), known allergy or previous adverse reaction to metoclopramide or dimenhydrinate, and patients who refused to participate study.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Bulent ERDUR, proffessor
    Organizational Affiliation
    Pamukkale University
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Learn more about this trial

    Comparison of Efficacy Dimenhydrinate and Metoclopramide in the Treatment of Nausea Due to Vertigo

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