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

September 27, 2014 updated by: Bulent Erdur, Pamukkale University
  • 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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

200

Phase

  • Phase 4

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

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

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: Factorial Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Dimenhydrinate
50 mg Dimenhydrinate with 5 cc syringe in 150 ml normal saline given as a slow intravenous infusion over 15 minutes
Drug: Dimenhydrinate
50 mg Dramamine with 5 cc syringe in 150 ml normal saline given as a slow intravenous infusion over 15 minutes
Other Names:
  • Dramamine
Active Comparator: Metoclopramide
10 mg Metoclopramide with 5 cc syringe in 150 ml normal saline given as a slow intravenous infusion over 15 minutes
Drug: Metoclopramide
10 mg Metoclopramide with 5 cc syringe in 150 ml normal saline given as a slow intravenous infusion over 15 minutes
Other Names:
  • Primperan
  • metpamid

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.)
Time Frame: Change from Baseline in nausea and vertigo scores at 30 minutes.
- participants will be followed for the duration of hospital stay, an expected average of 30 minutes.
Change from Baseline in nausea and vertigo scores at 30 minutes.

Collaborators and Investigators

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

Sponsor

Pamukkale University

Investigators

  • Study Director: Bulent ERDUR, proffessor, Pamukkale University

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

November 1, 2012

Primary Completion (Actual)

May 1, 2013

Study Completion (Actual)

May 1, 2013

Study Registration Dates

First Submitted

September 9, 2014

First Submitted That Met QC Criteria

September 27, 2014

First Posted (Estimate)

October 1, 2014

Study Record Updates

Last Update Posted (Estimate)

October 1, 2014

Last Update Submitted That Met QC Criteria

September 27, 2014

Last Verified

September 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PAU-1179

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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