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

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ClinicalTrials.gov Identifier: NCT02253524
Recruitment Status : Completed
First Posted : October 1, 2014
Last Update Posted : October 1, 2014
Sponsor:
Information provided by (Responsible Party):
Bulent Erdur, Pamukkale University

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

Condition or disease Intervention/treatment Phase
Nausea Vomiting Vertigo Drug: Dimenhydrinate Drug: Metoclopramide Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Comparison of Efficacy Dimenhydrinate and Metoclopramide in the Treatment of Nausea Due to Vertigo
Study Start Date : November 2012
Actual Primary Completion Date : May 2013
Actual Study Completion Date : May 2013

Resource links provided by the National Library of Medicine


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 Name: 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




Primary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02253524


Sponsors and Collaborators
Pamukkale University
Investigators
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Study Director: Bulent ERDUR, proffessor Pamukkale University

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Responsible Party: Bulent Erdur, Assoc. Prof., Pamukkale University
ClinicalTrials.gov Identifier: NCT02253524     History of Changes
Other Study ID Numbers: PAU-1179
First Posted: October 1, 2014    Key Record Dates
Last Update Posted: October 1, 2014
Last Verified: September 2014
Keywords provided by Bulent Erdur, Pamukkale University:
Metoclopramide
Dimenhydrinate
emergency medicine
Additional relevant MeSH terms:
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Vestibular Diseases
Dopamine Agents
Vertigo
Nausea
Vomiting
Dizziness
Signs and Symptoms, Digestive
Signs and Symptoms
Labyrinth Diseases
Ear Diseases
Otorhinolaryngologic Diseases
Neurologic Manifestations
Nervous System Diseases
Sensation Disorders
Metoclopramide
Dimenhydrinate
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Dopamine D2 Receptor Antagonists
Dopamine Antagonists
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents