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CompletedNCT02253524Updated Oct 1, 2014

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

A Phase 4 interventional study of Dimenhydrinate and Metoclopramide in Nausea, Vomiting and Vertigo, sponsored by Pamukkale University. Completed. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2014-10-01.

Sponsored by Pamukkale University · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
200
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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
Read the 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.
02

Conditions studied

  • Nausea
  • Vomiting
  • Vertigo

Keywords

  • Metoclopramide
  • Dimenhydrinate
  • emergency medicine
03

In context

Vertigo

248 studies on the registry are indexed under Vertigo; 39 are open to participants now.

This study's enrollment of 200 is above the median of 57 across 186 interventional studies indexed under Vertigo.

Browse Vertigo studies →

Lead sponsor

Pamukkale University is the lead sponsor of 331 studies on the registry; 61 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Factorial assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
200 participants (actual)

Study arms

  • 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

  • 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

Interventions

  • DrugDimenhydrinate

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

    Also known as: Dramamine

  • DrugMetoclopramide

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

    Also known as: Primperan, metpamid

06

What researchers measure

Primary outcomes

  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.)

    - 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.

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 1, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02253524
Lead sponsor
Pamukkale University
Responsible party
Bulent Erdur (Assoc. Prof., Pamukkale University) — Principal investigator
First posted
Oct 1, 2014
Start date
Nov 2012
Primary completion
May 2013
Completion
May 2013
Last update
Oct 1, 2014

Study contacts

Bulent ERDUR, proffessor
study director · Pamukkale University

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2014. You cannot join it, but the record below documents what was studied.

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