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

Nausea Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02253524
• Other study ID #: PAU-1179
• Status: Completed
• Phase: Phase 4
• First received: September 9, 2014
• Last updated: September 27, 2014
• Start date: November 2012
• Est. completion date: May 2013

Study information

• Verified date: September 2014
• Source: Pamukkale University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Turkey: Drug and Medical Device InstitutionTurkey: Ethics Committee
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: May 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dizziness
• Nausea
• Vertigo
• Vomiting

Intervention

Drug:
• Dimenhydrinate
50 mg Dramamine with 5 cc syringe in 150 ml normal saline given as a slow intravenous infusion over 15 minutes
• Metoclopramide
10 mg Metoclopramide with 5 cc syringe in 150 ml normal saline given as a slow intravenous infusion over 15 minutes

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Pamukkale University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Change from Baseline in nausea and vertigo scores at 30 minutes.	No