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
About this trial
This is an interventional treatment trial for Nausea focused on measuring Metoclopramide, Dimenhydrinate, emergency medicine
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.
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
NCT ID
NCT02253524
First Posted
September 9, 2014
Last Updated
September 27, 2014
Sponsor
Pamukkale University
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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