Clinical trial NCT02253524: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Nausea
Vomiting
Vertigo
Keywords: Metoclopramide
Dimenhydrinate
emergency medicine
Lead sponsor: Pamukkale University
Sponsor class: OTHER
First posted: 2014-10-01
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: 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.)
timeFrame: Change from Baseline in nausea and vertigo scores at 30 minutes.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Pamukkale University
name: Bulent ERDUR, proffessor
role: STUDY_DIRECTOR
References: