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

NCT ID: NCT02253524

Last Updated: 2014-10-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-11-30
• Study Completion Date: 2013-05-31

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.

Conditions

Nausea; Vomiting; Vertigo

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Dimenhydrinate

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

Group Type: ACTIVE_COMPARATOR

Dimenhydrinate

Intervention Type: DRUG

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

Group Type: ACTIVE_COMPARATOR

Metoclopramide

Intervention Type: DRUG

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

Interventions

Dimenhydrinate

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

Intervention Type: DRUG

Metoclopramide

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

Intervention Type: DRUG

Other Intervention Names

Dramamine; Primperan; metpamid

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Pamukkale University

OTHER

Sponsor Role: lead

Responsible Party

Bulent Erdur

Assoc. Prof.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Bulent ERDUR, proffessor

Role: STUDY_DIRECTOR

Pamukkale University

Other Identifiers

PAU-1179

Identifier Type: -

Identifier Source: org_study_id