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

NCT02253524 | Completed Phase 4 DMC

• 1 other identifier: PAU-1179
• Study Type: interventional
• Target: 200
• Locations: 0 countries
• Sites: N/A

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

Conditions

Nausea; Vomiting; Vertigo

Keywords

Metoclopramide; Dimenhydrinate; emergency medicine

Outcome Measures

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.

  Change from Baseline in nausea and vertigo scores at 30 minutes.

Study Arms (2)

Dimenhydrinate

ACTIVE COMPARATOR

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

Drug: Dimenhydrinate

Metoclopramide

ACTIVE COMPARATOR

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

Drug: Metoclopramide

Interventions

Dimenhydrinate DRUG

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

Dimenhydrinate

Metoclopramide DRUG

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

Metoclopramide

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pamukkale University: lead

MeSH Terms

Conditions

Nausea; Vomiting; Vertigo

Interventions

Dimenhydrinate; Metoclopramide

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Vestibular Diseases; Labyrinth Diseases; Ear Diseases; Otorhinolaryngologic Diseases; Neurologic Manifestations; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Diphenhydramine; Ethylamines; Amines; Organic Chemicals; Benzhydryl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Theophylline; Xanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Drug Combinations; Pharmaceutical Preparations; Benzamides; Amides; para-Aminobenzoates; Aminobenzoates; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Chlorobenzoates; Hydroxybenzoate Ethers; Hydroxybenzoates; Hydroxy Acids; Phenyl Ethers; Phenols

Study Officials

• Bulent ERDUR, proffessor

  Pamukkale University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc. Prof.

Study Record Dates

• First Submitted: September 9, 2014
• First Posted: October 1, 2014
• Study Start: November 1, 2012
• Primary Completion: May 1, 2013
• Study Completion: May 1, 2013
• Last Updated: October 1, 2014

Record last verified: 2014-09