Comparison of Efficacy of Metoclopramide , Promethazine and Prochloroperazine in the Treatment of Vertigo. (BBPVOMSBAFH)

Background: Vertigo as acute symptom seem to be one of most common presentation in ED, can be treated in ED with multiple medication . Objective: This study aimed to compare the therapeutic efficacy of metoclopramide, promethazine and prochloroperazine in patients presenting with signs and symptoms suggestive of acute peripheral vertigo to the ED . Methods: A 3-arm multi-center, randomized, triple-blind, controlled study comparing three treatments for acute vertigo in three medical centers : AlNahdha hospital Oman , Sohar Hospital Oman and AFH hospital Oman. Oman From February 2022 to August 2024.

Study Overview

• Status: Recruiting
• Conditions: Peripheral Vertigo
• Intervention / Treatment: Drug: Metoclopramid ( 10mg), IM promethazine (25mg) , IM prochloroperazine( 12.5mg)

Detailed Description

• Background Vertigo is one of most ED visit symptoms, It can be due to central or peripheral cause. The most frequent three reasons for vertigo are acute peripheral vestibulopathy (vestibular neuritis, labyrinthitis), Meniere's disease, and benign paroxysmal positional vertigo (BPPV). Usually ED doctors started with Epley maneuver for relief of symptoms and then started with medication.
• Objective:

This study aimed to compare the therapeutic efficacy of metoclopramide, promethazine and prochloroperazine in patients presenting with signs and symptoms suggestive of acute peripheral vertigo to the ED .

• Research methods: This will be done by assessing the Best medication can be used to treat peripheral vertigo with least side effect through Randomized triple blinded analysis will use 3 medications. All medications will be saved in similar syringe with white paper cover and labeled as A,B, C .The treating EM Doctor will prescribe medication as anti-vertigo then one of covered medication will be randomly taken among 3 medication groups. Target population will be all patient in age group (18-60) years visiting the emergency department at Al Nahdha hospital, AFH and Sohar hospital who complain of peripheral vertigo after assessment and excluding central cause. Ethical approval will be applied for through the OMSB (Ministry of health ethical committee)

• Study Type: Interventional
• Enrollment (Estimated): 90
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Asma Al Buraiki, MD; Phone Number: +96896735469; Email: asma.b19@resident.omsb.org
• Study Contact Backup: Name: Suad AlBulushi, MD master; Phone Number: +96899266722; Email: suadbulushi@gmail.com

Study Locations

• Oman
  • Muscat, Oman, 968
    • Recruiting
    • Al Nahdha hospital, AFH and Sohar hospital
    • Contact: Suad AlBulushi, MD; Phone Number: +96899266722; Email: suadbulushi@gmail.com
    • Contact: Kawther Al Rahbi, MD; Phone Number: +96899822278; Email: Alrahbi79@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• □ Acute peripheral vertigo with nausea or vomiting (vas, visual analog scale >5) during their emergency department episode of care for which the attending physician recommending antiemetic, onset with in 3 days .

  • Age( 18- 60).

Exclusion Criteria:

• • Age >60.

  • Any organic brain disease (Clear central cause; "malignancy with brain metastasis".)
  • History of epilepsy
  • Pregnancy.
  • Dementia, Parkinson's disease
  • Abnormal vital signs
  • Any known drug allergy to the study drugs
  • Undergoing chemotherapy or radiotherapy
  • Mechanical bowel obstruction or perforation, gastrointestinal bleeding
  • Inability to understand study explanation or outcome measures (any reason)
  • Patients who refused to participate study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Metoclopramid; IM Metoclopramid 10mg	Drug: Metoclopramid ( 10mg), IM promethazine (25mg) , IM prochloroperazine( 12.5mg); Each patient with vertigo symptoms will be registered in vertigo list after written consent taken. The ED doctor will take one paper from the vertigo list box and will write the case there including patient ID, date, age and symptoms. Assessment (VAS & EEV) will be done in the pre- medication 0 min, and at 60 mins posts anti-vertigo medication. The medication will be provided blindly through the pharmacy. Any possible medication side effect and any possible further work up done for patient will be involved in each paper as ED doctor will put a tick near each point. Score will be written in papers as per patient evaluation of their symptoms grade from 1-10. The need for rescue medication ( betahisten or ondansetron ) will be recorded in the paper or is need eply manuver. Principle investigator in each centre will be responsible to collect the papers for analysis by end of each weeks.; Other Names: Metoclopramid ( 10mg), IM phenergan (25mg) , IM stemetil( 12.5mg)
Active Comparator: Promethazine; IM Promethazine 25mg	Drug: Metoclopramid ( 10mg), IM promethazine (25mg) , IM prochloroperazine( 12.5mg); Each patient with vertigo symptoms will be registered in vertigo list after written consent taken. The ED doctor will take one paper from the vertigo list box and will write the case there including patient ID, date, age and symptoms. Assessment (VAS & EEV) will be done in the pre- medication 0 min, and at 60 mins posts anti-vertigo medication. The medication will be provided blindly through the pharmacy. Any possible medication side effect and any possible further work up done for patient will be involved in each paper as ED doctor will put a tick near each point. Score will be written in papers as per patient evaluation of their symptoms grade from 1-10. The need for rescue medication ( betahisten or ondansetron ) will be recorded in the paper or is need eply manuver. Principle investigator in each centre will be responsible to collect the papers for analysis by end of each weeks.; Other Names: Metoclopramid ( 10mg), IM phenergan (25mg) , IM stemetil( 12.5mg)
Active Comparator: prochloraperazine; IM prochloraperazine 12.5mg	Drug: Metoclopramid ( 10mg), IM promethazine (25mg) , IM prochloroperazine( 12.5mg); Each patient with vertigo symptoms will be registered in vertigo list after written consent taken. The ED doctor will take one paper from the vertigo list box and will write the case there including patient ID, date, age and symptoms. Assessment (VAS & EEV) will be done in the pre- medication 0 min, and at 60 mins posts anti-vertigo medication. The medication will be provided blindly through the pharmacy. Any possible medication side effect and any possible further work up done for patient will be involved in each paper as ED doctor will put a tick near each point. Score will be written in papers as per patient evaluation of their symptoms grade from 1-10. The need for rescue medication ( betahisten or ondansetron ) will be recorded in the paper or is need eply manuver. Principle investigator in each centre will be responsible to collect the papers for analysis by end of each weeks.; Other Names: Metoclopramid ( 10mg), IM phenergan (25mg) , IM stemetil( 12.5mg)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
medication effectiveness in peripheral vertigo.	1. Compare the effects of IM metoclopramide or IM promethazine or IM prochloroperazine in three randomizing groups in the treatment of peripheral Vertigo in emergency setting using Visual Analogue Scale taken from visual vertigo analogue scale/adapted from Longridge et al.,2002. (Nausea and vertigo scores as measured by Visual Analogue Scale that include patient assessmet of his symptoms in view of vertigo/ nausea/ vomiting)	1hr

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The need of rescue medication/ appearing of side effects.	The need for more rescue medications to relive the symptoms or for any appearing side effect at the time frame of assessment for vertigo symptom/ side effects like extrapyramidal side effect.	0-1hr

Collaborators and Investigators

• Sponsor: Oman Medical Speciality Board
• Investigators: Principal Investigator: Asma Al Buraiki, MD, Oman Medical Speciality Board

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2022
• Primary Completion (Estimated): December 28, 2024
• Study Completion (Estimated): December 30, 2024

Study Registration Dates

• First Submitted: October 12, 2022
• First Submitted That Met QC Criteria: October 18, 2022
• First Posted (Actual): October 19, 2022

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 11, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Keywords: vertigo; ED; metoclopramide; promethazine; Prochlorperazine
• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Ear Diseases; Labyrinth Diseases; Vestibular Diseases; Vertigo; Dizziness; Sleep Aids, Pharmaceutical; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Antiemetics; Autonomic Agents; Peripheral Nervous System Agents; Gastrointestinal Agents; Dermatologic Agents; Anesthetics, Local; Anesthetics; Central Nervous System Depressants; Sensory System Agents; Histamine Antagonists; Histamine Agents; Neurotransmitter Agents; Hypnotics and Sedatives; Dopamine Agents; Anti-Allergic Agents; Antipruritics; Dopamine Antagonists; Histamine H1 Antagonists; Dopamine D2 Receptor Antagonists; Diphenhydramine; Promethazine; Metoclopramide
• Other Study ID Numbers: Omsb1993

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No