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

NCT05586763 | Recruiting Phase 3

• 1 other identifier: Omsb1993
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Peripheral Vertigo

Keywords

ED; vertigo; metoclopramide; promethazine; Prochlorperazine

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• The need of rescue medication/ appearing of side effects.

  0-1hr

Study Arms (3)

Metoclopramid

ACTIVE COMPARATOR

IM Metoclopramid 10mg

Drug: Metoclopramid ( 10mg), IM promethazine (25mg) , IM prochloroperazine( 12.5mg)

Promethazine

ACTIVE COMPARATOR

IM Promethazine 25mg

Drug: Metoclopramid ( 10mg), IM promethazine (25mg) , IM prochloroperazine( 12.5mg)

prochloraperazine

ACTIVE COMPARATOR

IM prochloraperazine 12.5mg

Drug: Metoclopramid ( 10mg), IM promethazine (25mg) , IM prochloroperazine( 12.5mg)

Interventions

Metoclopramid ( 10mg), IM promethazine (25mg) , IM prochloroperazine( 12.5mg) DRUG

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.

Also known as: Metoclopramid ( 10mg), IM phenergan (25mg) , IM stemetil( 12.5mg)

Metoclopramid; Promethazine; prochloraperazine

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• □ 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Oman Medical Speciality Board: lead

Study Sites (1)

Al Nahdha hospital, AFH and Sohar hospital

Muscat, 968, Oman

RECRUITING

MeSH Terms

Conditions

Vertigo

Condition Hierarchy (Ancestors)

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

Study Officials

• Asma Al Buraiki, MD

  Oman Medical Speciality Board

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Asma Al Buraiki, MD

CONTACT

+96896735469; asma.b19@resident.omsb.org

Suad AlBulushi, MD master

CONTACT

+96899266722; suadbulushi@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: 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 ) will be done in the pre- medication, post medication 60 mins post intervention 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 in three different positions (supine, sitting and standing). The need for rescue medication ( betahisten or ondansetron ) will be recorded in the paper as well as the need of eply manuver as rescue. Principle investigator in each centers will be responsible to collect the papers for analysis by end of each weeks.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Comparison of Efficacy of Metoclopramide , promethazine and prochloroperazine in the treatment of Vertigo.

Model Details: A 3-arm multi-center, randomized, triple-blind, controlled study comparing three treatments for acute vertigo Arm I : IM Metoclopramid ( 10mg) Arm II : IM Promethazine (25mg) Arm III : IM prochloraperazine( 12.5mg)

Study Record Dates

• First Submitted: October 12, 2022
• First Posted: October 19, 2022
• Study Start: February 1, 2022
• Primary Completion: December 28, 2024
• Study Completion: December 30, 2024
• Last Updated: December 16, 2024

Record last verified: 2024-06

Locations

OM (1)