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

NCT ID: NCT05586763

Last Updated: 2024-12-16

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-02-01
• Study Completion Date: 2024-12-30

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.

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)

Conditions

Peripheral Vertigo

Keywords

ED; vertigo; metoclopramide; promethazine; Prochlorperazine

Study Design

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

Study Groups

Metoclopramid

IM Metoclopramid 10mg

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: 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.

Promethazine

IM Promethazine 25mg

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: 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.

prochloraperazine

IM prochloraperazine 12.5mg

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: 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.

Interventions

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.

Intervention Type: DRUG

Other Intervention Names

Metoclopramid ( 10mg), IM phenergan (25mg) , IM stemetil( 12.5mg)

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Oman Medical Speciality Board

OTHER_GOV

Sponsor Role: lead

Responsible Party

Asma Salim Abdullah Al Buraiki

Comparison of Efficacy of Metoclopramide , promethazine and prochloroperazine in the treatment of Vertigo.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Asma Al Buraiki, MD

Role: PRINCIPAL_INVESTIGATOR

Oman Medical Speciality Board

Locations

Al Nahdha hospital, AFH and Sohar hospital

Muscat, , Oman

Site Status: RECRUITING

Countries

Oman

Central Contacts

Asma Al Buraiki, MD

Role: CONTACT

Phone: +96896735469

Email: asma.b19@resident.omsb.org

Suad AlBulushi, MD master

Role: CONTACT

Phone: +96899266722

Email: suadbulushi@gmail.com

Facility Contacts

Suad AlBulushi, MD

Role: primary

Kawther Al Rahbi, MD

Role: backup

Other Identifiers

Omsb1993

Identifier Type: -

Identifier Source: org_study_id