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

Peripheral Vertigo Clinical Trial

— BBPVOMSBAFH  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05586763
• Other study ID #: Omsb1993
• Status: Recruiting
• Phase: Phase 3
• Start date: February 1, 2022
• Est. completion date: August 30, 2023

Study information

• Verified date: October 2022
• Source: Oman Medical Speciality Board
• Contact: Asma Al Buraiki, MD
• Phone: +96896735469
• Email: asma.b19[@]resident.omsb.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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, double-blind, controlled study comparing three treatments for acute vertigo in three medical centers : AlNahdha hospital , Sohar Hospital and AFH hospital. Oman From February 2022 to February 2023.

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 double 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 (18-65) 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)

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: August 30, 2023
• Est. primary completion date: February 28, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Dizziness
• Peripheral Vertigo
• Vertigo

Intervention

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, post medication at 30 and 60 mins posts anti-vertigo medication and at time of disposition. 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.

Locations

Country	Name	City	State
Oman	Al Nahdha hospital, AFH and Sohar hospital	Muscat

Sponsors (1)

Lead Sponsor	Collaborator
Oman Medical Speciality Board

Country where clinical trial is conducted

Oman, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	30 minutes
Secondary	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.	30 minutes/1hour