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

Last updated: December 11, 2024
Sponsor: Oman Medical Speciality Board
Overall Status: Active - Recruiting

Phase

3

Condition

Low Blood Pressure (Hypotension)

Dizzy/fainting Spells

Treatment

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

Clinical Study ID

NCT05586763
Omsb1993
  • Ages 18-60
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

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 physicianrecommending antiemetic, onset with in 3 days .

  • Age( 18- 60).

Exclusion

Exclusion Criteria:

  • • Age >60.

  • Any organic brain disease (Clear central cause; "malignancy with brainmetastasis".)

  • 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 Design

Total Participants: 90
Treatment Group(s): 1
Primary Treatment: Metoclopramid ( 10mg), IM promethazine (25mg) , IM prochloroperazine( 12.5mg)
Phase: 3
Study Start date:
February 01, 2022
Estimated Completion Date:
December 30, 2024

Study 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)

Connect with a study center

  • Al Nahdha hospital, AFH and Sohar hospital

    Muscat, 968
    Oman

    Active - Recruiting

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