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

Oman Medical Speciality Board

Status and phase: Enrolling; Phase 3

Conditions: Peripheral Vertigo

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

Study type: Interventional

Funder types: Other

Identifiers

NCT05586763

Omsb1993

Details and patient eligibility

About

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.

Full 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)

Enrollment: 90 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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90 participants in 3 patient groups

Metoclopramid

Active Comparator group

Description:

IM Metoclopramid 10mg

Treatment:

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

Promethazine

Active Comparator group

Description:

IM Promethazine 25mg

Treatment:

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

prochloraperazine

Active Comparator group

Description:

IM prochloraperazine 12.5mg

Treatment:

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