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

Phase 3

Recruiting

• Conditions: Peripheral Vertigo
• Interventions: Drug: Metoclopramid ( 10mg), IM promethazine (25mg) , IM prochloroperazine( 12.5mg)

• Registration Number: NCT05586763
• Lead Sponsor: Oman Medical Speciality Board

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)

Study Timeline

• Study Start: 2022-02-01
• Study First Submitted: 2022-10-12
• Study First Submitted QC: 2022-10-18
• Study First Posted: 2022-10-19
• Status Verified: 2024-06
• Last Update Submitted: 2024-12-11
• Last Update Posted: 2024-12-16
• Primary Completion: 2024-12-28
• Study Completion: 2024-12-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 90

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Metoclopramid	Metoclopramid ( 10mg), IM promethazine (25mg) , IM prochloroperazine( 12.5mg)	IM Metoclopramid 10mg
Promethazine	Metoclopramid ( 10mg), IM promethazine (25mg) , IM prochloroperazine( 12.5mg)	IM Promethazine 25mg
prochloraperazine	Metoclopramid ( 10mg), IM promethazine (25mg) , IM prochloroperazine( 12.5mg)	IM prochloraperazine 12.5mg

Primary Outcome Measures

Name	Time	Method
medication effectiveness in peripheral vertigo.	1hr	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)

Secondary Outcome Measures

Name	Time	Method
The need of rescue medication/ appearing of side effects.	0-1hr	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.

Trial Locations

Locations (1)

Al Nahdha hospital, AFH and Sohar hospital; 🇴🇲 Muscat, Oman