RecruitingPhase 3NCT05586763

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


Sponsor

Oman Medical Speciality Board

Enrollment

90 participants

Start Date

Feb 1, 2022

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 YearsMax Age: 60 Years

Inclusion Criteria2

  • □ 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 Criteria11

  • 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.

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Interventions

DRUGMetoclopramid ( 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.


Locations(1)

Al Nahdha hospital, AFH and Sohar hospital

Muscat, Oman

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NCT05586763