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

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-60
SponsorOman Medical Speciality Board

About this trial

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

This trial accepts healthy volunteers

Qualifiers

□ 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).

Disqualifiers

• Age >60.

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

History of epilepsy

Pregnancy.

Trial design

Design model

Parallel

Treatments tested in this trial

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

    Drug

    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.

Treatment groups

90 Participants
are divided into 3 treatment groups
Group A: MetoclopramidActive comparator 1 intervention
Group B: PromethazineActive comparator 1 intervention
Group C: prochloraperazineActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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)

Time frame
1hr

Secondary outcomes

1

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.

Time frame
0-1hr

Other outcomes

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