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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.
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)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Metoclopramid | Active Comparator | IM Metoclopramid 10mg |
|
| Promethazine | Active Comparator | IM Promethazine 25mg |
|
| prochloraperazine | Active Comparator | IM prochloraperazine 12.5mg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 1hr |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 0-1hr |
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Inclusion Criteria:
â–¡ 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 .
Exclusion Criteria:
• Age >60.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Asma Al Buraiki, MD | Contact | +96896735469 | asma.b19@resident.omsb.org | |
| Suad AlBulushi, MD master | Contact | +96899266722 | suadbulushi@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Asma Al Buraiki, MD | Oman Medical Speciality Board | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Al Nahdha hospital, AFH and Sohar hospital | Recruiting | Muscat | 968 | Oman |
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| ID | Term |
|---|---|
| D014717 | Vertigo |
| ID | Term |
|---|---|
| D015837 | Vestibular Diseases |
| D007759 | Labyrinth Diseases |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
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A 3-arm multi-center, randomized, triple-blind, controlled study comparing three treatments for acute vertigo Arm I : IM Metoclopramid ( 10mg) Arm II : IM Promethazine (25mg) Arm III : IM prochloraperazine( 12.5mg)
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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 ) will be done in the pre- medication, post medication 60 mins post intervention 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 in three different positions (supine, sitting and standing). The need for rescue medication ( betahisten or ondansetron ) will be recorded in the paper as well as the need of eply manuver as rescue. Principle investigator in each centers will be responsible to collect the papers for analysis by end of each weeks.
|
|
| D009461 |
| Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |