Clinical trial NCT05586763: Comparison of Efficacy of Metoclopramide , Promethazine and Prochloroperazine in the Treatment of Vertigo.
Official title: Comparison of Efficacy of Metoclopramide , Promethazine and Prochloroperazine in the Treatment of Vertigo.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Peripheral Vertigo
Keywords: ED
vertigo
metoclopramide
promethazine
Prochlorperazine
Lead sponsor: Oman Medical Speciality Board
Sponsor class: OTHER_GOV
First posted: 2022-10-19
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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)
Primary purpose: TREATMENT

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)

Eligibility criteria: 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.

Primary outcomes:
measure: medication effectiveness in peripheral vertigo.
timeFrame: 1hr
Secondary outcomes:
measure: The need of rescue medication/ appearing of side effects.
timeFrame: 0-1hr
Other outcomes:
Locations:
city: Muscat
country: Oman
facility: Al Nahdha hospital, AFH and Sohar hospital
Study officials:
affiliation: Oman Medical Speciality Board
name: Asma Al Buraiki, MD
role: PRINCIPAL_INVESTIGATOR
References: