Comparison of Efficacy of Metoclopramide , Promethazine and Prochloroperazine in the Treatment of Vertigo.
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- medication effectiveness in peripheral vertigo.
研究概览
简要总结
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.
详细描述
- 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)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •□ 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).
排除标准
- •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.
研究组 & 干预措施
Metoclopramid
IM Metoclopramid 10mg
干预措施: Metoclopramid ( 10mg), IM promethazine (25mg) , IM prochloroperazine( 12.5mg) (Drug)
Promethazine
IM Promethazine 25mg
干预措施: Metoclopramid ( 10mg), IM promethazine (25mg) , IM prochloroperazine( 12.5mg) (Drug)
prochloraperazine
IM prochloraperazine 12.5mg
干预措施: Metoclopramid ( 10mg), IM promethazine (25mg) , IM prochloroperazine( 12.5mg) (Drug)
结局指标
主要结局
medication effectiveness in peripheral vertigo.
时间窗: 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)
次要结局
- The need of rescue medication/ appearing of side effects.(0-1hr)
研究者
Asma Salim Abdullah Al Buraiki
Comparison of Efficacy of Metoclopramide , promethazine and prochloroperazine in the treatment of Vertigo.
Oman Medical Speciality Board