Comparison of Efficacy of Metoclopramide , Promethazine and Prochloroperazine in the Treatment of Vertigo. (BBPVOMSBAFH)
Primary Purpose
Peripheral Vertigo
Status
Recruiting
Phase
Phase 3
Locations
Oman
Study Type
Interventional
Intervention
Metoclopramid ( 10mg), IM promethazine (25mg) , IM prochloroperazine( 12.5mg)
Sponsored by
About this trial
This is an interventional treatment trial for Peripheral Vertigo focused on measuring ED, vertigo, metoclopramide, promethazine, Prochlorperazine
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.
Sites / Locations
- Al Nahdha hospital, AFH and Sohar hospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Active Comparator
Arm Label
Metoclopramid
Promethazine
prochloraperazine
Arm Description
IM Metoclopramid 10mg
IM Promethazine 25mg
IM prochloraperazine 12.5mg
Outcomes
Primary Outcome Measures
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)
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT05586763
First Posted
October 12, 2022
Last Updated
October 18, 2022
Sponsor
Oman Medical Speciality Board
1. Study Identification
Unique Protocol Identification Number
NCT05586763
Brief Title
Comparison of Efficacy of Metoclopramide , Promethazine and Prochloroperazine in the Treatment of Vertigo.
Acronym
BBPVOMSBAFH
Official Title
Comparison of Efficacy of Metoclopramide , Promethazine and Prochloroperazine in the Treatment of Vertigo.
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
February 1, 2022 (Actual)
Primary Completion Date
February 28, 2023 (Anticipated)
Study Completion Date
August 30, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Oman Medical Speciality Board
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
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, double-blind, controlled study comparing three treatments for acute vertigo in three medical centers : AlNahdha hospital , Sohar Hospital and AFH hospital. Oman From February 2022 to February 2023.
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 double 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 (18-65) 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)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peripheral Vertigo
Keywords
ED, vertigo, metoclopramide, promethazine, Prochlorperazine
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
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)
Masking
ParticipantCare ProviderOutcomes Assessor
Masking Description
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, post medication at 30 and 60 mins posts anti-vertigo medication and at time of disposition. 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.
Allocation
Randomized
Enrollment
90 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Metoclopramid
Arm Type
Active Comparator
Arm Description
IM Metoclopramid 10mg
Arm Title
Promethazine
Arm Type
Active Comparator
Arm Description
IM Promethazine 25mg
Arm Title
prochloraperazine
Arm Type
Active Comparator
Arm Description
IM prochloraperazine 12.5mg
Intervention Type
Drug
Intervention Name(s)
Metoclopramid ( 10mg), IM promethazine (25mg) , IM prochloroperazine( 12.5mg)
Other Intervention Name(s)
Metoclopramid ( 10mg), IM phenergan (25mg) , IM stemetil( 12.5mg)
Intervention Description
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, post medication at 30 and 60 mins posts anti-vertigo medication and at time of disposition. 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.
Primary Outcome Measure Information:
Title
medication effectiveness in peripheral vertigo.
Description
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
30 minutes
Secondary Outcome Measure Information:
Title
The need of rescue medication/ appearing of side effects.
Description
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
30 minutes/1hour
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Asma Al Buraiki, MD
Phone
+96896735469
Email
asma.b19@resident.omsb.org
First Name & Middle Initial & Last Name or Official Title & Degree
Suad AlBulushi, MD master
Phone
+96899266722
Email
suadbulushi@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Asma Al Buraiki, MD
Organizational Affiliation
Oman Medical Speciality Board
Official's Role
Principal Investigator
Facility Information:
Facility Name
Al Nahdha hospital, AFH and Sohar hospital
City
Muscat
ZIP/Postal Code
968
Country
Oman
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Suad AlBulushi, MD
Phone
+96899266722
Email
suadbulushi@gmail.com
First Name & Middle Initial & Last Name & Degree
Kawther Al Rahbi, MD
Phone
+96899822278
Email
Alrahbi79@gmail.com
12. IPD Sharing Statement
Learn more about this trial
Comparison of Efficacy of Metoclopramide , Promethazine and Prochloroperazine in the Treatment of Vertigo.
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