IRCT | Investigating the effect of magnesium sulfate along with a 3-drug regimen (keturolac, plazil and dexamethasone) on the control of acute migraine attacks .

Protocol summary

Study aim: Investigating the effect of magnesium sulfate along with 3-drug regimen (keturolac, plazil and dexamethasone) on controlling acute migraine attacks
Design: This randomized clinical trial study is conducted in a double-blind manner (participants and researchers are not aware of the type of drug prescribed). The method of assigning the intervention to patients is randomly and by the method of randomized permutation blocks with random block sizes of 4, 6 and 8 (using the table related to random permutations)
Settings and conduct: This study will be conducted in Golestan and Razi Hospital, Ahvaz in 1403. which is a randomized and double-blind study on the effect of intravenous Ketorlac and Plazil and intravenous dexamethasone and intravenous Ketorlak and Plazil and dexamethasone with intravenous magnesium sulfate on pain reduction.
Participants/Inclusion and exclusion criteria: Inclusion criteria include patients with migraine headaches aged 18 to 60 who referred to the emergency room. Exclusion criteria: 1. History of sensitivity or allergy to study drugs, 2. Presence of chronic kidney diseases, 3. Patients using painkillers before entering the study, 4. Severe cardiovascular diseases , 5. Electrolytic and metabolic disorders.
Intervention groups: The group receiving intravenous magnesium sulfate along with Ketorlac and Plazil and intravenous Dexamethasone and the group receiving Ketorlac and Plazil and intravenous Dexamethasone
Main outcome variables: pain

General information

Reason for update
Acronym
IRCT registration information: IRCT registration number: IRCT20240930063211N1

Registration date: 2024-10-24, 1403/08/03

Registration timing: registered_while_recruiting

Last update: 2024-10-24, 1403/08/03

Update count: 0
Registration date: 2024-10-24, 1403/08/03

Registrant information: Name

Shayan Beik

Name of organization / entity

Country

Iran (Islamic Republic of)

Phone

+98 930 889 8239

Email address

dr.shayanbeik@gmail.com

Recruitment status: Recruitment complete
Funding source

Expected recruitment start date: 2024-09-29, 1403/07/08
Expected recruitment end date: 2025-03-19, 1403/12/29
Actual recruitment start date: empty
Actual recruitment end date: empty
Trial completion date: empty

Scientific title: Investigating the effect of magnesium sulfate along with a 3-drug regimen (keturolac, plazil and dexamethasone) on the control of acute migraine attacks .

Public title: Investigating the effect of magnesium sulfate on the control of acute migraine attacks
Purpose: Treatment
Inclusion/Exclusion criteria: Inclusion criteria:

Patients with migraine headaches have a pain score greater than 5 (based on visual analog scale (VAS)). The age of the patients should be between 18 and 60 years Consciousness level equal to 15

Exclusion criteria:

Pregnancy or suspected pregnancy History of alcoholism, sensitivity to morphine or painkillers History of mental illness and depression and recent use of sedatives or antipsychotics and use of calcium channel blockers History of cardiac, kidney, liver and metabolic disease The patient's unwillingness to participate in the study
Age: From 18 years old to 60 years old
Gender: Both

Phase

2-3

Groups that have been masked

Participant
Care provider

Sample size

Target sample size: 124

Randomization (investigator's opinion)

Randomized

Randomization description

In this study, in order to assign patients to 2 intervention and control groups, the block randomization method is used (the size of each block is 4 patients, the total blocks are 31). In order to generate a random sequence, Epi info software is used. In this study, the hidden direction Sequencing is done using sealed envelopes and allocations are kept hidden until the last moment

Blinding (investigator's opinion)

Double blinded

Blinding description

Due to the double-blindness of the study, throughout the study, the patients, doctors, and nurses who administered the drugs were unaware of all the steps of the research, and the preparation and injection of the drugs was done by two nurses or residents, so that the person preparing the drug was different from the receiving patient. The drug and the injecting nurse were unaware of the type of drug. All drug injection syringes are uniform and randomization and data recording was done by one person (emergency medicine assistant).

Placebo

Used

Assignment

Parallel

Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee: Name of ethics committee

Ethics committee of Ahvaz University of Medical Sciences

Street address

Informatics Department,First Floor,Research and Technology Vice-Chancellor,Ahvaz University City

City

Ahvaz

Province

Khouzestan

Postal code

15794-61357
Approval date: 2024-09-29, 1403/07/08
Ethics committee reference number: IR.AJUMS.REC.1403.325

Health conditions studied

1

Description of health condition studied: Migraine
ICD-10 code: G43.0
ICD-10 code description: Migraine without aura

Primary outcomes

1

Description: patients with a history of migraine headaches whose pain score was greater than 5 based on the analog visual scale
Timepoint: On arrival, 1 hour and 2 hours after administration of the drug
Method of measurement: visual analog scale (VAS)

Secondary outcomes

1

Description: Measuring the scale of Pain Healing in Patients
Timepoint: On arrival, 1 hour and 2 hours after administration of the drug
Method of measurement: Hemodynamic disorder is assessed by measuring systolic and diastolic blood pressure using a digital sphygmomanometer, and heart rate using a pulse oximeter or heart monitoring.

Intervention groups

1

Description: Intervention group: 3-drug regimen plus magnesium sulfate (30 mg of ketorolac, 10 mg of plazil and 8 mg of Dexamethasone plus 2 grams of magnesium sulfate 50% in a volume of 100 cc
Category: Treatment - Drugs

2

Description: Control group: 3-drug regimen (30 mg of ketorolac, 10 mg of Plazil and 8 mg of dexamethasone
Category: Treatment - Drugs

Recruitment centers

1

Recruitment center: Name of recruitment center

Golestan Hospital,Ahwaz city

Full name of responsible person

Ali Wafaq Nematullahi

Street address

Golestan Hospital,Golestan town,Ahwaz city

City

Ahwaz

Province

Khouzestan

Postal code

33117-61357

Phone

+98 61 3320 4501

Email

golestan-hospital@ajums.ac.ir

1

Sponsor: Name of organization / entity

Ahvaz University of Medical Sciences

Full name of responsible person

Mehrnoosh Zakerkish

Street address

ground floor,Research and Technology, Jundishapur University of Medical Sciences and Healthcare Services, Ahvaz Academic City - Vice-Chancellor for,ahvaz

City

ahwaz

Province

Khouzestan

Postal code

61357-15794

Phone

+98 61 3373 8383

Email

itc@ajums.ac.ir
Grant name: Jundishapur University of Medical Sciences, Ahvaz
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?: Yes
Title of funding source: Ahvaz University of Medical Sciences
Proportion provided by this source: 100
Public or private sector: Public
Domestic or foreign origin: Domestic
Category of foreign source of funding: empty
Country of origin
Type of organization providing the funding: Academic

Person responsible for general inquiries

Contact: Name of organization / entity

Ahvaz University of Medical Sciences

Full name of responsible person

Ali Wafaq Nematullahi

Position

Associate Professor

Latest degree

Specialist

Other areas of specialty/work

Emergency Medicine

Street address

Kianpars ,Ahvaz

City

Ahwaz

Province

Khouzestan

Postal code

۶۱۹۳۶۷۳۱۶۶

Phone

0613394810

Email

vefagh.a@ajums.ac.ir

Person responsible for scientific inquiries

Contact: Name of organization / entity

Ahvaz University of Medical Sciences

Full name of responsible person

Ali Wafaq Nematullahi

Position

Associate Professor

Latest degree

Specialist

Other areas of specialty/work

Emergency Medicine

Street address

Kianpars,Ahwaz

City

Ahwaz

Province

Khouzestan

Postal code

۶۱۹۳۶۷۳۱۶۶

Phone

0613394810

Email

vefagh.a@ajums.ac.ir

Person responsible for updating data

Contact: Name of organization / entity

Ahvaz University of Medical Sciences

Full name of responsible person

Ali Wafaq Nematullahi

Position

Associate professor

Latest degree

Specialist

Other areas of specialty/work

Emergency Medicine

Street address

No.13,west,Kianpars town,Ahvaz city

City

Ahwaz

Province

Khouzestan

Postal code

۶۱۹۳۶۷۳۱۶۶

Phone

+98 917 804 2600

Email

vefagh.a@ajums.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD): No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD: There is no further information
Study Protocol: Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan: Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form: Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report: Undecided - It is not yet known if there will be a plan to make this available
Analytic Code: Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary: Undecided - It is not yet known if there will be a plan to make this available

Investigating the effect of magnesium sulfate along with a 3-drug regimen (keturolac, plazil and dexamethasone) on the control of acute migraine attacks .