Evaluate the magnesium sulfate, as an adjuvant treatment, in managing acute migraine.
Design
Double-blind clinical trial parallel, Randomized
Settings and conduct
In this randomized clinical trial study, patients with migraine referred to Ahvaz Golestan Hospital emergency department، will be randomly divided into two equal groups using block randomization method, Group A will be received 2 g intravenous infusion(I.V) Magnesium sulfate along with 10 mg metoclopramide. and group B will be received 10 mg metoclopramide and placebo. The pain level will be measured by VAS at baseline, 15, 30 and 45 minutes after intervention
Participants/Inclusion and exclusion criteria
Patients with confirmed migraine diagnosis and pain scores more than 4 were included. While, Those with any history of drug adverse reactions, Pregnancy, and lactation, Renal failure, and allergy to magnesium sulfate or metoclopramide were excluded from the study.
Intervention groups
Patients in group A will receive 2 g intravenous infusion(I.V) Magnesium sulfate along with 10 mg metoclopramide. Patients in group B will receive 10 mg metoclopramide and placebo.
Main outcome variables
Headache pain level
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190504043470N1
Registration date:2019-08-04, 1398/05/13
Registration timing:prospective
Last update:2019-08-04, 1398/05/13
Update count:0
Registration date
2019-08-04, 1398/05/13
Registrant information
Name
Abbas Khosravi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8670 5503
Email address
a-khosravi@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-09-21, 1398/06/30
Expected recruitment end date
2020-03-15, 1398/12/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Metoclopramide and Magnesium sulphate versus metoclopramide alone in managing acute migraine
Public title
Study of the therapeutic effects of magnesium sulfate in patients with acute migraine
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Confirmed diagnosis of migraine
Pain scores more than 4
Exclusion criteria:
History of drug adverse reactions
Pregnancy
Lactation
Renal failure
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization will be performed using block randomization method based on four permutation blocks.
Blinding (investigator's opinion)
Double blinded
Blinding description
The patients know they are participating in a study that is aimed to compare the efficacy and side effects of Metoclopramide and Magnesium sulfate versus metoclopramide and placebo in the management of migraine but they are not informed that they receive which drugs. The physician who evaluates the clinical status of patients and the nurse who injects the drug are not aware of the medication that patients receive
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethical commite of Jundishapur University of Ahvaz
Street address
Golestan
City
Ahvaz
Province
Khouzestan
Postal code
6455134358
Approval date
2017-11-28, 1396/09/07
Ethics committee reference number
IR.AJUMS.REC.1396.1142
Health conditions studied
1
Description of health condition studied
Migraine
ICD-10 code
G43
ICD-10 code description
Migraine
Primary outcomes
1
Description
Headache pain score
Timepoint
0, 15, 30, 45 minutes after treatment
Method of measurement
VAS questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: 2 g intravenous infusion(I.V) Magnesium sulfate along with 10 mg metoclopramide
Category
Treatment - Drugs
2
Description
Intervention group: 10 mg metoclopramide I.V injection and placebo
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Ahvaz Imam Khomeini Hospital
Full name of responsible person
Mojtaba Sasani
Street address
Golestan
City
Ahvaz
Province
Khouzestan
Postal code
6455134358
Phone
+98 21 8670 5503
Email
ali.khosssravi70@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran
Full name of responsible person
Mohammad Badvi
Street address
Golestan
City
Ahvaz
Province
Khouzestan
Postal code
6455134358
Phone
+98 21 8670 5503
Email
ali.khossravi70@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for Research, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran
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
Mojtaba Sasani
Position
Student
Latest degree
Medical doctor
Other areas of specialty/work
Emergency Medicine
Street address
Golestan
City
Ahvaz
Province
Khouzestan
Postal code
6455134358
Phone
+98 21 8670 5503
Fax
Email
ali.khossravi70@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Mojtaba Sasani
Position
Student
Latest degree
Medical doctor
Other areas of specialty/work
Emergency Medicine
Street address
Golestan
City
Ahvaz
Province
Khouzestan
Postal code
6455134358
Phone
+98 21 8670 5503
Fax
Email
ali.khossravi70@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Mojtaba Sasani
Position
Student
Latest degree
Medical doctor
Other areas of specialty/work
Emergency Medicine
Street address
Golestan
City
Ahvaz
Province
Khouzestan
Postal code
6455134358
Phone
+98 21 8670 5503
Fax
Email
ali.khossravi70@yahoo.com
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
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not 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