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Comparison of the effectiveness of morphine and ketorolac in the treatment of acute migraine attacks in patients referred to emergency department of imam khomeyni hospital of urmia

Protocol summary

Study aim
Determining and comparing the effectiveness of sumatriptan, morphine and ketorolac in the treatment of acute migraine attacks
Design
A double-blind clinical trial that has 3 parallel intervention groups. The method of data randomization is also simple randomization using a random number table (the patient and the researcher will be blind to patient grouping).
Settings and conduct
Patients in the emergency room of Imam Khomeini Hospital will receive Sumatriptan at a dose of 6 mg, Ketorolac at a dose of 30 mg and morphine at a dose of 5 mg. Patients will be monitored while receiving medication with a pulse oximeter. All patients will complete the questionnaire. Patients and researchers are blinded.
Participants/Inclusion and exclusion criteria
Inclusion criteria: age over 18 years, history of migraine more than one year, the experience of 2-10 migraine attacks per month, if the patient is taking a migraine prevention medication, they have not changed it for at least the last three months. Exclusion criteria: Patients who are allergic to the study medications; contraindications to the use of these drugs such as basilar migraine and hemiplegic, cerebrovascular and cardiovascular diseases, uncontrolled blood pressure, taking ergotamine or monoamine oxidase inhibitors, triptans and other serotonin agonists; chronic painful diseases other than migraine, blood dyscrasias, chronic liver, kidney, and lung failure, drug addiction, pregnancy, type 1 and 2 diabetes, lack of recovery and the need to take other medications.
Intervention groups
3 groups, each one will receive one of the drugs sumatriptan, morphine or ketorolac
Main outcome variables
Headache; quality of life

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20210129050168N1
Registration date: 2022-05-30, 1401/03/09
Registration timing: registered_while_recruiting

Last update: 2022-05-30, 1401/03/09
Update count: 0
Registration date
2022-05-30, 1401/03/09
Registrant information
Name
Mostafa chenari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3237 9671
Email address
mostafachenari@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-05-21, 1401/02/31
Expected recruitment end date
2022-08-22, 1401/05/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effectiveness of morphine and ketorolac in the treatment of acute migraine attacks in patients referred to emergency department of imam khomeyni hospital of urmia
Public title
Comparison of the effectiveness of morphine and ketorolac in the treatment of acute migraine attacks
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
being at least 18 years old having a migraine history for at least 1 year having 2 -10 migraine attacks per month if the patient is receiving a prophylactic medication, they shouldn't have changed or interrupted it at least for the previous 3 months
Exclusion criteria:
The patient is allergic to the studied drugs Contraindications to the use of these drugs such as basilar migraine(migraine with brainstem aura) and hemiplegic migraine, cerebrovascular and cardiovascular diseases, uncontrolled hypertension, ergotamine-containing drugs and monoamine oxidase inhibitors Blood dyscrasias Chronic painful diseases other than migraine Chronic hepatic, renal, and pulmonary failure Drug addiction Pregnancy Type 1 and 2 diabetes
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Investigator
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 70
Randomization (investigator's opinion)
Randomized
Randomization description
To randomize the study, the two drugs are filled into syringes marked with codes (a) for ketorolac and (b) for morphine so that the patient and the researcher are blind to the grouping of patients. The patient will be randomly placed in one of these two groups and will receive the drug and the questionnaires will be filled out while the patient and the researcher do not know about the prescribed medication.
Blinding (investigator's opinion)
Double blinded
Blinding description
Participants in the project, adviser and researcher will be blind to the drug used during treatment.But the doctor will be aware of the drug. The drugs will be filled in similar syringes and in 2 boxes (a) and (b) Only the relevant doctor will be aware of. After the drug injection,the questionnaires will be filled while the patient and the researcher do not know the type of medicine.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Urmia university of medical sciences
Street address
Resalat
City
Urmia
Province
East Azarbaijan
Postal code
5714783734
Approval date
2020-09-15, 1399/06/25
Ethics committee reference number
IR.UMSU.REC.1399.210

Health conditions studied

1

Description of health condition studied
acute migraine attack
ICD-10 code
G43
ICD-10 code description
Migraine

Primary outcomes

1

Description
The effect of medication on reducing pain intensity based on visual analog scale (VAS) questionnaire
Timepoint
0 minutes- 60 minutes -120 minutes
Method of measurement
Ten-point VAS questionnaire based on pain intensity

Secondary outcomes

1

Description
effects of headache on a person's quality of life and daily activities, and a score above 50 is nominated as a candidate for migraine.
Timepoint
0 minutes- 60 minutes -120 minutes
Method of measurement
A standard questionnaire to assess demographic characteristics and headache, including disability (test [HIT] -6)

Intervention groups

1

Description
Intervention group: Ketorolac will be injected intravenously as a single 30 mg dose
Category
Treatment - Drugs

2

Description
Intervention group: morphine will be injected intravenously as a single 5 mg dose
Category
Treatment - Drugs

3

Description
Intervention group: Sumatriptan will be injected subcutaneously and in a single dose of 6 mg
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Emergency department of Imam Khomeyni hospital of Urmia
Full name of responsible person
Hamidreza Mehryar
Street address
Ershad
City
Urmia
Province
West Azarbaijan
Postal code
8135157157
Phone
+98 44 3346 9931
Email
imamkhomeynihospital@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Hamdollah Sharifi
Street address
Nazloo
City
Urmia
Province
West Azarbaijan
Postal code
5714783734
Phone
+98 44 3223 4897
Email
urmiaunivercityofmedicalscience@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Oroumia University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Other

Person responsible for general inquiries

Contact
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Mostafa Chenari
Position
Student
Latest degree
Medical doctor
Other areas of specialty/work
Medical Pharmacy
Street address
Sarbazshahid
City
Tabriz
Province
East Azarbaijan
Postal code
5143749491
Phone
+98 935 967 2989
Email
mostafachenari@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Hamdollah Sharifi
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
General Practitioner
Street address
Urmia
City
Urmia
Province
West Azarbaijan
Postal code
5756115327
Phone
+98 44 4992 3275
Email
sharifi_md1992@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Mostafa Chenari
Position
Student
Latest degree
Medical doctor
Other areas of specialty/work
Medical Pharmacy
Street address
Sarbazshahid
City
Tabriz
Province
East Azarbaijan
Postal code
5143749491
Phone
+98 935 967 2989
Email
mostafachenari@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
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
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