Comparison of the effect of intravenous paracetamol (Apotel) and dexamethasone in the relief of acute migraine headaches referred to the emergency department
Comparison of the effect of intravenous paracetamol and intravenous dexamethasone in the relief of acute migraine headaches referred to the emergency department of Razi Hospital Birjand in 2024
Design
Clinical clinical trial, one blind, randomized and on 80 patients in two groups.
Settings and conduct
Patients in the emergency room are randomly divided into 2 groups. One group receives 1 gram of intravenous paracetamol and the other group receives 8 mg of intravenous dexamethasone.
Participants/Inclusion and exclusion criteria
Patients aged between 18 and 60 years without a history of specific neurological disease who have experienced a migraine headache at least once. No history of continuous use of narcotics and long-term painkillers.
Conditions for exclusion from the study: pregnancy, history of neurological disease, patients without personal consent, having a body temperature higher than 37.7 degrees Celsius, having a diastolic blood pressure higher than 105 mm Hg, patients being treated with systemic corticosteroids, allergy to dexamethasone, eggs Be careful, patients with a history of diabetes mellitus, active gastrointestinal ulcers, myocardial infarction in the previous week and hypokalemic familial paralysis (for dexamethasone). Continuous use of narcotics and long-term painkillers.
Intervention groups
Intervention group A:receiving interavenous paracetmol with a dose 1 gram.
Intervention group B:receiving interavenous dexametasone with dose 8 Mg.
Main outcome variables
Determining the amount of response to pain in two groups; determining and comparing the time after injection until relief; comparing the frequency of complications in the two groups; estimating the duration of hospitalization in the emergency room after injecting drugs; estimating the level of satisfaction with pain reduction
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240619062184N1
Registration date:2024-07-11, 1403/04/21
Registration timing:prospective
Last update:2024-07-11, 1403/04/21
Update count:0
Registration date
2024-07-11, 1403/04/21
Registrant information
Name
Hashem Mirbolooki
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 56 3162 6000
Email address
hashemmirbolooki@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-07-22, 1403/05/01
Expected recruitment end date
2024-10-22, 1403/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of intravenous paracetamol (Apotel) and dexamethasone in the relief of acute migraine headaches referred to the emergency department
Public title
Comparison of the effect of intravenous paracetamol (Apotel) and dexamethasone in the relief of acute migraine headaches
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Not having a specific neurological disease
No history of continuous use of drugs and long-term painkillers
Exclusion criteria:
pregnancy
History of neurological disease
Patients without personal consent
Having a body temperature higher than37.7 degrees Celsius
Having a diastolic blood pressure greater than 105 mm Hg
Patients treated with systemic corticosteroids
Allergy to dexamethasone, egg and soy
Patients with a history of diabetes mellitus
Active gastrointestinal ulcers
Myocardial infarction in the previous week
Hypokalemic familial paralysis (for dexamethasone)
Continuous use of drugs and long-term painkillers
Age
From 18 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
The classification of patients and the type of drug used for the people involved in the research were blinded, and the researcher evaluating the patients was not aware of the drug group prescribed for the patients during the study. For this purpose, all the syringes of both groups have the same appearance and volume with the frequency of use coordinated in both groups. Also, other common treatment measures are implemented for both groups. Therefore, the study will be conducted in a double-blind manner.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Birjand University of Medical Sciences
Street address
Ghaffari Ave,Central Organization of Birjand University of Medical Sciences
City
Birjand
Province
South Khorasan
Postal code
۹۷۱۷۸۵۳۰۷۶
Approval date
2024-06-19, 1403/03/30
Ethics committee reference number
IR.BUMS.REC.1403.098
Health conditions studied
1
Description of health condition studied
Acute migraine headache
ICD-10 code
G44.0
ICD-10 code description
Cluster headache syndrome, unspecified
Primary outcomes
1
Description
Pain reduction in acute migraine headache patients based on Visual pain measurement criteria
Timepoint
When the patient enters the study
Method of measurement
Visual pain measurement criteria
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group A: receiving interavenous paracetamol with a dose 1 gram .The length of the study period is one year and each drug is injected once.
Category
Treatment - Drugs
2
Description
Intervention group B :receiving intravenous dexametasone with a dose 8 Mg.The length of the study period is one year and each drug is injected once.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Birjand;Razi hospital
Full name of responsible person
Hashem Mirbolooki
Street address
Ghaffari Ave
City
Birjand
Province
South Khorasan
Postal code
9717853111
Phone
+98 56 3162 6000
Fax
+98 56 3162 6363
Email
razihospital@bums.ac.ir
Web page address
https://razi.bums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Masood Yousefi
Street address
Ghaffari Ave
City
Birjand
Province
South Khorasan
Postal code
9717853577
Phone
+98 56 3238 1200
Fax
+98 56 3238 1220
Email
research@bums.ac.ir
Web page address
https://rsh.bums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Birjand 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
Birjand University of Medical Sciences
Full name of responsible person
Hashem Mirbolooki
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
Emergency Medicine
Street address
Ghaffari ave ,Razi hospital
City
Birjand
Province
South Khorasan
Postal code
9771990018
Phone
+98 56 3162 6000
Fax
+98 56 3162 6363
Email
hashemmirbolooki@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Hashem Mirbolooki
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
Emergency Medicine
Street address
Ghaffari ave ,Razi hospital
City
Birjand
Province
South Khorasan
Postal code
9771990018
Phone
+98 56 3162 6000
Fax
+98 56 3162 6363
Email
hashemmirbolooki@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Hashem Mirbolooki
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
Ghaffari ave ,Razi hospital
City
Birjand
Province
South Khorasan
Postal code
9771990018
Phone
+98 56 3162 6000
Fax
+98 56 3162 6363
Email
hashemmirbolooki@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
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available