Survey of the analgesic effect of venous Paracetamol in comparison with the combination of venous Paracetamol and Propofol in the relief of acute migraine headache
Determine the amount of pain in intravenous Paracetamol compared to Paracetamol and Propofol in the relief of acute migraine headache
Design
Two arm parallel group randomised trial with blinded postoperative care and blocking randomize method, with 80 patients.
Settings and conduct
This study will be conducted at Khatam al-Anbia hospital in Zahedan. Also, it's a double-blind type of study, which only the doctor responsible for distributing the medicine knows the name of drugs, and patient and the other physician who records the pain score are blinded.
Participants/Inclusion and exclusion criteria
The inclusion criteria are: Failure to receive narcotic drugs or other Triptans like vasoconstrictor, such as Dihydroergotamine, within 24 hours before referral to the emergency department; Patients treated with systemic Corticosteroids; Patients with Diabetes Mellitus history, active gastrointestinal ulcers, myocardial infarction in the last week; Family history of hypocalmic paralysis (for Dexamethasone).
Exclusion criteria are those who have kidney failure.
Intervention groups
Intervention group 1: received 1000 mg paracetamol (A) Intervention group 2: received 500 mg paracetamol and 0.5 mg per kilogram of perpofol (due to combination of paracetamol and propofol, paracetamol dose reduced to 500 mg) (B)
Main outcome variables
Pain score (VAS) will be evaluated from 0 to 10, so that zero equals the absence of pain and 10 equals to be the most conceivable pain for the patient.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180628040274N1
Registration date:2018-08-24, 1397/06/02
Registration timing:registered_while_recruiting
Last update:2018-08-24, 1397/06/02
Update count:0
Registration date
2018-08-24, 1397/06/02
Registrant information
Name
Farahnaz Ahmadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 54 3329 5744
Email address
farahnaz.ahmadi@zaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-08-21, 1397/05/30
Expected recruitment end date
2019-02-18, 1397/11/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Survey of the analgesic effect of venous Paracetamol in comparison with the combination of venous Paracetamol and Propofol in the relief of acute migraine headache
Public title
Comparison of analgesic effect of Paracetamol with combination of Paracetamol and Propofol in the relief of acute migraine headache
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Failure to receive narcotic drugs or other Triptans, such as vasoconstrictor, such as Dihydroergotamine, within 24 hours before referral to the emergency department
Patients treated with systemic Corticosteroids
Patients with Diabetes Mellitus history, active gastrointestinal ulcers, myocardial infarction in the last week
Family history of hypocalmic paralysis (for Dexamethasone)
Exclusion criteria:
Those who have kidney failure
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
The samples are randomly divided into 8 groups in a randomized block and then will divide into 2 groups. Accordingly, based on the probability of placing the patient in a group of 8 in each block, 4 patients in group A and 4 patients in group B Will be accidental. Then, on a visit, a block is selected and will be assigned to the relevant group based on the order of the patient's arrival and the card row in each patient block.
Blinding (investigator's opinion)
Double blinded
Blinding description
This is double-blind clinical trial study, only the The doctor is responsible for distributing the medication knows the name of the drug and the patient and other physician who registers the pain score is not aware of the type of medication taken.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Zahedan University of Medical Sciences
Street address
Zahedan University of Medical Sciences, Dr Hesabi sq., Daneshgah blvd.
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Approval date
2018-05-22, 1397/03/01
Ethics committee reference number
IR.ZAUMS.REC .1397.094
Health conditions studied
1
Description of health condition studied
Acute migraine headache
ICD-10 code
G43
ICD-10 code description
Migraine
Primary outcomes
1
Description
Pain
Timepoint
Pain score is recorded based on the VAS scale before treatment and 5, 10, 20, 30, and 45 minutes after treatment.
Method of measurement
By VAS or Visual Analogue Scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group1: Paracetamol recipients - After giving explanations and obtaining the written consent of individuals to participate in the project, this group will receive 1000 mg Paracetamol.
Category
Treatment - Drugs
2
Description
Intervention group2: Receiving Paracetamol and Propofol combination - After giving explanations and obtaining written consent of individuals to participate in the project, this group will receive 500 mg Paracetamol and 0.5 mg / kg Propofol (due to combination of Paracetamol and Propofol, the dose of Paracetamol is reduced to 500 mg).
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Khatam Al Anbiya Hospital
Full name of responsible person
Zabihollah Hashemzehi
Street address
Khatam Al Anbiya Hospital, Jam-e-jam blvd.
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9815733169
Phone
+98 54 3322 0501
Email
zabih1966@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Mohsen Taheri
Street address
Zahedan University of Medical Sciences, Dr Hesabi sq., Daneshgah blvd.
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Phone
+98 54 3329 5715
Email
taheri@zaums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Zahedan 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
Zahedan University of Medical Sciences
Full name of responsible person
Farahnaz Ahmadi
Position
Resident of Emergency Medicine
Latest degree
Medical doctor
Other areas of specialty/work
Emergency Medicine
Street address
Zahedan University of Medical Sciences, Dr Hesabi sq., Daneshgah blvd.
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Phone
+98 54 3329 5744
Email
farahnaz.ahmadi@zaums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Farahnaz Ahmadi
Position
Resident of Emergency Medicine
Latest degree
Medical doctor
Other areas of specialty/work
Emergency Medicine
Street address
Zahedan University of Medical Sciences, Dr Hesabi sq., Daneshgah blvd.
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Phone
+98 54 3329 5744
Email
farahnaz.ahmadi@zaums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Farahnaz Ahmadi
Position
Resident of Emergency Medicine
Latest degree
Medical doctor
Other areas of specialty/work
Emergency Medicine
Street address
Zahedan University of Medical Sciences, Dr Hesabi sq., Daneshgah blvd.
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Phone
+98 54 3329 5744
Email
farahnaz.ahmadi@zaums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Only part of the information, such as the main outcome information, can be shared.
When the data will become available and for how long
The start of the access period will be 6 months after the publication of the results.
To whom data/document is available
Data will only be available to scholars working in university and academic institutions.
Under which criteria data/document could be used
The data should be used only for the purpose of future studies.
From where data/document is obtainable
Visit the university vice chancellor for research.
What processes are involved for a request to access data/document
The data will be accessible by the university's research director upon confirmation of the application.