This study was conducted on migraine patients referred to the emergency department with the aim of examining the effectiveness of acetaminophen and comparing it with the efficacy of ibuprofen in reducing headache. The population studied was migraine patients referred to the Emergency Hospital of Iran's Medical Sciences Hospitals. The sample size is 400 people. This study is a double-blind randomized clinical trial that compares the effectiveness of drugs in two groups of patients with migraine. Patients registered in the first group of painkillers only have 800 mg of ibuprofen and patients in the other group of painkillers are prescribed only an injectable acetaminophen 1000 mg. At the time of referral , the severity of the patient's pain is recorded on the basis of the degree of pain rating , with a score of 0 to 10 , and after two hours, the patient's pain is again scored on the same scale. Also , the number of doses of drugs and side effects Individual records are recorded in each patient's case and the data from the two treatment groups are compared
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017050333787N1
Registration date:2017-10-05, 1396/07/13
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-10-05, 1396/07/13
Registrant information
Name
Mania asgharpour
Name of organization / entity
Azad Islamic University
Country
Iran (Islamic Republic of)
Phone
+98 33418587
Email address
mania.asgharpour@kiau.ac.ir
Recruitment status
Recruitment complete
Funding source
Iran University of Medical Sciences
Expected recruitment start date
2017-03-21, 1396/01/01
Expected recruitment end date
2017-09-20, 1396/06/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of Intravenous Ibuprofen And Intravenous Paracetamol In Reducing Migraine Headaches
Public title
Comparison of Intravenous Ibuprofen And Intravenous Paracetamol In Reducing Migraine Headaches
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Migraine disease; Age range of 16-60 years; Absence of other neurological disorders; Non-addiction.
Exclusion criteria: No neurological disorders; history of active peptic ulcer; pregnant women
Age
From 16 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
400
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
-
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Iran Ethics Committee of the Medical Faculty of Medical Sciences
Street address
Iran University of Medical Science - Hemmat Highway - Tehran -Iran
City
Tehran
Postal code
66666666
Approval date
2017-01-17, 1395/10/28
Ethics committee reference number
IR.IUMS.REC 1395.9311307024
Health conditions studied
1
Description of health condition studied
Migraine
ICD-10 code
G43.0
ICD-10 code description
Migraine without aura [common migraine]
Primary outcomes
1
Description
The pain
Timepoint
Time zero and two hours later
Method of measurement
Visual analogue scale (vas)
Secondary outcomes
1
Description
Including stomach and intestinal ulcers and gastrointestinal bleeding
Timepoint
Two hours later
Method of measurement
Examination
Intervention groups
1
Description
The intervention in the first group was 800 mg Ibuprofen and repeat if needed two hours later
Category
Treatment - Drugs
2
Description
Intervention in the second group with ampoule of َAcetaminophen 1000 mg and repeat if needed two hours later
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Rasoul Akram Hospital /Hafte tir Hospital / Firoozgar Hospital
Full name of responsible person
Dr Hamid Moshgy
Street address
Shahrdari blvd - mehrshahr - karaj
City
Karaj
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr Hamed Basir Ghafoori
Street address
Tehran
City
Tehran
Grant name
------------
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr Hossein Shaker
Position
Assistant / Supervisor
Other areas of specialty/work
Street address
Rasool Akram Hospital - Tehran
City
Tehran
Postal code
666666666
Phone
-
Fax
Email
drhshaker@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr Hamid Moshki
Position
Assistant Resident of Emergency Medicine
Other areas of specialty/work
Street address
Rasool Akram Hospital -Tehran
City
Tehran
Postal code
Phone
+98 26 3341 9204
Fax
Email
moshgy75@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University of Karaj
Full name of responsible person
Dr Mania Asgharpour
Position
Neuroscientist / Assistant Professor
Other areas of specialty/work
Street address
Rajai Shahr in Karaj Islamic Azad University
City
karaj
Postal code
Phone
+98 26 3341 9204
Fax
Email
mania.asgharpour@kiau.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)