Comparison of the efficacy of intravenous paracetamol versus intravenous dexamethasone and intravenous morphine for the emergency department treatment of acute migraine headache
Objectives: To compare the analgesic effect of intravenous paracetamol (apotel) with the common therapies such as dexamethasone and morphine.
Design, Setting, conduct and intervention: The study sample will divides into three randomly groups. In the first group after the diagnosis, 1 gram intravenous acetaminophen will be soluted in 100 cc normal saline and will infused. In the second group, morphine with 0.1 mg/kg dosage will be infused. In the third group 8 mg dexamethasone will be infused.
Inclusion criteria:Age between 18 and 60 year old without any history of neurologic disorder with at least one experience of migraine headache and 4 criteria of 12 criteria of Vascular symptoms. Exclusion criteria : pregnancy; history of neurologic disorder; patients without self consent; Body temperature more than 37.7 C; diastolic blood pressure more than 105 mm Hg.
Variables: Pain severity before starting treatment, 10,20,30 and 60 minutes and 24 hours after starting treatment.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201405217327N4
Registration date:2014-09-30, 1393/07/08
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-09-30, 1393/07/08
Registrant information
Name
Samad Shams Vahdati
Name of organization / entity
Tabriz University of Medical Scinces
Country
Iran (Islamic Republic of)
Phone
+98 41 1658 1401
Email address
shams@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Student Research Committee,Tabriz University of Medical Sciences
Expected recruitment start date
2014-06-22, 1393/04/01
Expected recruitment end date
2014-12-22, 1393/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the efficacy of intravenous paracetamol versus intravenous dexamethasone and intravenous morphine for the emergency department treatment of acute migraine headache
Public title
Comparison of the efficacy of intravenous paracetamol versus intravenous dexamethasone and intravenous morphine for the emergency department treatment of acute migraine headache
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria : the patients between 18 and 60 year old without any history of neurologic disorder with at least one experience of migraine headache and 4 criteria of 12 criteria of Vascular symptoms. Exclusion criteria : pregnancy; history of neurologic disorder; patients without self consent; Body temperature more than 37.7 C; diastolic blood pressure more than 105 mm Hg.
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
270
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Subjects will be randomized by Random.com website.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tabriz University of Medical Scinces Ethic Committe
Street address
Central building number 2, Tabriz University of Medical Scinces, Golgasht street, Tabriz
City
Tabriz
Postal code
Approval date
2014-02-05, 1392/11/16
Ethics committee reference number
5/4/9871
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 intensity of the acute migrane head ache
Timepoint
Before treatment, 10 minutes after the begining of treatment, 20 minutes after the begining of the treatment, 30 minutes after the begining of the treatment, 24 hours after the begining of the treatment.
Method of measurement
Visual analoge score, Intensity of the pain in proportion to millimetr from 0 to 100 will be measured.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: 1 gram acetaminophen will be soluted in 100 cc normal saline and will be infused in 10 minutes as a single dose.
Drug name: Apotel, 1 g/6.7ml
Chemical compound: Acetaminophen
Company: Uni Pharma S.A
country: Greece
Category
Treatment - Drugs
2
Description
Control group: Morphine with 0.1 mg/kg dosage will be soluted in 100 cc normal saline and will be infused in 10 minutes as a single dose in order to simulation.
Drug name: Morphin, 10 mg/ml Injection
Chemical compound: Morphine sulfate
company: Darou Pakhsh-Iran
Country: Iran
Category
Treatment - Drugs
3
Description
Control group: 8 milligram dexamethasone will be soluted in 100 cc normal saline and will be infused in 10 minutes as a single dose in order to simulation.
Drug name: Dexamethasone, 8 mg/ml
Chemical compound: Dexamethasone
Company: Raha Co Isfahan-Iran
Country: Iran
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Tabriz Imam Reza Hospital
Full name of responsible person
Dr.Samad Shams Vahdati
Street address
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Student Research Committee
Full name of responsible person
Robab Irani
Street address
Research Development Building, University Street.
City
Tabriz
Grant name
-
Grant code / Reference number
-
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Student Research Committee
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
Tabriz University of Medical Sciences
Full name of responsible person
Dr.Samad Shams Vahdati
Position
Assistant Professor of Emergency Medicine
Other areas of specialty/work
Street address
Emergency Medicine Department,Tabriz Imam Reza Hospital
City
Tabriz
Postal code
Phone
+98 914 115 6941
Fax
Email
Shams@tbzmed.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr.Samad Shams Vahdati
Position
Assistant Professor
Other areas of specialty/work
Street address
Emergency Medicine Department,Tabriz Imam Reza Hospital
City
Tabriz
Postal code
Phone
+98 41 1335 2078
Fax
Email
shams@tbzmed.ac.ir
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)