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Effectiveness of intravenous Dexamethasone versus Propofol for pain relief in the Migraine headache in the Emergency Department in Imam Reza Hospital, Tabriz University of Medical Science.

Protocol summary

Summary
A prospective double blind randomized clinical trial was performed in Imam Reza teaching hospital in Tabriz-Iran. Ninety patients presenting to ED with Migraine headache were enrolled in two equal groups (I,II). In group I, we used intravenous propofol (10-20 mg every 3 -5 minutes) slowly and in group II, we used dexamethasone (approximately 0.15 mg/kg) slowly. Our inclusion criteria were as follows: A. At least five attacks fulfilling the criteria in B, C, D, and E. B. Attack lasts 4 to 72 hours with or without treatment. C. Headache has at least two of the following characteristics: 1. Unilateral location 2. Pulsating quality 3. Moderate to severe intensity 4. Aggravated by walking up stairs or similar routine physical activity D. During headache, at least one of the following: 1. Nausea or vomiting (or both) 2. Photophobia and phonophobia E. History, physical. and neurologic examination and, if appropriate, diagnostic tests to exclude related organic disease. Our exclusion criteria were as follows: 1-Patients who received narcotic, triptans or other vasoconstrictors like intravenous dihydroergotamine 2- Allergy to eggs or soya Pain explained by patients, based on VAS (Visual Analogue Scale) was recorded at the time of entrance to Emergency medicine Department, and in 5, 10, 20,30 and 45 minutes after injection.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201008122496N4
Registration date: 2010-10-15, 1389/07/23
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2010-10-15, 1389/07/23
Registrant information
Name
Hassan Soleimanpour
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1329 1286
Email address
soleimanpourh@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Research Vice chancellor of Tabriz University of Medical Sciences
Expected recruitment start date
2009-07-23, 1388/05/01
Expected recruitment end date
2010-07-23, 1389/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effectiveness of intravenous Dexamethasone versus Propofol for pain relief in the Migraine headache in the Emergency Department in Imam Reza Hospital, Tabriz University of Medical Science.
Public title
Effectiveness of intravenous Dexamethasone versus Propofol for pain relief in Migraine headache in the Emergency Department in Imam Reza Hospital, Tabriz University of Medical Science.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: A. At least five attacks fulfilling the criteria in B, C, D, and E. B. Attack lasts 4 to 72 hours with or without treatment. C. Headache has at least two of the following characteristics: 1. Unilateral location 2. Pulsating quality 3. Moderate to severe intensity 4. Aggravated by walking up stairs or similar routine physical activity D. During headache, at least one of the following: 1. Nausea or vomiting (or both) 2. Photophobia and phonophobia E. History, physical. and neurologic examination and, if appropriate, diagnostic tests to exclude related organic disease. Exclusion criteria: 1-Patients who received narcotic, triptans or other vasoconstrictors like intravenous dihydroergotamine 2- Allergy to eggs or soya
Age
No age limit
Gender
Both
Phase
1-2
Groups that have been masked
No information
Sample size
Target sample size: 90
Randomization (investigator's opinion)
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
Research Vice chancellor of Tabriz University of Medical Sciences
Street address
Research Vice chancellor of Tabriz University of Medical Sciences ,Tabriz University of Medical Sciences, Daneshgah Street, Tabriz-51664, I.R IRAN
City
Tabriz
Postal code
51664
Approval date
2009-06-04, 1388/03/14
Ethics committee reference number
888

Health conditions studied

1

Description of health condition studied
Migraine headache
ICD-10 code
G43.0
ICD-10 code description
common migraine

Primary outcomes

1

Description
Pain
Timepoint
at 5, 10,20,30 and 45th minutes following intervention
Method of measurement
Visual Analogue Scale

Secondary outcomes

empty

Intervention groups

1

Description
Intravenous Propofol 10-20 mg every 3 -5 minutes
Category
Treatment - Drugs

2

Description
Intravenous Dexamethasone approximately 0.15 mg/kg slowly
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam reza hospital
Full name of responsible person
Dr.Hassan Soleimanpour
Street address
Emergency Medicine Department, Tabriz University of Medical Sciences, Daneshgah Street, Tabriz-51664, I.R IRAN.
City
Tabriz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Research Vice chancellor of Tabriz University of Medical Sciences
Full name of responsible person
Dr. Mir Ali Eteraf Oskouei
Street address
Research Vice chancellor of Tabriz University of Medical Sciences ,Tabriz University of Medical Sciences, Daneshgah Street, Tabriz-51664, I.R IRAN.
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research Vice chancellor of Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Dr.Hassan Soleimanpour
Position
Anesthesiologist/Assistant professor of Anesthesiology, MD
Other areas of specialty/work
Street address
Emergency Medicine Department, Tabriz University of Medical Sciences, Daneshgah Street, Tabriz-51664, I.R IRAN.
City
Tabriz
Postal code
51664
Phone
+98 41 1335 2078
Fax
Email
h_mofid1357@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Hassan Soleimanpour
Position
Anesthesiologist/Assistant professor of Anesthesiology, MD
Other areas of specialty/work
Street address
Emergency Medicine Department, Tabriz University of Medical Sciences, Daneshgah Street, Tabriz-51664, I.R IRAN.
City
Tabriz
Postal code
51664
Phone
+98 41 1335 2078
Fax
Email
h_mofid1357@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr.Hassan Soleimanpour
Position
Anesthesiologist/Assistant professor of Anesthesiology, MD
Other areas of specialty/work
Street address
Emergency Medicine Department, Tabriz University of Medical Sciences, Daneshgah Street, Tabriz-51664, I.R IRAN.
City
Tabriz
Postal code
51664
Phone
+98 41 1335 2078
Fax
Email
h_mofid1357@yahoo.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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