In order to compare the effect of Propofol with Sumatriptane on acute migraine headache. In a randomized double blinded clinical trial
90 patients aged between 18 and 45 years old who are admitted in emergency department because of acute migraine headache are enrolled in this study. Patients are allocated randomly in the two groups. Exclusion criteria are pregnancy; coronary or peripheral vascular disease; opium addiction and patients taken Ergotamine derivatives in the last 24 hours and patients don,t respond to treatment after one repetition of therapy . After evaluating patients headache by VAS.In Propofol group 2cc of normal saline is injected subcutaneous, 30 to 40 mg Propofol is injected as blouse titrated to sedation score 3 (sleep but arousable with sound) and then 1 to 2cc 1% Propofol injected every 3 to 5 minutes up to maximum 120 mg in20 to 30minuts.In Sumatriptane group 6 mg Sumatriptane is injected sub-cutaneous and then 3cc of normal saline is infused. Then patients re-evaluate by VAS criteria for headache and associated symptoms such as nausea vomiting and side effects of drugs, in 0.5, 1 and 2 hours after therapy.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201008174583N1
Registration date:2012-08-19, 1391/05/29
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2012-08-19, 1391/05/29
Registrant information
Name
Hossein Moshtaghion
Name of organization / entity
Yazd University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 35 1525 0207
Email address
moshtaghion@ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Shahid Sadoughi University of Medical Sciences, Yazd, Iran
Expected recruitment start date
2012-03-19, 1390/12/29
Expected recruitment end date
2012-09-22, 1391/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison the effect of propofol with subcutaneous Sumatriptane in treatment of acute migraine headache
Public title
Comparison the effect of propofol with subcutaneous Sumatriptane in treatment of acute migraine headache
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: all patients aged between 18 and 45 years old with acute migraine headache admitted in emergency department or pain clinic.
exclusion criteria are pregnancy; opium addiction; diastolic pressure greater than 105. Sign and symptoms of organic headache peripheral and coronary artery disease.
Age
From 18 years old to 45 years old
Gender
Both
Phase
N/A
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
Shahid Sadoughi University of Medical Sciences Yazd Iran
Street address
Yazd medical sciences university Bahonar squar Yazd Iran
City
Yazd
Postal code
Approval date
2012-02-27, 1390/12/08
Ethics committee reference number
P/17/1/153935
Health conditions studied
1
Description of health condition studied
Migraine
ICD-10 code
G43.0,G43.
ICD-10 code description
Migraine without aura [common mMigrain)migrane with aura [classical migraine]igraine],
Primary outcomes
1
Description
Headache severity
Timepoint
Before intervention; half an hour; one hour; and 2 hours after intervention
Method of measurement
Visual Analog Scale(VAS)
Secondary outcomes
1
Description
Accompanying symptoms including nausea vomiting photophobia and phonophobia
Timepoint
Before, half an hour, and one hour after intervention
Method of measurement
Observation
2
Description
Drug side effects including hypotension; bradycardia; nausea; vertigo; paresthesia
Timepoint
After intervention
Method of measurement
Observation
Intervention groups
1
Description
In intervention group after starting an IV line 2 cc of normal saline is injected sub-subcutaneously and then 3 cc of Propofol is prescribed as bolus and then 1 to 2 cc of 1% is administered every 3 to 5 minutes up to maximum 120 mg.
Category
Treatment - Drugs
2
Description
In control group after starting an IV line 6 mg of Somatriptane is injected subcutaneously and then 3cc of normal saline is injected as bolus and then 1to 2 cc every 3 to 5 minutes maximally up to 12 cc in 20 to 30 minutes.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Sadoughi Hospital
Full name of responsible person
Seyed Hossein Moshtaghion
Street address
Shahid Sadoughi Hospital, Safaieh
City
Yazd
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Sadoughi University of Medical Sciences-Yazd, Iran
Full name of responsible person
Dr fatemah ezaddini
Street address
Bahonar square, Shahid Sadoughi University of Medical Sciences-Yazd, Iran
City
Yazd
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Sadoughi University of Medical Sciences-Yazd, Iran
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
Shahid Sadoughi University of Medical Sciences-Yazd, Iran
Full name of responsible person
Dr Seyed Hossein Moshtaghion
Position
Asisstant Professor of anesthesiology
Other areas of specialty/work
Street address
Afshar Hospital, Gomhoori Blvd.
City
Yazd
Postal code
Phone
+98 35 1525 0207
Fax
Email
moshtaghion@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Sadoughi University of Medical Sciences-Yazd, Iran
Full name of responsible person
Dr Hossein Moshtaghion
Position
Assistant professor of anesthesiology
Other areas of specialty/work
Street address
Afshar Hospital, Gomhoori Blvd.
City
Yazd
Postal code
Phone
+98 35 1525 0207
Fax
Email
moshtaghion@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shahid Sadoughi University of Medical Sciences, Yazd, Iran
Full name of responsible person
Seyed Hossein Moshatghion
Position
Other areas of specialty/work
Street address
Assistant Professor of Anesthesiology
City
Afshar Hospital, Gomhoory Blvd.
Postal code
Phone
+98 35 1525 0207
Fax
+98 35 1525 0207
Email
moshtaghion@gmail.commoshtaghion@ssu.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)