1
Clinical Trial Protocol
Iranian Registry of Clinical Trials
05 Nov 2022
Comparison of sumatriptan and propofol VS Sumatriptan and placebo in acute migraine
Protocol summary
Summary
In this double-blinded, randomized trial, we compare the efficacy of combination of subcutaneus Sumatriptan and Propofol VS subcutaneus Sumatriptan and placebo for treatment of acute migraine. A total of 60 cases of acute migraine attack aged between 15 and 45 years admitted to the emergency department will be randomly divided into two treatment groups: (1) 6 mg of Sumatriptan subcutaneously and 30 µg.kg.min of Propofol infused intravenously, (2) 6 mg of Sumatriptan subcutaneously and placebo. Headache severity will be assessed use a visual analog scale before treatment, 0.5 and 1 hour after treatment. Accompanying symptoms, probable side effects will be also assessed. Follow-up was conducted 72 hours later by calling the patients and inquiring about headache recurrence.
General information
Acronym
IRCT registration information
IRCT registration number: IRCT2015050422089N1 Registration date: 2016-01-29, 1394/11/09 Registration timing: retrospective
Last update:
Update count: 0 Registration date
2016-01-29, 1394/11/09 Registrant information
Name
Reza Farahmand Rad
Name of organization / entity
Kermanshah university of Medical Science Country
Iran (Islamic Republic of) Phone
+98 21 2298 9356 Email address
rfarahmandrad@ssu.ac.ir Recruitment status
Recruitment complete Funding source
Vice chancellor for research, Shahid Sadoughi University of Medical Science of Yazd
Expected recruitment start date 2014-09-21, 1393/06/30
Expected recruitment end date 2015-09-21, 1394/06/30 Actual recruitment start date
empty
Actual recruitment end date empty
Trial completion date empty
Scientific title
Comparison of sumatriptan and propofol VS Sumatriptan and placebo in acute migraine
Public title
Comparison of sumatriptan and propofol VS Sumatriptan and placebo in acute migraine
Purpose Treatment
Inclusion/Exclusion criteria
Inclusion criteria: all patient aged 18 to 45 years old with migrain headache Exclusion criteria: Pregnancy,
Hypertension, Previous CVA, propofol sensitivity, Sumatriptan sensitivity, coronary artery disease.
Age
No age limit Gender
Both Phase
Bioequivalence
2 Groups that have been masked
No information Sample size
Target sample size: 60
Randomization (investigator's opinion) Randomized
Randomization description Blinding (investigator's opinion)
Double blinded Blinding description Placebo
Used Assignment
Parallel
Other design features
Secondary Ids
1
Registry name -
Secondary trial Id -
Registration date empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahid Sadoughi University of Medical Science
Street address
Shahid Sadoughi University of Medical Science, Bahonar square, Yazd, Iran
City Yazd Postal code Approval date
2015-02-03, 1393/11/14
Ethics committee reference number 17/1/235385
Health conditions studied
1
Description of health condition studied Migraine
ICD-10 code G43.2-G43.
ICD-10 code description
Migraine without aura (common migraine )
Primary outcomes
1
Description Pain Timepoint
Before intervention, 10-minute iterval after intervention until 1 hour
Method of measurement Visual pain score
Secondary outcomes
1
Description Hypoxia Timepoint
Before intervention, 10- minute interval after intervention until 1 hour
Method of measurement Pulse oximetry
Intervention groups
1
Description
In intervention group after starting IV Line 30
microgram/kg/ Propofol in 100cc normal saline infused for one hour and 6 miligram Sumatriptane injected subcutaneously .
Category
Treatment - Drugs
2
Description
In control group after starting IV line100 cc normal saline as placebo infused for one hour and 6 miligram
Sumatriptane injected subcutaneousely.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center Shahid Sadoughi hospital Full name of responsible person
Dr. Reza Farahmand Rad- Dr. Marzieh Ghilian Street address
Ebne sina street, Shahid ghandi boulevard, Safaieh City
Yazd
2
Recruitment center
Name of recruitment center Shahid Rahnemoon hospital
3 Full name of responsible person
Dr. Reza Farahmand Rad- Dr. Marzieh Ghilian Street address
Farrokhi street, Shahid Rahnemoon hospital City
Yazd
Sponsors / Funding sources
1 Sponsor
Name of organization / entity
Vice chancellor for research, Shahid Sadoughi university of Medical Science Of Yazd
Full name of responsible person Dr. Hushang Mehrparvar Street address
Central department of Shahid Sadoughi university of Medical Science, Bahonar square, 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
Vice chancellor for research, Shahid Sadoughi university of Medical Science Of Yazd
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 Science Full name of responsible person
Dr. Marzieh Ghilian Position
Emergency Medicine Resident Other areas of specialty/work Street address
Emergency Department, Shahid Sadoughi hospital City
Yazd Postal code Phone
+98 358223511 Fax
marziehghilian@yahoo.com / ghilian@ssu.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Sadoughi University of Medical Science Full name of responsible person
Dr. Reza Farahmand Rad Position
Assistant Professor of Emergency Medicine Other areas of specialty/work
Street address
Emergency Department, Shahid Sadoughi hospital City
Yazd Postal code Phone
+98 35 3822 3514 Fax
rfarahmandrad@ssu.ac.irrfarahmandrad@gmail.com Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shahid Sadoughi University of Medical Science Full name of responsible person
Dr. Reza Farahmand Rad Position
Assistant Professor of Emergency Medicine Other areas of specialty/work
Street address
emergency department shahid sadoughi hospital City
yazd Postal code Phone
00 Fax Email
rfarahmandrad@ssu.ac.ir rfarahmandrad@gmail.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
4 empty
