This is a double blinded randomized trial performed on patients with migraine headache presenting to Sina and Rasool Akram emergency departments. The samples were selected from patients with known migraine headaches who fulfilled the inclusion criteria. Patients without previous history of migraine headache or those in whom the diagnosis was not certain were excluded. Granicetrone was used 2 mg intravenously and it's effects was compared with that of 10 mg intravenous metoclopramide. These drugs were stored in syranges with A and B tags and the patients randomly recieved one of the two drugs based on random block design. Only the chief investigator knows which patient recieved which drug and the rest of investigators were blinded. Pateints were divided into two groups: A, B. Group A recieved 2 mg granicetrone and group B 10 mg metoclopramide. Pain intensity and vomiting episodes were recorded before and 1, 2, 4 hours after drug administration in questionnairs. Patients were examined carefully by investigator and any adverse effect was recorded. Accuracy of this study is 5% with 95% confidence interval and sample size is 150. P value less than 0.05 is considered statistically significant.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201112038292N1
Registration date:2013-01-31, 1391/11/12
Registration timing:retrospective
Last update:
Update count:0
Registration date
2013-01-31, 1391/11/12
Registrant information
Name
Hasan Amiri
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 2235 5477
Email address
h-amiri@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2011-03-21, 1390/01/01
Expected recruitment end date
2012-09-20, 1391/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A Comparision of Granisetron and Metoclopramide in the treatment of nausea and vomiting in patients with migraine headache
Public title
A Comparison of Granisetron and Metoclopramide in the treatment of nausea and vomiting in patients with migraine headache
Purpose
Treatment
Inclusion/Exclusion criteria
inclusion criteria: Patients older than 18 presenting with migraine headache to sina and rasool akram emergency; Have a previous history of migraine headache which was diagnosed by a neurologist; Not being pregnant; No breast feeding; No history of psychiatric disorder in the patient or first degree relatives
exclusion criteria: Patient's incoopration; Headache's charectristics is different from previus attacks; Sudden oncet headache; Abnormal neurologic exam; uncertainity in diagnosis; Head trauma in the previous month
Age
From 18 years old to 100 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
150
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
Ethics Committee of Tehran University of Medical Sciences
Street address
Ghods building, Ghods and Keshavars crossroad
City
Tehran
Postal code
Approval date
2012-10-11, 1391/07/20
Ethics committee reference number
1601/130/د/91
Health conditions studied
1
Description of health condition studied
migraine headache
ICD-10 code
G43
ICD-10 code description
Migraine
Primary outcomes
1
Description
Number of nausea and vomiting episodes
Timepoint
Before, 1, 2, 4 hours after intervention
Method of measurement
Standard Questionnaire
Secondary outcomes
1
Description
Headache intensity
Timepoint
Before, 1, 2, 4 hours after intervention
Method of measurement
Verbal numerical rating scale
2
Description
Adverse effects
Timepoint
Before, 1, 2, 4 hours after intervention
Method of measurement
Standard Questionnaire
Intervention groups
1
Description
In case group the patients received 2 mg granicetrone single dose intravenously
Category
Treatment - Drugs
2
Description
In control group the patients received 10 mg metoclopramide single dose intravenously
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Sina hospital
Full name of responsible person
Dr. Mehrnaz Nikuyeh MD
Street address
Imam Khomeini avenue
City
Tehran
2
Recruitment center
Name of recruitment center
Rasool Akram hospital
Full name of responsible person
Dr. Mehrnaz Nikuyeh MD
Street address
Niayesh Street, Satarkhan Avenue
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Akbar Fotuhi
Street address
Tehran University of Medical Science, Enghelab Avenue
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran university of medical sciences
Full name of responsible person
Dr. Hasan amiri MD
Position
Associated professor
Other areas of specialty/work
Street address
Imam Khomeini avenue, Sina hospital
City
Tehran
Postal code
Phone
+98 21 63120
Fax
Email
h_amiri@sina.tums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran university of medical science
Full name of responsible person
Dr. Hasan amiri MD
Position
Associated professor
Other areas of specialty/work
Street address
Imam Khomeini avenue, Sina hospital
City
Tehran
Postal code
Phone
+98 21 63120
Fax
Email
h_amiri@sina.tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tehran university of medical sciences
Full name of responsible person
Dr. Mehrnaz Nikuyeh
Position
Emergency medicine resident
Other areas of specialty/work
Street address
2, 5th Sarvestan street, Hakimieh
City
Tehran
Postal code
9183644473
Phone
+98 21 7730 1718
Fax
Email
shirin01358@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)