The aim of this study is comparison between metoclopramide and acetaminophen on migraine, tension and cluster headache. All 15 – 75 years patients with migraine, tension and cluster headache will be enrolled in this study. All patients with allergy to metoclopramide and acetaminophen will be excluded. The sample size will be 100 patients. The Patients will be divided randomly in 2 groups. First, headache severity will be measured based on 10 numerical visual analogue scales (VAS). In intervention group 10 mg IV metoclopramide will be injected and in control group 10 mg IV acetaminophen will be injected. Then headache severity will be measured after 15 and 30 minute. Treatment effect will be measured in all 2 groups. After that the effect of 2 drugs on reducing severity of headache and possible side effect will be compared.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014081817812N3
Registration date:2014-09-16, 1393/06/25
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-09-16, 1393/06/25
Registrant information
Name
Gholamreza Faridaalaee
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3382 9540
Email address
faridaalaee@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Urmia University of Medical Sciences
Expected recruitment start date
2014-07-23, 1393/05/01
Expected recruitment end date
2014-09-23, 1393/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of Metoclopramide and intravenous acetaminophen on headache
Public title
Comparison of the effect of Metoclopramide and intravenous acetaminophen on headache in patients that presenting to the Emergency Department of Imam Khomeini hospital of Urmia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: all 15 -75 years patients with migrane, tension and cluster headache will be enrolled in this study.
exclusion criteria: allrgy to acetaminophen and metoclopramide
Age
From 15 years old to 75 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Urmia University of Medical Sciences
Street address
Urmia University of Medical Sciences; Resalat Avenue
City
Urmia
Postal code
Approval date
2014-06-24, 1393/04/03
Ethics committee reference number
umsu.rec.1393.104
Health conditions studied
1
Description of health condition studied
headache
ICD-10 code
G43
ICD-10 code description
Migraine
2
Description of health condition studied
headache
ICD-10 code
G44.0
ICD-10 code description
Cluster headache syndrome
3
Description of health condition studied
headache
ICD-10 code
G44.2
ICD-10 code description
Tension type headache
Primary outcomes
1
Description
reduce in headache severity
Timepoint
Q/15 minute up to 120 minute
Method of measurement
10 numerical visual analogue scales (VAS)
Secondary outcomes
empty
Intervention groups
1
Description
In intervention group 10 mg IV metoclopramide will be administered
Category
Treatment - Drugs
2
Description
In control group 10 mg IV acetaminophen will be infused in 10 minute.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini Hospital
Full name of responsible person
Gholamreza Faridaalaee
Street address
Ershad Avenue
City
Urmia
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Urmia University of Medical Sciences -
Full name of responsible person
Iraj Mohebbi
Street address
Urmia University of Medical Sciences; Resalat Avenue
City
Urmia
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Urmia 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
Urmia University of Medical Sciences
Full name of responsible person
Gholamreza Faridaalaee
Position
Assistant Professor
Other areas of specialty/work
Street address
Imam Khomeini Hospital, Ershad Avenue
City
Urmia
Postal code
Phone
+98 44 3346 9931
Fax
Email
grf.aalae@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Urmia University of Medical Sciences
Full name of responsible person
Gholamreza Faridaalaee
Position
Assistant professor
Other areas of specialty/work
Street address
Imam Khomeini Hospital, Ershad Avenue
City
Urmia
Postal code
Phone
+98 44 3346 9931
Fax
Email
grf.aalae@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Urmia University of Medical Sciences
Full name of responsible person
Gholamreza Faridaalaee
Position
Assistant professor
Other areas of specialty/work
Street address
Urmia Imam Khomeini Hospital, Ershad Avenue
City
Urmia
Postal code
Phone
+98 44 3345 9538
Fax
Email
grf.aalae@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)