The comparison of intravenous ketorolac and intravenous metoclopramide analgesic effect in patients with acute migraine headache referring to emergency department.
Main purpose: Comparison of intravenous ketorolac and intravenous metoclopramide analgesic effect in patients with acute migraine headache referring to the emergency department during years 2016-2017, Inclusion criteria: Age older than 15 and younger than 70 years; History of migraine headache with or without aura, Exclusion criteria: Age younger than 15 or older than 70 years; Pregnant women; People with stomach ulcers; Renal failure; Liver failure; 100 patients with acute migraine headache are inroled. Ketorolac and metoclopramide are injected intravenously in each group. We use VAS to determine the severity of headache and nausea and vomiting at times, a moment before the injection, 30 minutes, 60 minutes, 2 hours, 4 hours and 24 hours after the injection in both intravenous ketorolac and metoclopramide groups and using closed questions to determine the severity of vertigo in patients in a moment before the injection, 1 hour and 2 hours after injection in both intravenous ketorolac and metoclopramide groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016010425854N1
Registration date:2016-08-21, 1395/05/31
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-08-21, 1395/05/31
Registrant information
Name
Arsalan Tahmasbi
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 61 3224 7507
Email address
tahmasbi.a@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Ahvaz Jundishapur University of Medical Sciences.
Expected recruitment start date
2016-06-21, 1395/04/01
Expected recruitment end date
2017-03-19, 1395/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The comparison of intravenous ketorolac and intravenous metoclopramide analgesic effect in patients with acute migraine headache referring to emergency department.
Public title
Ketorolac and metoclopramide in acute migraine headache.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Age older than 15 and younger than 70 years; History of migraine headache with or without aura. Exclusion criteria: Age younger than 15 or older than 70 years; Duration of headache less than 4 or over 72 hours; Patients who had undergone lumbar puncturation(LP) since last 48 hours; Patients who had a systemic headache; Body temperature more than 38 degrees of Celsius; Neurologic deficit; Allergy or tolerance to drugs of study; Participated in other study; Pregnant women; If the patient within 12 hours before entering to the center, received analgesic drug; Patients who for any reason are used analgesics on a daily basis; Patients who can not communicate verbally; If the patient's lost the consciousness due to alcohol consumption and or other material is gone; People with stomach ulcers and severe digestive problems (especially chronic diarrhea); Renal failure; Liver failure; Patients who suffer simultaneously from headaches other than migraine such as tension headaches or sinusitis; If the patient is receiving anticoagulant (due to drug interactions with ketorolac); If the patient is taking probenecid (due to increasing half-life of ketorolac); If the patient receiving phenothiazines, lithium or anti epileptic drugs (due to drug interactions with metoclopramide ); If the patient prior to entering the study have akathisia.
Age
From 15 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ahvaz Jundishapur University of Medical Sciences
Street address
Golestan highway, Ahvaz, Khouzestan, Iran
City
Ahvaz
Postal code
6135715794
Approval date
2016-02-20, 1394/12/01
Ethics committee reference number
IR.AJUMS.Rec.1394.488
Health conditions studied
1
Description of health condition studied
Acute migraine headache
ICD-10 code
G43
ICD-10 code description
Migraine
Primary outcomes
1
Description
Severity of headache
Timepoint
A moment before the injection, 30 minutes, 60 minutes, 2 hours, 4 hours and 24 hours after the injection.
Method of measurement
Visual analoge scale
2
Description
24 hours following up.
Timepoint
24 hours after the injection
Method of measurement
After 24 hours, patients are called and asked them to say the severity of their headache as this follow; severe, moderate, mild headache and without headache.
Secondary outcomes
1
Description
Severity of vertigo( as a side effect of study medication)
Timepoint
A moment before injection, 1 hours and 2 hours after injection.
Method of measurement
Without vertigo, Mild to moderate vertigo but able to do activities, Sever vertigo and inability to do activities.
Intervention groups
1
Description
Ketorolac 30 mg intravenous.
Category
Treatment - Drugs
2
Description
Metoclopramide 20 mg intravenous.
Category
Treatment - Drugs
3
Description
Biperidine 5 mg intravenous for prevention of metoclopramide side effects.
Category
Prevention
4
Description
Aquapura 5 cc as placebo of biperidine.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Emergency department of Golestan hospital in Ahvaz
Full name of responsible person
Dr Javad Mozaffari - Assistant professor of emergency medicine
Street address
Emergency medicine office, Emergency department of Goletan hospital
City
Ahvaz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Student research committee, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran.
Full name of responsible person
Dr Nader Saki
Street address
Room 16, floor, Student Research Committee, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran
City
Ahvaz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Student research committee, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, 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
Ahvaz Jundishapur University of Medical Sciences.
Full name of responsible person
Arslan Tahmasbi
Position
Medicine intern.
Other areas of specialty/work
Street address
482, 3 Asli, Hasirabad.
City
Ahvaz
Postal code
6175767135
Phone
+98 61 3224 7507
Fax
Email
tahmasbi.a@ajums.ac.irarsalan.tahmasbi@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Emergency department, Golestan hospital in Ahvaz.
Full name of responsible person
Dr Javad Mozaffari
Position
Assistant professor of emergency medicine.
Other areas of specialty/work
Street address
Emergency medicine office, Golestan hospital in Ahvaz
City
Ahvaz
Postal code
Phone
+98 61 3222 5763
Fax
Email
mozafari.taha@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences.
Full name of responsible person
Arsalan Tahmasbi
Position
Medical student
Other areas of specialty/work
Street address
Golestan highway, Ahvaz Jundishapur University of Medical Sciences, Medical college.
City
Ahvaz
Postal code
Phone
+98 61 3333 7681
Fax
Email
tahmasbi.a@ajums.ac.irarsalan.tahmasbi@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)