to compare the analgesic effect of intravenous (IV) ketamine with standard migraine treatment in patients admitted to emergency department of Shahid Mohammadi Hospital in Bandar Abbas
Design
This evaluation is a phase 3 clinical trial with a control group with parallel, not blinded and not randomized groups, accordingly, 23 people will be evaluated in each group.
Settings and conduct
After receiving the ethics code from the ethics committee of Hormozgan University of Medical Sciences, the study and its risk and potential complications will be explained for patients after obtaining written consent. Primary ECG will be obtained from all patients, all patients will be under cardiac monitoring and female patients will be evaluated for pregnancy. All patients with a history of heart problems, pregnant women and who will not complete written consent form and not meet the inclusion criteria will be excluded from the study. The allocation of patients in two groups will be based on demographic characteristics and their matching. Based on this, after considering the patients' demographic data, patients will be divided into two equal groups of patients, as intervention and control group.
Participants/Inclusion and exclusion criteria
people between 18-70 years' old who referred to emergency department of Shahid Mohammadi Hospital in 2019 with migraine pain
Intervention groups
A group of patients (standard treatment) will receive first-line treatment including 30 mg IV Ketolol and 10mg IV metoclopramide. The other group will receive IV ketamine 1mg/kg in addition to standard treatment. The prescribed drug will be diluted with 10 ml distilled water for 3 to 5 minutes.
Main outcome variables
Headache intensity
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170224032753N2
Registration date:2020-03-22, 1399/01/03
Registration timing:retrospective
Last update:2020-03-22, 1399/01/03
Update count:0
Registration date
2020-03-22, 1399/01/03
Registrant information
Name
Mohammadjavad Khorasani
Name of organization / entity
Hormozgan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 76 3335 4055
Email address
khorasani@hums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-10-21, 1398/07/29
Expected recruitment end date
2019-11-20, 1398/08/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison the Effect of Intravenous Ketamine with Standard Treatment in Migraine Patients Admitted to Emergency Department
Public title
"Comparison the Effect of Intravenous Ketamine with Standard Treatment in Migraine Patients"
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Known migraine patients ,referring to emergency department of Shahid Mohammadi hospital in Bandarabbas
Age between 18 _ 70 years
Exclusion criteria:
history of cardiac disease
not complete the written consent
oxygen saturation level below 92 percent
systolic blood pressure below 90 or over 180 mmHg
heart rate below 50 or higher than 120 beat per minute
respiratory rate below 10 or higher than 30 per minute
consuming any analgesic 4 hour prior to study
pregnancy or lactation
liver cirrhosis
history of drug reaction with morphine or ketamine or other drugs used in the study
patients who are on dialysis
weight under 45 or more than 115 kg
presence of brain mass, chronic pulmonary disease , history of psychosis , or brain damage
Age
From 18 years old to 70 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
46
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Iran National Comittee for Ethics in Biomedical Research
Street address
International Affairs and Scientific Collaborations, Vice-Chancellery for Education of Hormozgan University of Medical Sciences (HUMS),Jomhuri Eslami Blvd, Bandar Abbas, Iran
City
Bandarabbas
Province
Hormozgan
Postal code
7919915519
Approval date
2019-05-19, 1398/02/29
Ethics committee reference number
IR.HUMS.REC.1398.037
Health conditions studied
1
Description of health condition studied
Migraine headache
ICD-10 code
G43
ICD-10 code description
Migraine
Primary outcomes
1
Description
Headache intensity
Timepoint
Before treatment, 30 , 60 and 90 minutes after treatment
Method of measurement
Visual Analogue Scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: will receive IV ketamine 1mg/kg in addition to standard treatment including 30mg IV Ketorolac and 10mg IV metoclopramide, The designated drug was diluted with 10 ml distilled water for 3 to 5 minutes.
Category
Treatment - Drugs
2
Description
Control group: received first-line standard treatment including 30mg IV Ketolol and 10mg IV metoclopramide.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Mohammadi Hospital
Full name of responsible person
Mohammad Javad Khorasani
Street address
Shahid Mohammadi hospital , jomhoori eslami Blvd.
City
Bandarabbas
Province
Hormozgan
Postal code
7919915519
Phone
+98 76 3334 7000
Email
khorasani@hums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Bandare-abbas University of Medical Sciences
Full name of responsible person
Teimoor Aghamollai
Street address
Vice Chancellery for Research, Payambarazam Hospital , Jomhoorieslami Blvd.
City
Bandarabbas
Province
Hormozgan
Postal code
7919915519
Phone
+98 76 3333 7192
Email
taghamolaei@hums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Bandarabbas University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Bandare-abbas University of Medical Sciences
Full name of responsible person
Mohammad Javad Khorasani
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Emergency Medicine
Street address
Shahid Mohammadi Hospital, Jomhoorieslami Blvd.
City
Bandarabbas
Province
Hormozgan
Postal code
7919915519
Phone
+98 76 3334 7000
Email
khorasani@hums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Bandare-abbas University of Medical Sciences
Full name of responsible person
Mohammad Javad Khorasani
Position
Assiciate professor
Latest degree
Specialist
Other areas of specialty/work
Emergency Medicine
Street address
Shahid Mohammadi Hospital, Jomhoorieslami Blvd.
City
Bandarabbas
Province
Hormozgan
Postal code
7919915519
Phone
+98 76 3334 7000
Email
khorasani@hums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Bandare-abbas University of Medical Sciences
Full name of responsible person
Mohammad Javad Khorasani
Position
Associate profesoor
Latest degree
Specialist
Other areas of specialty/work
Emergency Medicine
Street address
Shahid Mohammadi Hospital, Jomhoorieslami Blvd.
City
Bandarabbas
Province
Hormozgan
Postal code
7919915519
Phone
+98 76 3334 7000
Email
khorasani@hums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
To protect the secrets of patients participating in the project