Investigating the effect of the combination therapy with ketamine and magnesium sulfate on reducing the frequency, duration, severity of attacks and reduction in hospitalizations days due to headache in refractory chronic cluster headache patients
Design
The study will be conducted on 13 patients referred to the hospital who were collected by Convenience method as a non-randomized, non-blinded clinical trial (before after).
Settings and conduct
This study will be conducted in Imam Hossein hospital of Tehran, in a way that the patients will be admitted to the intensive care unit once a week and a combined therapy regiment of ketamine and magnesium sulfate would be administered as: 35 mg iv slowly infused ketamine over two hours along with 3 grams magnesium sulfate IV over 1 hour.
This treatment lasts weekly for 4 weeks.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
definitive diagnosis of chronic cluster headache that was not controlled, despite consuming at least 2 first line oral agent drug .
Exclusion criteria:
Patients with previous sensitivity to ketamine, pregnant or breastfeeding patients, uncontrolled hypertension, arrhythmia,patients with myasthenia gravis
Intervention groups
volunteer patients with refractory chronic cluster headache who will be admitted to the hospital, where initial examinations would be performed and if there are no scientific contraindications, would receive ketamine and magnesium sulfate.
Main outcome variables
changing the intensity, frequency and duration of headache attacks and hospitalization rate due to cluster headache attacks and change in quality of life of patients.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240305061175N1
Registration date:2024-04-04, 1403/01/16
Registration timing:prospective
Last update:2024-04-04, 1403/01/16
Update count:0
Registration date
2024-04-04, 1403/01/16
Registrant information
Name
Kimia Ghanbari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 7343 3000
Email address
ghanbari_kimia@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-04-13, 1403/01/25
Expected recruitment end date
2024-09-05, 1403/06/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of combination therapy with ketamine and magnesium sulfate on refractory chronic cluster headache
Public title
Effect of ketamine and magnesium sulfate in refractory chronic cluster headache
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
بیماران دارای حساسیت قبلی به کتامین
افراد باردار یا در دوران شیردهی
هایپرتنشن غیر کنترل
بلاک قلبی و اریتمی
سابقه heart failureیا coronary artery disease
بیماران با میاستنی گراویس
کم کاری کلیوی شدید
Exclusion criteria:
Age
From 18 years old to 65 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
13
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahid beheshti University of Medical Sciences
Street address
Shahid beheshti university of medical sciences,daneshjoo street,Velenjak,Tehran,Iran
City
Tehran
Province
Tehran
Postal code
1985717443
Approval date
2024-02-26, 1402/12/07
Ethics committee reference number
IR.SBMU.MSP.REC.1402.621
Health conditions studied
1
Description of health condition studied
refractory chronic cluster headache
ICD-10 code
G44.021
ICD-10 code description
Chronic cluster headache, intractable
Primary outcomes
1
Description
Change in the frequency of headache attacks
Timepoint
Patients would be evaluated in two weeks, one month and two months after receiving the treatment protocol.
Method of measurement
Researcher made questionnaire about the frequency of the attacks which is answered by the patient during the survey
2
Description
Change in the headache attack severity
Timepoint
Patients would be evaluated in two weeks, one month and two months after receiving the treatment protocol.
Method of measurement
The universal pain assessment tool(UPAT)
3
Description
Change in the quality of life of patients
Timepoint
Patients would be evaluated in two weeks, one month and two months after receiving the treatment protocol.
Method of measurement
The World Health Organization Quality of Life Brief Version(WHOQOL-BREF)
4
Description
Change in the duration of each headache attack
Timepoint
Patients would be evaluated in two weeks, one month and two months after receiving the treatment protocol.
Method of measurement
Researcher made questionnaire about the frequency of the attacks which is answered by the patient during the survey
5
Description
Change in the frequency of hospitalization due to cluster headache attack.
Timepoint
Patients would be evaluated in two weeks, one month and two months after receiving the treatment protocol.
Method of measurement
Researcher made questionnaire about the frequency of hospitalization due to cluster headache attack which is answered by the patient during the survey
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group:After filling out the personal consent form, the patients with chronic cluster headache resistant to treatment are admitted to the hospital, and before receiving the treatment protocol, basic ECG and echocardiogram are taken from the patients, and preliminary tests are sent to check liver and kidney function. If there are no contraindications, The candidate patient receives the combination of ketamine and magnesium by injection. For the injection of the drug, the patient is admitted to the intensive care unit and is placed under cardiac monitoring. The patient's blood pressure is measured before, during and after receiving the treatment.After receiving the medicine, the patient is monitored in the ICU for six hours, and if there is no problem, the patient is transferred to the ward. They will be admitted to the hospital one day of the week, and during each admission, they will receive 35 mg of slow IV ketamine over two hours along with 3 grams of magnesium sulfate IV over 1 hour. The treatment lasts for four weeks. Finally, after the completion of the treatment period, the intensity, frequency, duration of headache and the quality of life of each patient before and after the intervention in three occasions (two weeks, one month and two months after receiving the invention) will be evaluated by a questionnaire prepared for this purpose.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Hosein hospital of Tehran
Full name of responsible person
Farhad Assarzadegan
Street address
Madani street
City
Tehran
Province
Tehran
Postal code
1617763141
Phone
+98 21 7343 3000
Email
assarzadegan@sbmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Afshin Zarghi
Street address
medical school of shahid beheshti university of medical sciences, daneshjoo st, velenjak, tehran
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 23871
Email
dean.medicalschool@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti 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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Farhad Assarzadegan
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Neurology
Street address
Madani st, imam hossein hospital
City
Tehran
Province
Tehran
Postal code
1617763141
Phone
+98 21 7343 3000
Email
info@sbmu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Farhad Aasarzadegan
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Neurology
Street address
Imam Hosein hospital, Madani street
City
Tehran
Province
Tehran
Postal code
1617763141
Phone
+98 21 7343 3000
Email
assarzadegan@sbmu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Kimia Ghanbari
Position
resident of neurology
Latest degree
Medical doctor
Other areas of specialty/work
Neurology
Street address
Imam Hosein hospital, Madani street
City
Tehran
Province
Tehran
Postal code
1617763141
Phone
+98 21 7343 3000
Email
ghanbari_kimia@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All potential data can be shared after de-identifying individuals.
When the data will become available and for how long
The access period starts 6 months after the results are published.
To whom data/document is available
The data will be available to researchers working in academic and scientific institutions.
Under which criteria data/document could be used
In the case of sending an email request to the corresponding author, the data will be available after the completion of the project.
ِDr Farhad Assarzadegan
assarzadegan@sbmu.ac.ir
From where data/document is obtainable
Email the corresponding author.
What processes are involved for a request to access data/document
After sending the request to the corresponding author, the requested information will be provided.