comparison of the effectiveness of acetaminophen and acetaminophen plus caffeine in treatment of electroconvulsive therapy induced headache in psychiatric patients.
The aim of study is to compare acetaminophen and acetaminophen plus caffeine in treatment of electroconvulsive therapy induced headache.
Design
Randomized, single blinded, parallel clinical trial
Settings and conduct
Data is collected from inpatients and outpatients of Roozbeh hospital of psychiatric diseases in Tehran city. Investigator is blinded as pharmacy staff who put drugs in two groups of packets named A and B while investigator is unaware which packet contains which drug.
Participants/Inclusion and exclusion criteria
Inclusion criteria: age 18 to 65 years old; candidate for electroconvulsive therapy; complain of headache after electroconvulsive therapy session; voluntary agreement to participate in study according to informed consent.
Exclusion criteria: intellectual disability; pregnancy or breast feeding; gastrointestinal ulcer; renal or hepatic injuries
Intervention groups
Acetaminophen group: The investigator interviews with the patient who received electroconvulsive therapy about headache intensity, after recovery. Acetaminophen is administered to patient. Investigator interviews with the patient 30 minutes, 1 hour and 2 hours after drug administration about headache intensity.
Acetaminophen plus caffeine group: The investigator interviews with the patient who received electroconvulsive therapy, after recovery about headache intensity. Acetaminophen caffeine is administered to patient. Investigator interviews with the patient 30 minutes, 1 hour and 2 hours after drug administration about headache intensity.
Main outcome variables
Headache intensity
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170207032435N3
Registration date:2018-07-23, 1397/05/01
Registration timing:registered_while_recruiting
Last update:2018-07-23, 1397/05/01
Update count:0
Registration date
2018-07-23, 1397/05/01
Registrant information
Name
Mahboube Bonyadi
Name of organization / entity
Tehran University of Medical Scienses
Country
Iran (Islamic Republic of)
Phone
+98 21 64120
Email address
m72bonyadi@gmail.com
Recruitment status
Recruitment complete
Funding source
pharmacy faculty, Tehran university of medical sciences, thesis fund
Expected recruitment start date
2017-06-21, 1396/03/31
Expected recruitment end date
2018-09-21, 1397/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
comparison of the effectiveness of acetaminophen and acetaminophen plus caffeine in treatment of electroconvulsive therapy induced headache in psychiatric patients.
Public title
Acetaminophen plus caffeine in electroconvulsive therapy induced headache
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age: 18 to 65 years old
Patients who have been candidate for electroconvulsive therapy by a psychiatrist
Patients who answer yes to the question "Do you have headache?" asked by investigator after the therapeutic session
Signing the voluntary informed consent by patient or his legal guardian
Exclusion criteria:
Intellectual disability
Pregnancy or breast feeding
History of allergic reaction to acetaminophen or caffeine
Active gastrointestinal ulcer
Active renal or hepatic disease, renal or hepatic failure
History of cardiovascular disease, history of hypertension
Age
From 18 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
Investigator
Sample size
Target sample size:
72
Randomization (investigator's opinion)
Randomized
Randomization description
we used block randomization by means of online tool on sealedenvelope.com. we made a sequence of 18 blocks. Every block consists of 2 A characters and 2 B characters.
Blinding (investigator's opinion)
Single blinded
Blinding description
The investigator is blinded. The pills are located in packets named A and B. Investigator does not know which pill is in the packet.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
research.tums.ac.ir
Street address
Pharmacy faculty, Tehran university of medical sciences, 16 Azar street, Enghelab street, Tehran city, Iran
Intervention group: After electroconvulsive therapy session, the investigator asks patient about headache . If patient confirms that he has headache, investigator will explain the pain scale requesting from patient to determine the degree of headache intensity by a number from 1 to 10. Then acetaminophen is randomly administered to the patient. 30 minutes, one hour and two hours after drug administration, investigator interviews patient again about his headache intensity due to pain scale.
Category
Treatment - Drugs
2
Description
Intervention group: After electroconvulsive therapy session, the investigator asks patient about headache . If patient confirms that he has headache, investigator will explain the pain scale requesting from patient to determine the degree of headache intensity by a number from 1 to 10. Then acetaminophen caffeine is randomly administered to the patient. 30 minutes, one hour and two hours after drug administration, investigator interviews patient again about his headache intensity due to pain scale.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Ruzbeh psychiatry hospital
Full name of responsible person
Padide Ghaeli
Street address
رRoozbeh hospital, South Karegar street, Hor square, Enghelab street, Tehra, Iran
City
Tehran
Province
Tehran
Postal code
1333715914
Phone
+98 21 5541 9151
Email
M72bonyadi@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical sciences
Full name of responsible person
Dr Mohammad reza Rouini
Street address
16 Azar street, Enghelab street, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
۱۴۱۷۶۱۴۴۱۱
Phone
+98 21 5541 2756
Email
pharmacy@tums.ac.ir
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
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
Tehran University of Medical Sciences
Full name of responsible person
Padide Ghaeli
Position
clinical pharmacist, professor, full professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
16 Azar Street, Enghelab street, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
۱۴۱۷۶۱۴۴۱۱
Phone
+98 21 6552 1835
Fax
Email
pghaeli63@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Padide Ghaeli
Position
clinical pharmacist, professor, full professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Ruzbeh Hospital, South Karegar street, Tehran, Iran
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
Our data include age and gender of the patients, technical aspects of each therapeutic session ( electrical pulse energy and seizure duration) and headache intensity in determined times.
When the data will become available and for how long
From the end of 2019 to 2021.
To whom data/document is available
Indivisuals who need the data in the field of academic and health researches, health care profesionals and interested students.
Under which criteria data/document could be used
To use in medical decision making by health care professionals, researchers in related fields, limited to people who request data by institution email.