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IRCT20170207032435N3 IRCT 2018-07-23 Tehran University of Medical sciences Acetaminophen plus caffeine in electroconvulsive therapy induced headache comparison of the effectiveness of acetaminophen and acetaminophen plus caffeine in treatment of electroconvulsive therapy induced headache in psychiatric patients. 2017-06-21 anticipated 72 Complete https://irct.ir/trial/25270 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, 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 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. 3 Headache. Intervention 1: 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. Intervention 2: 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. Yes - There is a plan to make this available What will be shared: 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: From the end of 2019 to 2021. To whom: Indivisuals who need the data in the field of academic and health researches, health care profesionals and interested students. Conditions: To use in medical decision making by health care professionals, researchers in related fields, limited to people who request data by institution email. Where to obtain: Email Mahboube Bonyadi: m72bonyadi@gmail.com Padide Ghaeli: pghaeli63@gmail.com How to obtain: 2 to 4 weeks after request delivery Comments:
public Padide Ghaeli
16 Azar Street, Enghelab street, Tehran, Iran
Tehran Iran (Islamic Republic of) ۱۴۱۷۶۱۴۴۱۱ +98 21 6552 1835 pghaeli63@gmail.com Tehran University of Medical Sciences scientific Padide Ghaeli
Ruzbeh Hospital, South Karegar street, Tehran, Iran
Tehran Iran (Islamic Republic of) ۱۴۱۷۶۱۴۴۱۱ +98 21 6552 1835 pghaeli63@gmail.com Tehran University of Medical Sciences Iran (Islamic Republic of) 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 18 years 65 years Both 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 G44.1 Vascular headache, not elsewhere classified Treatment - Drugs Treatment - Drugs 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. 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. Headache intensity. Timepoint: 30 mins, 1 hour & 2 hour after ECT therapy session. Method of measurement: Visual analogue scale. Tehran University of Medical sciences Approved 2017-08-07 research.tums.ac.ir Pharmacy faculty, Tehran university of medical sciences, 16 Azar street, Enghelab street, Tehran city, Iran Tehran Tehran Iran (Islamic Republic of)