- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03830398
Comparison of Drugs on Headache Treatment After ECT Treatment
February 2, 2019 updated by: Onur Koyuncu, Mustafa Kemal University
Comparison of Paracetamol and Dexketoprofen Trometamol on Headache Treatment After Electroconvulsive Treatment
Electroconvulsive treatment (ECT) is still actual for treatment of psychiatric symptoms.
Headache is a very common symptom after this application.
The investigators compare the effect of two different drugs for the treatment of headache after ECT.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Detailed Description
Electroconvulsive treatment (ECT) is used as an alternative application instead of drug therapy for psychiatric symptoms.
ECT application is repeated 8-12 times according to the treatment of the patient.
This treatment is done in 2 or 3 days intervals.
The most adverse effects of ECT are headache, memory disorders, myalgia, nausea and vomiting, cardiovascular problems.
The most common seen adverse effect is headache with approximately 60% incidence.
The main drugs used for the treatment of headache related to ECT are NSAIs and paracetamol.
The aim of the current study is to compare the effect of paracetamol and dexketoprofen trometamol on headache treatment after ECT.
Study Type
Interventional
Enrollment (Anticipated)
225
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Cagla Buket Akkurt, Prof
- Phone Number: +905053783204
- Email: caglabuket@gmail.com
Study Locations
-
-
-
Hatay, Turkey, 31000
- Recruiting
- Mustafa Kemal University Medicine Faculty Anesthesiology Department
-
Contact:
- Onur Koyuncu, Assist. Prof
- Phone Number: 5337744757
- Email: onurko@yahoo.com
-
Principal Investigator:
- Onur Koyuncu, Assoc.Prof
-
Sub-Investigator:
- Sedat Hakimoglu, Assoc.Prof
-
Sub-Investigator:
- Senem Urfali, Ast.Prof
-
Sub-Investigator:
- Sumeyra Yesil, M.D.
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 78 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- All patients who were admitted for ECT and gave informed written consent were included in the study.
Exclusion Criteria:
- Exclusion criteria included patients who gave a history of allergy to acetaminophen, lacked capacity to give informed consent and developed complications such as delirium following ECT.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Sequential Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Paracetamol
Parol group: intravenous infusion in 30 min Generic name: Parol Dosage form: intravenous Dosage: 1 gr Frequency: preop one dose only Duration: For one week
|
The investigators apply paracetamol during a week in preoperative room 45 min before ECT
Other Names:
|
Active Comparator: Deksketoprofen trometamol
Sertofen group: intravenous infusion in 30 min Generic name: Sertofen Dosage form: intravenous Dosage: 50 mg Frequency: preop one dose only Duration: For one week
|
The investigators apply paracetamol during a week in preoperative room 45 min before ECT
Other Names:
|
Placebo Comparator: Placebo
Placebo group: intravenous infusion in 30 min Generic name: Serum physiologic Dosage form: intravenous Dosage: 100 ml Frequency: preop one dose only Duration: For one week
|
The investigators apply placebo during a week in preoperative room 45 min before ECT
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Headache (Visual Analogue Scale 0-10)
Time Frame: Postoperative 2. hour, 4. hour, 6. hour (up to six hours after intervention)
|
Headache (VAS) change is being assessed in three different time frames after ECT
|
Postoperative 2. hour, 4. hour, 6. hour (up to six hours after intervention)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Additive analgesic-antiemetic consumption
Time Frame: Postoperative 2. hour, 4. hour, 6. hour (up to six hours after intervention)
|
If VAS ≥ 4, then diclofenac sodium im is given- If nausea-vomiting occurs, ondansetrone 4mg iv is given.The numbers of given drugs will be recorded in each interval.
|
Postoperative 2. hour, 4. hour, 6. hour (up to six hours after intervention)
|
Adverse effects (Nausea-Vomiting, bradycardia, hypotension)
Time Frame: Postoperative 2. hour, 4. hour, 6. hour (up to six hours after intervention)
|
Number of adverse efffects will be recorded in each interval.
|
Postoperative 2. hour, 4. hour, 6. hour (up to six hours after intervention)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Onur Koyuncu, Asc.Prof, Mustafa Kemal Univ.
- Study Chair: Sedat Hakimoglu, Asc.Prof, Mustafa Kemal Univ.
- Study Director: Senem Urfalı, Ast.Prof, Mustafa Kemal Univ.
- Principal Investigator: Sumeyra Yesil, Resident, Mustafa Kemal Univ.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 20, 2018
Primary Completion (Anticipated)
May 1, 2019
Study Completion (Anticipated)
June 1, 2019
Study Registration Dates
First Submitted
January 15, 2019
First Submitted That Met QC Criteria
February 2, 2019
First Posted (Actual)
February 5, 2019
Study Record Updates
Last Update Posted (Actual)
February 5, 2019
Last Update Submitted That Met QC Criteria
February 2, 2019
Last Verified
February 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2018/171
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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