Comparison of Drugs on Headache Treatment After ECT Treatment
NCT ID: NCT03830398
Last Updated: 2019-02-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
225 participants
INTERVENTIONAL
2018-11-20
2019-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
TREATMENT
TRIPLE
Study Groups
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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
Paracetamol
The investigators apply paracetamol during a week in preoperative room 45 min before ECT
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
Deksketoprofen trometamol
The investigators apply paracetamol during a week in preoperative room 45 min before ECT
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
Placebo
The investigators apply placebo during a week in preoperative room 45 min before ECT
Interventions
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Paracetamol
The investigators apply paracetamol during a week in preoperative room 45 min before ECT
Deksketoprofen trometamol
The investigators apply paracetamol during a week in preoperative room 45 min before ECT
Placebo
The investigators apply placebo during a week in preoperative room 45 min before ECT
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
18 Years
80 Years
ALL
No
Sponsors
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Mustafa Kemal University
OTHER
Responsible Party
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Onur Koyuncu
Assoc.Prof.MD
Principal Investigators
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Onur Koyuncu, Asc.Prof
Role: PRINCIPAL_INVESTIGATOR
Mustafa Kemal Univ.
Sedat Hakimoglu, Asc.Prof
Role: STUDY_CHAIR
Mustafa Kemal Univ.
Senem Urfalı, Ast.Prof
Role: STUDY_DIRECTOR
Mustafa Kemal Univ.
Sumeyra Yesil, Resident
Role: PRINCIPAL_INVESTIGATOR
Mustafa Kemal Univ.
Locations
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Mustafa Kemal University Medicine Faculty Anesthesiology Department
Hatay, , Turkey (Türkiye)
Countries
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Central Contacts
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Facility Contacts
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References
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Isuru A, Rodrigo A, Wijesinghe C, Ediriweera D, Premadasa S, Wijesekara C, Kuruppuarachchi L. A randomized, double-blind, placebo-controlled trial on the role of preemptive analgesia with acetaminophen [paracetamol] in reducing headache following electroconvulsive therapy [ECT]. BMC Psychiatry. 2017 Jul 28;17(1):275. doi: 10.1186/s12888-017-1444-6.
Other Identifiers
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2018/171
Identifier Type: -
Identifier Source: org_study_id
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