<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03830398</url>
  </required_header>
  <id_info>
    <org_study_id>2018/171</org_study_id>
    <nct_id>NCT03830398</nct_id>
  </id_info>
  <brief_title>Comparison of Drugs on Headache Treatment After ECT Treatment</brief_title>
  <official_title>Comparison of Paracetamol and Dexketoprofen Trometamol on Headache Treatment After Electroconvulsive Treatment</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Mustafa Kemal University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Mustafa Kemal University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Electroconvulsive treatment (ECT) is still actual for treatment of psychiatric symptoms.&#xD;
      Headache is a very common symptom after this application. The investigators compare the&#xD;
      effect of two different drugs for the treatment of headache after ECT.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Electroconvulsive treatment (ECT) is used as an alternative application instead of drug&#xD;
      therapy for psychiatric symptoms. ECT application is repeated 8-12 times according to the&#xD;
      treatment of the patient. This treatment is done in 2 or 3 days intervals. The most adverse&#xD;
      effects of ECT are headache, memory disorders, myalgia, nausea and vomiting, cardiovascular&#xD;
      problems. The most common seen adverse effect is headache with approximately 60% incidence.&#xD;
      The main drugs used for the treatment of headache related to ECT are NSAIs and paracetamol.&#xD;
      The aim of the current study is to compare the effect of paracetamol and dexketoprofen&#xD;
      trometamol on headache treatment after ECT.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">November 20, 2018</start_date>
  <completion_date type="Anticipated">June 2019</completion_date>
  <primary_completion_date type="Anticipated">May 2019</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Sequential Assignment</intervention_model>
    <intervention_model_description>Each drug for one week</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Triple (Participant, Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Headache (Visual Analogue Scale 0-10)</measure>
    <time_frame>Postoperative 2. hour, 4. hour, 6. hour (up to six hours after intervention)</time_frame>
    <description>Headache (VAS) change is being assessed in three different time frames after ECT</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Additive analgesic-antiemetic consumption</measure>
    <time_frame>Postoperative 2. hour, 4. hour, 6. hour (up to six hours after intervention)</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adverse effects (Nausea-Vomiting, bradycardia, hypotension)</measure>
    <time_frame>Postoperative 2. hour, 4. hour, 6. hour (up to six hours after intervention)</time_frame>
    <description>Number of adverse efffects will be recorded in each interval.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">225</enrollment>
  <condition>Mental Disorders</condition>
  <arm_group>
    <arm_group_label>Paracetamol</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>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</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Deksketoprofen trometamol</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>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</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>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</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Paracetamol</intervention_name>
    <description>The investigators apply paracetamol during a week in preoperative room 45 min before ECT</description>
    <arm_group_label>Paracetamol</arm_group_label>
    <other_name>Parol</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Deksketoprofen trometamol</intervention_name>
    <description>The investigators apply paracetamol during a week in preoperative room 45 min before ECT</description>
    <arm_group_label>Deksketoprofen trometamol</arm_group_label>
    <other_name>Sertofen</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>The investigators apply placebo during a week in preoperative room 45 min before ECT</description>
    <arm_group_label>Placebo</arm_group_label>
    <other_name>Serum Physiologic</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All patients who were admitted for ECT and gave informed written consent were included&#xD;
             in the study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Exclusion criteria included patients who gave a history of allergy to acetaminophen,&#xD;
             lacked capacity to give informed consent and developed complications such as delirium&#xD;
             following ECT.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Onur Koyuncu, Asc.Prof</last_name>
    <role>Principal Investigator</role>
    <affiliation>Mustafa Kemal Univ.</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Sedat Hakimoglu, Asc.Prof</last_name>
    <role>Study Chair</role>
    <affiliation>Mustafa Kemal Univ.</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Senem Urfalı, Ast.Prof</last_name>
    <role>Study Director</role>
    <affiliation>Mustafa Kemal Univ.</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Sumeyra Yesil, Resident</last_name>
    <role>Principal Investigator</role>
    <affiliation>Mustafa Kemal Univ.</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Cagla Buket Akkurt, Prof</last_name>
    <phone>+905053783204</phone>
    <email>caglabuket@gmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Mustafa Kemal University Medicine Faculty Anesthesiology Department</name>
      <address>
        <city>Hatay</city>
        <zip>31000</zip>
        <country>Turkey</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Onur Koyuncu, Assist. Prof</last_name>
      <phone>5337744757</phone>
      <email>onurko@yahoo.com</email>
    </contact>
    <investigator>
      <last_name>Onur Koyuncu, Assoc.Prof</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Sedat Hakimoglu, Assoc.Prof</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Senem Urfali, Ast.Prof</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Sumeyra Yesil, M.D.</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <results_reference>
    <citation>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.</citation>
    <PMID>28754173</PMID>
  </results_reference>
  <verification_date>February 2019</verification_date>
  <study_first_submitted>January 15, 2019</study_first_submitted>
  <study_first_submitted_qc>February 2, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 5, 2019</study_first_posted>
  <last_update_submitted>February 2, 2019</last_update_submitted>
  <last_update_submitted_qc>February 2, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 5, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Mustafa Kemal University</investigator_affiliation>
    <investigator_full_name>Onur Koyuncu</investigator_full_name>
    <investigator_title>Assoc.Prof.MD</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Headache</mesh_term>
    <mesh_term>Mental Disorders</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Acetaminophen</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03830398
org study id: 2018/171
nct id: NCT03830398
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
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.
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.
allocation: Randomized
intervention model: Sequential Assignment
intervention model description: Each drug for one week
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Investigator)
measure: Headache (Visual Analogue Scale 0-10)
time frame: Postoperative 2. hour, 4. hour, 6. hour (up to six hours after intervention)
description: Headache (VAS) change is being assessed in three different time frames after ECT
measure: Additive analgesic-antiemetic consumption
time frame: Postoperative 2. hour, 4. hour, 6. hour (up to six hours after intervention)
description: 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.
measure: Adverse effects (Nausea-Vomiting, bradycardia, hypotension)
time frame: Postoperative 2. hour, 4. hour, 6. hour (up to six hours after intervention)
description: Number of adverse efffects will be recorded in each interval.
arm group label: Paracetamol
arm group type: Active Comparator
description: 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
arm group label: Deksketoprofen trometamol
arm group type: Active Comparator
description: 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
arm group label: Placebo
arm group type: Placebo Comparator
description: 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
intervention type: Drug
intervention name: Paracetamol
description: The investigators apply paracetamol during a week in preoperative room 45 min before ECT
arm group label: Paracetamol
other name: Parol
intervention type: Drug
intervention name: Deksketoprofen trometamol
description: The investigators apply paracetamol during a week in preoperative room 45 min before ECT
arm group label: Deksketoprofen trometamol
other name: Sertofen
intervention type: Drug
intervention name: Placebo
description: The investigators apply placebo during a week in preoperative room 45 min before ECT
arm group label: Placebo
other name: Serum Physiologic
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Onur Koyuncu, Asc.Prof
role: Principal Investigator
affiliation: Mustafa Kemal Univ.
last name: Sedat Hakimoglu, Asc.Prof
role: Study Chair
affiliation: Mustafa Kemal Univ.
last name: Senem Urfalı, Ast.Prof
role: Study Director
affiliation: Mustafa Kemal Univ.
last name: Sumeyra Yesil, Resident
role: Principal Investigator
affiliation: Mustafa Kemal Univ.
last name: Cagla Buket Akkurt, Prof
phone: +905053783204
email: caglabuket@gmail.com
facility: 
status: Recruiting
contact: 
investigator: 
investigator: 
investigator: 
investigator: 
country: Turkey
citation: 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.
PMID: 28754173
responsible party type: Principal Investigator
investigator affiliation: Mustafa Kemal University
investigator full name: Onur Koyuncu
investigator title: Assoc.Prof.MD
mesh term: Headache
mesh term: Mental Disorders
mesh term: Acetaminophen
sharing ipd: Undecided