<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/NCT03783312</url>
  </required_header>
  <id_info>
    <org_study_id>ekaraaslan1</org_study_id>
    <nct_id>NCT03783312</nct_id>
  </id_info>
  <brief_title>Effects of Preemptive Paracetamol and Ibuprofen on Headache and Myalgia in Patients After Electroconvulsive Therapy</brief_title>
  <acronym>ECT</acronym>
  <official_title>Effects of Preemptive Intravenous Paracetamol and Ibuprofen on Headache and Myalgia in Patients After Electroconvulsive Therapy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Inonu University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Inonu 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>
  </oversight_info>
  <brief_summary>
    <textblock>
      The primary aim this prospective, randomized, double-blind, placebo-controlled clinical trial&#xD;
      is to compare the analgesic effects of preemptive intravenous paracetamol and ibuprofen on&#xD;
      headache and myalgia, and secondary aim is to evaluate the effects on hemodynamics, duration&#xD;
      of seizure and postoperative side effects in patients who underwent electroconvulsive therapy&#xD;
      .&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Electroconvulsive therapy (ECT) is one of the effective and life-saving treatment modality&#xD;
      used in psychiatry for a long time because it responds more rapidly than pharmacological&#xD;
      treatment. ECT is used safely in treatment-resistant depression, and in psychiatric disorders&#xD;
      such as mania, schizoaffective disorder, schizophrenia, catatonia, and neuroleptic malignant&#xD;
      syndrome. Treatment response to ECT in patients with severe depression and mania was reported&#xD;
      as 83% and 78%, respectively.&#xD;
&#xD;
      The electrical stimulation applied to the brain in ECT stimulates neuronal cells and a&#xD;
      generalized tonic clonic seizure usually occurs for 20 to 60 seconds. ECT is performed 3&#xD;
      times a week for a total of 6-12 sessions.&#xD;
&#xD;
      The exact mechanism of ECT is not known, but (1) release of neurotransmitters such as&#xD;
      dopamine, serotonin and norepinephrine (2) hypothalamic release of hormones such as prolactin&#xD;
      and endorphins (3) gamma-aminobutyric acid conduction (4) increase in neurotrophic signaling&#xD;
      and neurogenesis induction, and (5) factors such as changing the connection between different&#xD;
      parts of the brain are thought to play a role.&#xD;
&#xD;
      Although studies have shown the effectiveness of ECT in treatment, low mortality and&#xD;
      morbidity rates, and several side effects have been reported. These; oral cavity damage to&#xD;
      tongue, teeth, implants or intraosseous denture supports; confusion; dizziness; nausea and&#xD;
      vomiting; headache, and myalgia.&#xD;
&#xD;
      The etiology of headache after ECT is not fully understood; however, studies suggest that&#xD;
      rapid contraction of the temporalis and masseter muscles due to ECT, vascular changes and&#xD;
      serotonergic neurotransmission trigger headache. Headaches have been reported to be mild,&#xD;
      moderate or severe and, in some cases, resistant to treatment.&#xD;
&#xD;
      One of the most common side effects of ECT is myalgia. In some cases it is quite severe. The&#xD;
      mechanism of myalgia is not fully known. Muscle contractions and muscle fasciculation due to&#xD;
      succinylcholine use are thought to be effective in the formation of myalgia during the&#xD;
      seizure induced by ECT. There are also studies showing that the using of succinylcholine is&#xD;
      effective on the severity of myalgia.&#xD;
&#xD;
      In cases with myalgia and headache are severe and untreated, patients cannot tolerate the&#xD;
      pain. This may lead to discontinuation of treatment. Effective analgesic treatment is&#xD;
      important for continued treatment and patient comfort.&#xD;
&#xD;
      Painful stimuli from damaged tissue causes sensitization in peripheral and central pain&#xD;
      pathways. Preemptive analgesia is a treatment that was initiated before the surgical&#xD;
      procedure to reduce this sensitization and to inhibit the response to nociceptive stimuli.&#xD;
      Preemptive analgesia has been described as an effective method to prevent headache after ECT.&#xD;
&#xD;
      The primary aim this prospective, randomized, double-blind, placebo-controlled clinical trial&#xD;
      is to compare the analgesic effects of preemptive intravenous paracetamol and ibuprofen on&#xD;
      headache and myalgia, and secondary aim is to evaluate the effects on hemodynamics, duration&#xD;
      of seizure and postoperative side effects in patients who underwent ECT.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 20, 2018</start_date>
  <completion_date type="Actual">February 10, 2019</completion_date>
  <primary_completion_date type="Actual">February 7, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>Prospective, Randomized, Placebo-Controlled Clinical Trial</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
    <masking_description>Single (Participant)</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Postoperative pain scores</measure>
    <time_frame>From end of anesthesia (15 minutes after anesthesia) to after 24 hours, up to 24 hours</time_frame>
    <description>Visual Analog Scale (Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured.It is often used in epidemiologic and clinical research to measure the intensity or frequency of various pain. minimum: 0, maximum: 10, 0: no pain, 1-3: mild pain, 4-6: moderate pain, 7-10: severe pain)</description>
  </primary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">60</enrollment>
  <condition>Postoperative Pain</condition>
  <condition>Myalgia</condition>
  <condition>Headache</condition>
  <arm_group>
    <arm_group_label>placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>250 ml saline will be administered 60 minutes before the onset of Electroconvulsive therapy procedure. Electroconvulsive therapy (ECT) is one of the effective and life-saving treatment modality used in psychiatry for a long time because it responds more rapidly than pharmacological treatment.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>paracetamol</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>1 g paracetamol will be administered 60 minutes before the onset of Electroconvulsive therapy procedure. Electroconvulsive therapy (ECT) is one of the effective and life-saving treatment modality used in psychiatry for a long time because it responds more rapidly than pharmacological treatment.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>ibuprofen</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>800 mg ibuprofen will be administered 60 minutes before the onset of Electroconvulsive therapy procedure. Electroconvulsive therapy (ECT) is one of the effective and life-saving treatment modality used in psychiatry for a long time because it responds more rapidly than pharmacological treatment.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>placebo</intervention_name>
    <description>250 ml saline will be administered 60 minutes before the onset of Electroconvulsive therapy procedure. All administrations will be applied through IV infusion over 60 minutes.</description>
    <arm_group_label>placebo</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>paracetamol</intervention_name>
    <description>1 g paracetamol will be administered 60 minutes before the onset of Electroconvulsive therapy procedure. All administrations will be applied through IV infusion over 60 minutes.</description>
    <arm_group_label>paracetamol</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>ibuprofen</intervention_name>
    <description>800 mg ibuprofen will be administered 60 minutes before the onset of Electroconvulsive therapy procedure. All administrations will be applied through IV infusion over 60 minutes.</description>
    <arm_group_label>ibuprofen</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with major depression&#xD;
&#xD;
          -  Patients with American Society of Anesthesiologists (ASA) scores I or II&#xD;
&#xD;
          -  Between 18-65&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with ASA scores III/IV,&#xD;
&#xD;
          -  Under the age of 18,&#xD;
&#xD;
          -  Over the age of 65,&#xD;
&#xD;
          -  Myocardial infarction,&#xD;
&#xD;
          -  Congestive heart failure,&#xD;
&#xD;
          -  Pulmonary disease,&#xD;
&#xD;
          -  Stroke history,&#xD;
&#xD;
          -  Bleeding disorder,&#xD;
&#xD;
          -  Hepatic and renal dysfunction,&#xD;
&#xD;
          -  Pregnant,&#xD;
&#xD;
          -  Migraine history,&#xD;
&#xD;
          -  Allergy of nonsteroidal anti-inflammatory drugs, paracetamol, propofol,&#xD;
&#xD;
          -  Neuromuscular disease,&#xD;
&#xD;
          -  Peptic ulcer disease,&#xD;
&#xD;
          -  Intracranial hypertension,&#xD;
&#xD;
          -  Glaucoma&#xD;
&#xD;
          -  Patients who did not give informed consent&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Erol Karaaslan, Asst Prof</last_name>
    <role>Study Director</role>
    <affiliation>Inonu University Medical Faculty</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Erol Karaaslan</name>
      <address>
        <city>Malatya</city>
        <state>Türkiye-Türkçe</state>
        <zip>44090</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <reference>
    <citation>Dinwiddie SH, Huo D, Gottlieb O. The course of myalgia and headache after electroconvulsive therapy. J ECT. 2010 Jun;26(2):116-20. doi: 10.1097/YCT.0b013e3181b07c0a.</citation>
    <PMID>19710619</PMID>
  </reference>
  <verification_date>April 2019</verification_date>
  <study_first_submitted>December 14, 2018</study_first_submitted>
  <study_first_submitted_qc>December 18, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 21, 2018</study_first_posted>
  <last_update_submitted>April 2, 2019</last_update_submitted>
  <last_update_submitted_qc>April 2, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">April 3, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Inonu University</investigator_affiliation>
    <investigator_full_name>Erol Karaaslan</investigator_full_name>
    <investigator_title>Asst. Prof. Dr. Erol Karaaslan</investigator_title>
  </responsible_party>
  <keyword>Electroconvulsive therapy</keyword>
  <keyword>Intravenous paracetamol</keyword>
  <keyword>Intravenous ibuprofen</keyword>
  <keyword>Postoperative pain</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Myalgia</mesh_term>
    <mesh_term>Pain, Postoperative</mesh_term>
    <mesh_term>Headache</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Acetaminophen</mesh_term>
    <mesh_term>Ibuprofen</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>September 26, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/12/NCT03783312/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- 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/NCT03783312
org study id: ekaraaslan1
nct id: NCT03783312
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The primary aim this prospective, randomized, double-blind, placebo-controlled clinical trial
      is to compare the analgesic effects of preemptive intravenous paracetamol and ibuprofen on
      headache and myalgia, and secondary aim is to evaluate the effects on hemodynamics, duration
      of seizure and postoperative side effects in patients who underwent electroconvulsive therapy
      .
Electroconvulsive therapy (ECT) is one of the effective and life-saving treatment modality
      used in psychiatry for a long time because it responds more rapidly than pharmacological
      treatment. ECT is used safely in treatment-resistant depression, and in psychiatric disorders
      such as mania, schizoaffective disorder, schizophrenia, catatonia, and neuroleptic malignant
      syndrome. Treatment response to ECT in patients with severe depression and mania was reported
      as 83% and 78%, respectively.

      The electrical stimulation applied to the brain in ECT stimulates neuronal cells and a
      generalized tonic clonic seizure usually occurs for 20 to 60 seconds. ECT is performed 3
      times a week for a total of 6-12 sessions.

      The exact mechanism of ECT is not known, but (1) release of neurotransmitters such as
      dopamine, serotonin and norepinephrine (2) hypothalamic release of hormones such as prolactin
      and endorphins (3) gamma-aminobutyric acid conduction (4) increase in neurotrophic signaling
      and neurogenesis induction, and (5) factors such as changing the connection between different
      parts of the brain are thought to play a role.

      Although studies have shown the effectiveness of ECT in treatment, low mortality and
      morbidity rates, and several side effects have been reported. These; oral cavity damage to
      tongue, teeth, implants or intraosseous denture supports; confusion; dizziness; nausea and
      vomiting; headache, and myalgia.

      The etiology of headache after ECT is not fully understood; however, studies suggest that
      rapid contraction of the temporalis and masseter muscles due to ECT, vascular changes and
      serotonergic neurotransmission trigger headache. Headaches have been reported to be mild,
      moderate or severe and, in some cases, resistant to treatment.

      One of the most common side effects of ECT is myalgia. In some cases it is quite severe. The
      mechanism of myalgia is not fully known. Muscle contractions and muscle fasciculation due to
      succinylcholine use are thought to be effective in the formation of myalgia during the
      seizure induced by ECT. There are also studies showing that the using of succinylcholine is
      effective on the severity of myalgia.

      In cases with myalgia and headache are severe and untreated, patients cannot tolerate the
      pain. This may lead to discontinuation of treatment. Effective analgesic treatment is
      important for continued treatment and patient comfort.

      Painful stimuli from damaged tissue causes sensitization in peripheral and central pain
      pathways. Preemptive analgesia is a treatment that was initiated before the surgical
      procedure to reduce this sensitization and to inhibit the response to nociceptive stimuli.
      Preemptive analgesia has been described as an effective method to prevent headache after ECT.

      The primary aim this prospective, randomized, double-blind, placebo-controlled clinical trial
      is to compare the analgesic effects of preemptive intravenous paracetamol and ibuprofen on
      headache and myalgia, and secondary aim is to evaluate the effects on hemodynamics, duration
      of seizure and postoperative side effects in patients who underwent ECT.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Prospective, Randomized, Placebo-Controlled Clinical Trial
primary purpose: Treatment
masking: Single (Participant)
masking description: Single (Participant)
measure: Postoperative pain scores
time frame: From end of anesthesia (15 minutes after anesthesia) to after 24 hours, up to 24 hours
description: Visual Analog Scale (Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured.It is often used in epidemiologic and clinical research to measure the intensity or frequency of various pain. minimum: 0, maximum: 10, 0: no pain, 1-3: mild pain, 4-6: moderate pain, 7-10: severe pain)
arm group label: placebo
arm group type: Placebo Comparator
description: 250 ml saline will be administered 60 minutes before the onset of Electroconvulsive therapy procedure. Electroconvulsive therapy (ECT) is one of the effective and life-saving treatment modality used in psychiatry for a long time because it responds more rapidly than pharmacological treatment.
arm group label: paracetamol
arm group type: Active Comparator
description: 1 g paracetamol will be administered 60 minutes before the onset of Electroconvulsive therapy procedure. Electroconvulsive therapy (ECT) is one of the effective and life-saving treatment modality used in psychiatry for a long time because it responds more rapidly than pharmacological treatment.
arm group label: ibuprofen
arm group type: Active Comparator
description: 800 mg ibuprofen will be administered 60 minutes before the onset of Electroconvulsive therapy procedure. Electroconvulsive therapy (ECT) is one of the effective and life-saving treatment modality used in psychiatry for a long time because it responds more rapidly than pharmacological treatment.
intervention type: Drug
intervention name: placebo
description: 250 ml saline will be administered 60 minutes before the onset of Electroconvulsive therapy procedure. All administrations will be applied through IV infusion over 60 minutes.
arm group label: placebo
intervention type: Drug
intervention name: paracetamol
description: 1 g paracetamol will be administered 60 minutes before the onset of Electroconvulsive therapy procedure. All administrations will be applied through IV infusion over 60 minutes.
arm group label: paracetamol
intervention type: Drug
intervention name: ibuprofen
description: 800 mg ibuprofen will be administered 60 minutes before the onset of Electroconvulsive therapy procedure. All administrations will be applied through IV infusion over 60 minutes.
arm group label: ibuprofen
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Erol Karaaslan, Asst Prof
role: Study Director
affiliation: Inonu University Medical Faculty
facility: 
country: Turkey
citation: Dinwiddie SH, Huo D, Gottlieb O. The course of myalgia and headache after electroconvulsive therapy. J ECT. 2010 Jun;26(2):116-20. doi: 10.1097/YCT.0b013e3181b07c0a.
PMID: 19710619
responsible party type: Principal Investigator
investigator affiliation: Inonu University
investigator full name: Erol Karaaslan
investigator title: Asst. Prof. Dr. Erol Karaaslan
mesh term: Myalgia
mesh term: Pain, Postoperative
mesh term: Headache
mesh term: Acetaminophen
mesh term: Ibuprofen
sharing ipd: No
provided document: 