<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/NCT01730326</url>
  </required_header>
  <id_info>
    <org_study_id>turkcuer 001</org_study_id>
    <nct_id>NCT01730326</nct_id>
  </id_info>
  <brief_title>Intravenous Dexketoprofen and Paracetamol in the Treatment of Headache Caused by Acute Migraine Attack</brief_title>
  <official_title>The Comparison of the Effectiveness of Intravenous Dexketoprofen and Paracetamol in the Treatment of Headache Caused by Acute Migraine Attack in Emergency Service</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Pamukkale University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Pamukkale University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Patients with acute migraine attack make up the majority of patients consulting the emergency&#xD;
      services due to headache. The aim of treatment in the emergency service is to achieve a&#xD;
      minimum level of undesirable side effects and to quickly relieve the pain which will not&#xD;
      repeat after discharge from the emergency service. Ideal drug treatment contraindication&#xD;
      should be at a minimum level and not trigger migraine. Paracetamol and Nonsteroidal&#xD;
      anti-inflammatory drugs are often used in the treatment of migraine headache.&#xD;
&#xD;
      Although narcotic analgesics provide effective and rapid analgesia, they have such side&#xD;
      effects as hypotension, nausea and vomiting, drowsiness. In recent years, with the production&#xD;
      of parenteral forms of non-steroidal anti-inflammatory painkillers, the analgesic efficacy of&#xD;
      these drugs has been one of the topics of interest to researchers. Especially intravenous&#xD;
      form of paracetamol is new yet compared to other Nonsteroidal anti-inflammatory drugs, and it&#xD;
      is a drug with a wide safety margin and less incidence of side effects. The effectiveness of&#xD;
      the Intravenous form of paracetamol and whether it can be an alternative to other analgesics&#xD;
      is one of the major research topics today, and more study is needed on this subject.&#xD;
&#xD;
      Both drugs are often used in emergency services to treat headache caused by acute migraine&#xD;
      attack. Our aim is to compare the effectiveness of intravenous dexketoprofen with paracetamol&#xD;
      in the treatment of the headache caused by acute migraine attack.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Materials and Methods of Research:&#xD;
&#xD;
      Among the patients consulting the emergency service with a complaint of headache, those who&#xD;
      meet the criteria of 'International Classification of Headache Disorders criteria for&#xD;
      migraine without aura' and agreed to participate in the study will form the study group.&#xD;
&#xD;
      The patients forming the study group will be included in the study after they are evaluated&#xD;
      according to the criteria of inclusion or exclusion. Our research is an equivalence study.&#xD;
      Provided that the difference between the groups is 50 %, α: 99 %, and 1-β: 80 %, it has been&#xD;
      determined that each group should include at least 94 subjects, and the number of voluntary&#xD;
      subjects has been determined as 200, each group containing 100 subjects.&#xD;
&#xD;
      First of all, in the measurement of the frequency of headaches, the standard 11-point Numeric&#xD;
      Rating Scale (NRS), whose reliability is proven, and 100-mm visual analog scale (VAS) will be&#xD;
      used. For NRS, patients will be asked to score their pain on a scale ranging from 0 to 10,&#xD;
      scoring 0 (zero) in the absence of pain, and 10 in the case of most severe pain; whereas, for&#xD;
      VAS, they will be asked to score their pain on a scale ranging from 0 to 100, scoring 0 in&#xD;
      the absence of pain, and 100 in the case of most severe pain. Verbal rating scale (VRS) with&#xD;
      4 standard points will be used as another measurement tool. In this measurement, patients&#xD;
      will be asked to express their pain as severe, moderate, mild and no pain.&#xD;
&#xD;
      The patients will be divided to two groups.&#xD;
&#xD;
      Groups and drug doses to be given;&#xD;
&#xD;
        1. group: Dexketoprofen Trometamol (50 mg)&#xD;
&#xD;
        2. group: Paracetamol (1000 mg)&#xD;
&#xD;
      The drug which will be given after randomization will be diluted in 150 ml serum physiologic&#xD;
      and will be given as intravenous rapid infusion.&#xD;
&#xD;
      The pains of the patients will be assessed in 0., 15. and 30. minutes by NRS, VAS and VRS,&#xD;
      and they will be monitored for vital signs and possible side effects.&#xD;
&#xD;
      In 30. minute, the study will be ended, and If the pain continues, fentanyl 1 mcg / kg will&#xD;
      be given.&#xD;
&#xD;
      When a patient eligible for the study consults, after obtaining the patient's written&#xD;
      consent, the patient will be assigned to one of the study groups based on the next study&#xD;
      number. Randomization of study numbers will be prepared by someone other than a person&#xD;
      working in the emergency service with the help of a computer, and until the completion of the&#xD;
      study, which number is assigned to which drug will be known only by that person. One of the&#xD;
      nurses working in the emergency department will be responsible for preparing the study drug,&#xD;
      while the other nurse blindly will be responsible for giving the study drug. The numbers&#xD;
      belong to the previously enumerated study groups will be stored in envelopes which do not&#xD;
      show the inside (allocation concealment), and the study drug will be prepared after the next&#xD;
      envelope is opened by the study nurse. Patients eligible for the study will be taken to the&#xD;
      unit called 'observation with monitor' in the emergency department, monitored and IV vascular&#xD;
      access will be established. The study drugs will be prepared by the emergency nurse&#xD;
      responsible for the study and will be given by the other nurse. Medicines prepared for each&#xD;
      group are transparent and same.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>March 2012</start_date>
  <completion_date type="Actual">November 2012</completion_date>
  <primary_completion_date type="Actual">July 2012</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>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Triple (Participant, Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Reduction in visual analogue scale and Numeric Rating Scale</measure>
    <time_frame>15 minutes interval</time_frame>
    <description>The pain of the study subjects was measured after 15th and 30th minutes later after the study drug administered.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Adverse events</measure>
    <time_frame>30th minutes after</time_frame>
    <description>30th minutes after the study drug administered</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Reduction in verbal rating scale</measure>
    <time_frame>15 minutes interval</time_frame>
    <description>The pain of the study subjects was measured after 15th and 30th minutes later after the study drug administered.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">200</enrollment>
  <condition>Acute Migraine</condition>
  <arm_group>
    <arm_group_label>Paracetamol</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Paracetamol which will be given after randomization will be diluted in serum physiologic and will be given as intravenous rapid infusion.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Dexketoprofen</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Dexketoprofen which will be given after randomization will be diluted in serum physiologic and will be given as intravenous rapid infusion.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Paracetamol</intervention_name>
    <description>1000 mg</description>
    <arm_group_label>Paracetamol</arm_group_label>
    <other_name>perfalgan 10 mg/ml</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Dexketoprofen</intervention_name>
    <description>50 mg</description>
    <arm_group_label>Dexketoprofen</arm_group_label>
    <other_name>arveles 50 mg/2 ml</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        1. Inclusion Criteria:&#xD;
&#xD;
             a. Patients who are 18 years of age and older, and who agreed to participate in the&#xD;
             study will be included in the study.&#xD;
&#xD;
          2. Exclusion Criteria:&#xD;
&#xD;
               1. Patients having received analgesic in the last six hours,&#xD;
&#xD;
               2. pregnant women,&#xD;
&#xD;
               3. women of childbearing potential and not using birth control,&#xD;
&#xD;
               4. those who do not agree to participate in the study,&#xD;
&#xD;
               5. those under age of 18, those who have signs of peritoneal irritation,&#xD;
&#xD;
               6. those who are allergic to drugs used in the study,&#xD;
&#xD;
               7. hemodynamically unstable patients,&#xD;
&#xD;
               8. patients with renal transplant,&#xD;
&#xD;
               9. those who suffer from liver, kidney, cardiac and pulmonary insufficiency and&#xD;
                  others with systemic diseases,&#xD;
&#xD;
              10. patients with vision problems and those who are illiterate will be excluded from&#xD;
                  the study.&#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>Ibrahim Turkcuer, assoc. prof.</last_name>
    <role>Study Director</role>
    <affiliation>Pamukkale University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Pamukkale University Hospital, Emergency Department</name>
      <address>
        <city>Denizli</city>
        <zip>20020</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <reference>
    <citation>Hewitt DJ, Martin V, Lipton RB, Brandes J, Ceesay P, Gottwald R, Schaefer E, Lines C, Ho TW. Randomized controlled study of telcagepant plus ibuprofen or acetaminophen in migraine. Headache. 2011 Apr;51(4):533-43. doi: 10.1111/j.1526-4610.2011.01860.x.</citation>
    <PMID>21457238</PMID>
  </reference>
  <reference>
    <citation>Prior MJ, Codispoti JR, Fu M. A randomized, placebo-controlled trial of acetaminophen for treatment of migraine headache. Headache. 2010 May;50(5):819-33. doi: 10.1111/j.1526-4610.2010.01638.x. Epub 2010 Mar 5.</citation>
    <PMID>20236342</PMID>
  </reference>
  <verification_date>November 2012</verification_date>
  <study_first_submitted>November 5, 2012</study_first_submitted>
  <study_first_submitted_qc>November 15, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 21, 2012</study_first_posted>
  <last_update_submitted>November 15, 2012</last_update_submitted>
  <last_update_submitted_qc>November 15, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 21, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Pamukkale University</investigator_affiliation>
    <investigator_full_name>Mustafa Serinken</investigator_full_name>
    <investigator_title>Pamukkale University denizli / TURKEY</investigator_title>
  </responsible_party>
  <keyword>Headache</keyword>
  <keyword>paracetamol</keyword>
  <keyword>dexketoprofen</keyword>
  <keyword>emergency department</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Migraine Disorders</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>Dexketoprofen trometamol</mesh_term>
  </intervention_browse>
  <!-- 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/NCT01730326
org study id: turkcuer 001
nct id: NCT01730326
lead sponsor: 
has dmc: Yes
Patients with acute migraine attack make up the majority of patients consulting the emergency
      services due to headache. The aim of treatment in the emergency service is to achieve a
      minimum level of undesirable side effects and to quickly relieve the pain which will not
      repeat after discharge from the emergency service. Ideal drug treatment contraindication
      should be at a minimum level and not trigger migraine. Paracetamol and Nonsteroidal
      anti-inflammatory drugs are often used in the treatment of migraine headache.

      Although narcotic analgesics provide effective and rapid analgesia, they have such side
      effects as hypotension, nausea and vomiting, drowsiness. In recent years, with the production
      of parenteral forms of non-steroidal anti-inflammatory painkillers, the analgesic efficacy of
      these drugs has been one of the topics of interest to researchers. Especially intravenous
      form of paracetamol is new yet compared to other Nonsteroidal anti-inflammatory drugs, and it
      is a drug with a wide safety margin and less incidence of side effects. The effectiveness of
      the Intravenous form of paracetamol and whether it can be an alternative to other analgesics
      is one of the major research topics today, and more study is needed on this subject.

      Both drugs are often used in emergency services to treat headache caused by acute migraine
      attack. Our aim is to compare the effectiveness of intravenous dexketoprofen with paracetamol
      in the treatment of the headache caused by acute migraine attack.
Materials and Methods of Research:

      Among the patients consulting the emergency service with a complaint of headache, those who
      meet the criteria of 'International Classification of Headache Disorders criteria for
      migraine without aura' and agreed to participate in the study will form the study group.

      The patients forming the study group will be included in the study after they are evaluated
      according to the criteria of inclusion or exclusion. Our research is an equivalence study.
      Provided that the difference between the groups is 50 %, α: 99 %, and 1-β: 80 %, it has been
      determined that each group should include at least 94 subjects, and the number of voluntary
      subjects has been determined as 200, each group containing 100 subjects.

      First of all, in the measurement of the frequency of headaches, the standard 11-point Numeric
      Rating Scale (NRS), whose reliability is proven, and 100-mm visual analog scale (VAS) will be
      used. For NRS, patients will be asked to score their pain on a scale ranging from 0 to 10,
      scoring 0 (zero) in the absence of pain, and 10 in the case of most severe pain; whereas, for
      VAS, they will be asked to score their pain on a scale ranging from 0 to 100, scoring 0 in
      the absence of pain, and 100 in the case of most severe pain. Verbal rating scale (VRS) with
      4 standard points will be used as another measurement tool. In this measurement, patients
      will be asked to express their pain as severe, moderate, mild and no pain.

      The patients will be divided to two groups.

      Groups and drug doses to be given;

        1. group: Dexketoprofen Trometamol (50 mg)

        2. group: Paracetamol (1000 mg)

      The drug which will be given after randomization will be diluted in 150 ml serum physiologic
      and will be given as intravenous rapid infusion.

      The pains of the patients will be assessed in 0., 15. and 30. minutes by NRS, VAS and VRS,
      and they will be monitored for vital signs and possible side effects.

      In 30. minute, the study will be ended, and If the pain continues, fentanyl 1 mcg / kg will
      be given.

      When a patient eligible for the study consults, after obtaining the patient's written
      consent, the patient will be assigned to one of the study groups based on the next study
      number. Randomization of study numbers will be prepared by someone other than a person
      working in the emergency service with the help of a computer, and until the completion of the
      study, which number is assigned to which drug will be known only by that person. One of the
      nurses working in the emergency department will be responsible for preparing the study drug,
      while the other nurse blindly will be responsible for giving the study drug. The numbers
      belong to the previously enumerated study groups will be stored in envelopes which do not
      show the inside (allocation concealment), and the study drug will be prepared after the next
      envelope is opened by the study nurse. Patients eligible for the study will be taken to the
      unit called 'observation with monitor' in the emergency department, monitored and IV vascular
      access will be established. The study drugs will be prepared by the emergency nurse
      responsible for the study and will be given by the other nurse. Medicines prepared for each
      group are transparent and same.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Investigator)
measure: Reduction in visual analogue scale and Numeric Rating Scale
time frame: 15 minutes interval
description: The pain of the study subjects was measured after 15th and 30th minutes later after the study drug administered.
measure: Adverse events
time frame: 30th minutes after
description: 30th minutes after the study drug administered
measure: Reduction in verbal rating scale
time frame: 15 minutes interval
description: The pain of the study subjects was measured after 15th and 30th minutes later after the study drug administered.
arm group label: Paracetamol
arm group type: Experimental
description: Paracetamol which will be given after randomization will be diluted in serum physiologic and will be given as intravenous rapid infusion.
arm group label: Dexketoprofen
arm group type: Active Comparator
description: Dexketoprofen which will be given after randomization will be diluted in serum physiologic and will be given as intravenous rapid infusion.
intervention type: Drug
intervention name: Paracetamol
description: 1000 mg
arm group label: Paracetamol
other name: perfalgan 10 mg/ml
intervention type: Drug
intervention name: Dexketoprofen
description: 50 mg
arm group label: Dexketoprofen
other name: arveles 50 mg/2 ml
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Ibrahim Turkcuer, assoc. prof.
role: Study Director
affiliation: Pamukkale University
facility: 
country: Turkey
citation: Hewitt DJ, Martin V, Lipton RB, Brandes J, Ceesay P, Gottwald R, Schaefer E, Lines C, Ho TW. Randomized controlled study of telcagepant plus ibuprofen or acetaminophen in migraine. Headache. 2011 Apr;51(4):533-43. doi: 10.1111/j.1526-4610.2011.01860.x.
PMID: 21457238
citation: Prior MJ, Codispoti JR, Fu M. A randomized, placebo-controlled trial of acetaminophen for treatment of migraine headache. Headache. 2010 May;50(5):819-33. doi: 10.1111/j.1526-4610.2010.01638.x. Epub 2010 Mar 5.
PMID: 20236342
responsible party type: Principal Investigator
investigator affiliation: Pamukkale University
investigator full name: Mustafa Serinken
investigator title: Pamukkale University denizli / TURKEY
mesh term: Migraine Disorders
mesh term: Headache
mesh term: Acetaminophen
mesh term: Dexketoprofen trometamol