<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/NCT03768882</url>
  </required_header>
  <id_info>
    <org_study_id>2018TPF012</org_study_id>
    <nct_id>NCT03768882</nct_id>
  </id_info>
  <brief_title>Comparison of the Efficacy of Intravenous Dexketoprofen and Paracetamol in the Treatment of Sore Throat</brief_title>
  <official_title>Comparison of the Efficacy of Intravenous Dexketoprofen and Paracetamol in the Treatment of Pain in Patients Presenting to the Emergency Department With Sore Throat: A Double-Blinded, Randomized, Controlled Trial</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>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Currently, paracetamol and nonsteroidal antiinflammatory drugs are widely used by emergency&#xD;
      physicians in Turkey for the treatment of sore throat. The objective of the study is compare&#xD;
      the efficacy of intravenous dexketoprofen and paracetamol in the treatment of the pain in&#xD;
      patients presenting to the emergency department with sore throat&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is the randomized double blinded clinical trial to compare the efficacy of these two&#xD;
      drugs in this clinical setting. A randomized clinical trial was conducted in the Emergency&#xD;
      Department (ED) of Pamukkale University Medical Faculty Hospital Study personnel (emergency&#xD;
      physicians and emergency service nurses) were trained before the study.&#xD;
&#xD;
      When intravenous drugs (Paracetamol, Dexketoprofen) was being recommended, an eligibility&#xD;
      checklist was completed by the attending physician. Sore throat pain intensity scale was used&#xD;
      to measure the severity of sore throat. According to the throat pain scale, patients with&#xD;
      moderate-severe pain, at least 1 upper respiratory tract infection (URTI) symptom according&#xD;
      URTI questionare, with objective findings of pharyngeal inflammation (Tonsillopharyngitis&#xD;
      evaluation score ≥5), 60 mm or more according to the sore throat sensitivity scale (STSS), 50&#xD;
      mm and above according to difficulty swallowing scale (DSS), 33 mm and above according to the&#xD;
      swollen throat scale (SwoTS) were included in the study and evaluated according to these&#xD;
      scales.&#xD;
&#xD;
      First Group: 1000 mg of paracetamol ( parol 10mg/ml solution Mefar, Turkey) intravenous (IV)&#xD;
      was given 100 patients, Second Group:&#xD;
&#xD;
      dexketoprofen 50 mg ( arveles ampoule -IE Ulagay-Menarini, Turkey) intravenous (IV) was given&#xD;
      100 patients which determined to be applied as a group.&#xD;
&#xD;
      Drug packs prepared in 150 ml serum physiology were numbered by an independent nurse, who not&#xD;
      involved in the study Randomization was achieved by using computer software to generate&#xD;
      random numbers. During the intervention, participants were monitored by an oxygen saturation&#xD;
      (SpO2) monitor, an automatic sphygmomanometer (blood pressure), and a rhythm monitor (heart&#xD;
      rate and rhythms).&#xD;
&#xD;
      Patients in both groups received two types of medication in a similarmanner, thus ensuring&#xD;
      double blind.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 1, 2017</start_date>
  <completion_date type="Actual">July 30, 2018</completion_date>
  <primary_completion_date type="Actual">July 30, 2018</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>Factorial Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Triple (Participant, Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Decreament of the pain</measure>
    <time_frame>Baseline and 120 minutes</time_frame>
    <description>Comparison of the change of sore thorat pain VAS (visual analog scale) and Sore throat relief scale score between the two groups. - (First group Paracetamol and Second Dexketoprofen)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Symptom frequency</measure>
    <time_frame>Baseline and 120 minutes</time_frame>
    <description>Detection of upper respiratory tract infections symptoms frequency by using upper respiratory tract infections questionnaire</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">200</enrollment>
  <condition>Sore Throat</condition>
  <arm_group>
    <arm_group_label>Paracetamol</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Experimental: Paracetamol 1000 mg of paracetamol (parol 10mg/ml solution Mefar,Turkey ) intravenous (IV) was given 102 patients</description>
  </arm_group>
  <arm_group>
    <arm_group_label>dexketoprofen</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Dexketoprofen Second group: dexketoprofen 50 MG (Arveles ampoule -İE Ulagay-Menarini,Turkey) intravenous (IV) was given 98 patients</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>paracetamol</intervention_name>
    <description>1000 mg of paracetamol (parol 10mg/ml Mefar, Turkey) intravenous (IV) was given 102 patients</description>
    <arm_group_label>Paracetamol</arm_group_label>
    <other_name>Perfalgan</other_name>
    <other_name>Paracerol</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Dexketoprofen</intervention_name>
    <description>Second group: dexketoprofen 50 MG (Arveles ampoule -İE Ulagay -Menarini,Turkey) intravenous (IV) was given 98 patients</description>
    <arm_group_label>dexketoprofen</arm_group_label>
    <other_name>ASEKET</other_name>
    <other_name>DARKIN</other_name>
    <other_name>DEXALGIN</other_name>
    <other_name>DESTIYO</other_name>
    <other_name>DEXCORIL</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with sore throat less than three days&#xD;
&#xD;
          -  Patients with at least one of the following:&#xD;
&#xD;
          -  According to the throat pain scale, patients with moderate-severe pain,&#xD;
&#xD;
          -  At least 1 upper respiratory tract infection (URTI) symptom according URTI&#xD;
             questionare,&#xD;
&#xD;
          -  Objective findings of pharyngeal inflammation (Tonsillopharyngitis evaluation score&#xD;
             ≥5),&#xD;
&#xD;
          -  60 mm or more according to the sore throat sensitivity scale (STSS),&#xD;
&#xD;
          -  50 mm and above according to difficulty swallowing scale (DSS),&#xD;
&#xD;
          -  33 mm and above according to the swollen throat scale (SwoTS)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients use analgesic last 12 hours&#xD;
&#xD;
          -  Patients with severe liver, kidney,pulmonary and cardiac heart failure&#xD;
&#xD;
          -  To be Pregnancy and breast-feeding Patients of childbearing age who are not using a&#xD;
             birth control method&#xD;
&#xD;
          -  Patients with an allergy trait (paracetamol and dexketoprofen) Illiterates&#xD;
&#xD;
          -  Patients with vision problems&#xD;
&#xD;
          -  Patients use antibiotics last 24 hours&#xD;
&#xD;
          -  Patients use kinolons last 7 days&#xD;
&#xD;
          -  Patienst use lozange,throat spray or menthol containing products last 4 hours&#xD;
&#xD;
          -  Hemodynamically unstable patients,Patients with renal transplantation&#xD;
&#xD;
          -  Patients with glucose 6 phosphate dehydrogenase (G6PD) deficiency&#xD;
&#xD;
          -  Patients with non-controlled hypertension&#xD;
&#xD;
          -  Patients with a history of cerebrovascular disease&#xD;
&#xD;
          -  Patients with Wolff-Parkinson-White syndrome or accompanying arrhythmias associated&#xD;
             with conductive stimulus delivery in the heart&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Uzeyir Cimen, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Pamukkale University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Pamukkale University</name>
      <address>
        <city>Denizli</city>
        <zip>20070</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>November 21, 2018</study_first_submitted>
  <study_first_submitted_qc>December 6, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 7, 2018</study_first_posted>
  <last_update_submitted>December 6, 2018</last_update_submitted>
  <last_update_submitted_qc>December 6, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 10, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Pamukkale University</investigator_affiliation>
    <investigator_full_name>Üzeyir Çimen</investigator_full_name>
    <investigator_title>Research Assistant</investigator_title>
  </responsible_party>
  <keyword>paracetamol,dexketoprofen,emergency department,sore throat</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pharyngitis</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>
  <patient_data>
    <sharing_ipd>No</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/NCT03768882
org study id: 2018TPF012
nct id: NCT03768882
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Currently, paracetamol and nonsteroidal antiinflammatory drugs are widely used by emergency
      physicians in Turkey for the treatment of sore throat. The objective of the study is compare
      the efficacy of intravenous dexketoprofen and paracetamol in the treatment of the pain in
      patients presenting to the emergency department with sore throat
This is the randomized double blinded clinical trial to compare the efficacy of these two
      drugs in this clinical setting. A randomized clinical trial was conducted in the Emergency
      Department (ED) of Pamukkale University Medical Faculty Hospital Study personnel (emergency
      physicians and emergency service nurses) were trained before the study.

      When intravenous drugs (Paracetamol, Dexketoprofen) was being recommended, an eligibility
      checklist was completed by the attending physician. Sore throat pain intensity scale was used
      to measure the severity of sore throat. According to the throat pain scale, patients with
      moderate-severe pain, at least 1 upper respiratory tract infection (URTI) symptom according
      URTI questionare, with objective findings of pharyngeal inflammation (Tonsillopharyngitis
      evaluation score ≥5), 60 mm or more according to the sore throat sensitivity scale (STSS), 50
      mm and above according to difficulty swallowing scale (DSS), 33 mm and above according to the
      swollen throat scale (SwoTS) were included in the study and evaluated according to these
      scales.

      First Group: 1000 mg of paracetamol ( parol 10mg/ml solution Mefar, Turkey) intravenous (IV)
      was given 100 patients, Second Group:

      dexketoprofen 50 mg ( arveles ampoule -IE Ulagay-Menarini, Turkey) intravenous (IV) was given
      100 patients which determined to be applied as a group.

      Drug packs prepared in 150 ml serum physiology were numbered by an independent nurse, who not
      involved in the study Randomization was achieved by using computer software to generate
      random numbers. During the intervention, participants were monitored by an oxygen saturation
      (SpO2) monitor, an automatic sphygmomanometer (blood pressure), and a rhythm monitor (heart
      rate and rhythms).

      Patients in both groups received two types of medication in a similarmanner, thus ensuring
      double blind.
allocation: Randomized
intervention model: Factorial Assignment
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Investigator)
measure: Decreament of the pain
time frame: Baseline and 120 minutes
description: Comparison of the change of sore thorat pain VAS (visual analog scale) and Sore throat relief scale score between the two groups. - (First group Paracetamol and Second Dexketoprofen)
measure: Symptom frequency
time frame: Baseline and 120 minutes
description: Detection of upper respiratory tract infections symptoms frequency by using upper respiratory tract infections questionnaire
arm group label: Paracetamol
arm group type: Experimental
description: Experimental: Paracetamol 1000 mg of paracetamol (parol 10mg/ml solution Mefar,Turkey ) intravenous (IV) was given 102 patients
arm group label: dexketoprofen
arm group type: Experimental
description: Dexketoprofen Second group: dexketoprofen 50 MG (Arveles ampoule -İE Ulagay-Menarini,Turkey) intravenous (IV) was given 98 patients
intervention type: Drug
intervention name: paracetamol
description: 1000 mg of paracetamol (parol 10mg/ml Mefar, Turkey) intravenous (IV) was given 102 patients
arm group label: Paracetamol
other name: Perfalgan
other name: Paracerol
intervention type: Drug
intervention name: Dexketoprofen
description: Second group: dexketoprofen 50 MG (Arveles ampoule -İE Ulagay -Menarini,Turkey) intravenous (IV) was given 98 patients
arm group label: dexketoprofen
other name: ASEKET
other name: DARKIN
other name: DEXALGIN
other name: DESTIYO
other name: DEXCORIL
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Uzeyir Cimen, MD
role: Principal Investigator
affiliation: Pamukkale University
facility: 
country: Turkey
responsible party type: Principal Investigator
investigator affiliation: Pamukkale University
investigator full name: Üzeyir Çimen
investigator title: Research Assistant
mesh term: Pharyngitis
mesh term: Acetaminophen
mesh term: Dexketoprofen trometamol
sharing ipd: No