xml: <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/NCT05982392</url>
    </required_header>
    <id_info>
      <org_study_id>2889</org_study_id>
      <nct_id>NCT05982392</nct_id>
    </id_info>
    <brief_title>Effect of Preoperative Tramadol and Naproxen Sodium on Post Operative Pain</brief_title>
    <official_title>Effect of Preoperative Tramadol and Naproxen Sodium on Efficacy of Local Anesthesia and Post-operative Pain in Patients With Symptomatic Irreversible Pulpitis</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Dow University of Health Sciences</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Dow University of Health Sciences</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>
        The goal of this clinical trial is to compare in Tramadol, Naproxen sodium and Placebo in&#xD;
        participants presenting with irreversible pulpitis in their mandibular posterior teeth.&#xD;
  &#xD;
        The main question[s] it aims to answer are:&#xD;
  &#xD;
          -  Local anesthetic efficacy and .&#xD;
  &#xD;
          -  Postoperative pain. Participants will receive premedication treatments 60 minutes prior&#xD;
             to the local anesthesia administration.&#xD;
  &#xD;
        Researchers will compare Tramadol, Naproxen sodium and Placebo to evaluate their effects on&#xD;
        Inferior alveolar nerve block efficacy and Postoperative pain.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The adult participants who report in out-patient department (OPD) of Operative Dentistry at&#xD;
        Dow International Dental College with the symptoms of irreversible pulpitis will be screened&#xD;
        for the participation in the study. A detailed history will be taken which will be followed&#xD;
        by clinical examination and complemented with sensibility testing with Endo Ice or electric&#xD;
        pulp test. Radiographic analysis will also be done to confirm the diagnosis to assess for&#xD;
        factors pertaining to exclusion and inclusion criteria. Verbal and written informed consent&#xD;
        will be taken from all the participants.&#xD;
  &#xD;
        Randomization: The participants will be randomly divided into 3 groups by envelope method.&#xD;
  &#xD;
        Group A will receive premedication of Oral tramadol 100mg, Group B will receive premedication&#xD;
        of oral naproxen 550mg. Both medicines will be given 60 minutes prior to the local anesthesia&#xD;
        administration. The third group, Group C, will be the control group and no active&#xD;
        preoperative medication will be given to these participants. A placebo will be given to these&#xD;
        participants. These medications will be given as a single intervention only.&#xD;
  &#xD;
        Blinding: Clinician and participants both will be blind to the medicine given to the&#xD;
        participants. Participants will be allowed to pick envelopes and a paramedical staff will be&#xD;
        trained in giving medication to the participants.&#xD;
  &#xD;
        Pain scores will be recorded by asking the participant to rate their pain on a scale ranging&#xD;
        from 0 to 10 before medication and then after 15 minutes, 30 minutes and 60 minutes of&#xD;
        administering the premedication. Pain score will also be recorded after 10 minutes of the&#xD;
        administration of Inferior alveolar nerve block (IANBs) and buccal nerve block &amp; during&#xD;
        deroofing process of chamber opening.&#xD;
  &#xD;
        Two cartridges of Lidocaine 1.8 ml having a concentration of 1:100,000 of Epinephrine will be&#xD;
        used for administration of regional anesthesia. Access opening will be performed under rubber&#xD;
        dam isolation with a Mani number 245 bur in a high-speed hand piece with copious water&#xD;
        irrigation. Sodium hypochlorite (5.25%) will be used as a standard root canal irrigation&#xD;
        solution.Pulpectomy will be performed with Mani K-files (8-25) till respective working&#xD;
        lengths of the teeth under study.&#xD;
  &#xD;
        To assess the post-operative pain, a proforma and pain intensity scale will be provided to&#xD;
        the participants for self recording at 6, 24, 48 and 72 hours after the procedure. The&#xD;
        participants will return the proforma to an intern on 3rd day to be assessed by an intern&#xD;
        supervised by the principal investigator.&#xD;
  &#xD;
        (For this research, &quot;The investigators will be offering As per need analgesic for&#xD;
        breakthrough pain. Participants will be offered brufen 400mg as needed. The participants will&#xD;
        be advised to mark breakthrough pain on VAS at the time of taking medicine).&#xD;
  &#xD;
        The participants will also be monitored for the adverse effects of these medications (nausea,&#xD;
        vomiting, dizziness, drowsiness) as a secondary outcome .at above-mentioned time-intervals.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">March 1, 2023</start_date>
    <completion_date type="Actual">August 15, 2023</completion_date>
    <primary_completion_date type="Actual">August 15, 2023</primary_completion_date>
    <phase>Phase 2/Phase 3</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>The participants will be randomly divided into 3 groups by envelope method. Group A will receive premedication of Oral tramadol 100mg, Group B will receive premedication of oral naproxen sodium 550mg. Both medicines will be given 60 minutes prior to the local anesthesia administration. The third group, Group C, will be the control group and no active preoperative medication will be given to these participants. A placebo will be given to these participants. These medications will be given as a single intervention only.</intervention_model_description>
      <primary_purpose>Prevention</primary_purpose>
      <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
      <masking_description>Clinician and participants both will be blind to the medicine given to the participants. Participants will be allowed to pick envelopes and a paramedical staff will be trained in giving medication to the participants. Procedure will be performed by an intern (who is not part of the research)Investigator is the Outcome Assessor.</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Local Anesthesia Efficacy</measure>
      <time_frame>10minutes,20minutes</time_frame>
      <description>Change in pain will be assessed after administration of inferior alveolar nerve block and during access opening on a visual analogue scale of 0-10 ,&quot; 0 being no pain&quot;, &quot;10 being worst pain&quot;</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Postoperative pain</measure>
      <time_frame>6 hours, 24 hours,48 hours, 72hours</time_frame>
      <description>Change in pain will be assessed after cleaning and shaping till #25 k file on a visual analogue scale of 0-10, &quot;0 being no pain and 10 being worst pain&quot;</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Adverse effects of Medications</measure>
      <time_frame>6hours, 24hours</time_frame>
      <description>Nausea, Headache, Dizziness, Vertigo will be recorded as experienced or not experienced</description>
    </secondary_outcome>
    <number_of_arms>3</number_of_arms>
    <enrollment type="Actual">47</enrollment>
    <condition>Symptomatic Irreversible Pulpitis</condition>
    <condition>Post Operative Pain</condition>
    <arm_group>
      <arm_group_label>Tramadol</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Group A will receive premedication of Oral tramadol 100mg,</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Naproxen Sodium</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Group B will receive premedication of oral naproxen sodium 550mg.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Placebo</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
      <description>Group C, will be the control group and no active preoperative medication will be given to these patients.</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Tramadol</intervention_name>
      <description>Tramadol 100mg will be given 60 minutes before start of procedure.</description>
      <arm_group_label>Tramadol</arm_group_label>
      <other_name>Tramal tablet</other_name>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Naproxen Sodium</intervention_name>
      <description>Naproxen sodium 550mg will be given 60 minutes before start of procedure.</description>
      <arm_group_label>Naproxen Sodium</arm_group_label>
      <other_name>Synflex 550mg</other_name>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Placebo</intervention_name>
      <description>Placebo will be given 60 minutes before start of procedure.</description>
      <arm_group_label>Placebo</arm_group_label>
      <other_name>Surbex Z</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  ASA I and ASA II individuals who are between the ages of 18 and 60 years.&#xD;
  &#xD;
            -  Patients who have been diagnosed with symptomatic irreversible pulpitis (with either a&#xD;
               normal periapex or symptomatic apical periodontitis).&#xD;
  &#xD;
            -  Patients who score moderate to severe (4-10) on a preoperative visual analogue scale&#xD;
               (VAS= 1-10).&#xD;
  &#xD;
            -  Mandibular permanent premolar and molars.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Patients who had taken painkillers or narcotics in the previous 12 hours&#xD;
  &#xD;
            -  Patients suffering from severe pain because of traumatic occlusion.&#xD;
  &#xD;
            -  Teeth with extensive damage, calcified canals, root resorption, and an open apex.&#xD;
  &#xD;
            -  Previously root canal treated teeth.&#xD;
  &#xD;
            -  Medically compromised patients (ASA-III and above)&#xD;
  &#xD;
            -  Those with special communication needs or who do not understand Urdu or English&#xD;
               language.&#xD;
  &#xD;
            -  Pregnant and lactating women&#xD;
  &#xD;
            -  Individual patients who will be driving back alone&#xD;
  &#xD;
            -  Patients who are allergic to the prescribed medicines&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>60 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Tayyaba Tahira, BDS FCPS</last_name>
      <role>Principal Investigator</role>
      <affiliation>Dow International Dental College, Dow University of Health Sciences</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Farah Naz, BDS FCPS</last_name>
      <role>Study Director</role>
      <affiliation>Dow International Dental College, Dow University of Health Sciences</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Dow International Dental College</name>
        <address>
          <city>Karachi</city>
          <state>Sindh</state>
          <zip>75500</zip>
          <country>Pakistan</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Pakistan</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>July 19, 2023</study_first_submitted>
    <study_first_submitted_qc>August 5, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 8, 2023</study_first_posted>
    <last_update_submitted>September 3, 2023</last_update_submitted>
    <last_update_submitted_qc>September 3, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 6, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Dow University of Health Sciences</investigator_affiliation>
      <investigator_full_name>Tayyaba Tahira</investigator_full_name>
      <investigator_title>Lecturer</investigator_title>
    </responsible_party>
    <keyword>Tramadol</keyword>
    <keyword>Naproxen Sodium</keyword>
    <keyword>Placebo</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Pulpitis</mesh_term>
      <mesh_term>Pain, Postoperative</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Naproxen</mesh_term>
      <mesh_term>Tramadol</mesh_term>
    </intervention_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
      <ipd_description>Only investigators and co-investigators of this study will be able to access to participants' personal data.&#xD;
  Ownership of the data will remain with the principal investigator and Department of Operative Dentistry, Dow International Dental College</ipd_description>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05982392
  org study id: 2889
  nct id: NCT05982392
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  is us export: No
  The goal of this clinical trial is to compare in Tramadol, Naproxen sodium and Placebo in
        participants presenting with irreversible pulpitis in their mandibular posterior teeth.
  
        The main question[s] it aims to answer are:
  
          -  Local anesthetic efficacy and .
  
          -  Postoperative pain. Participants will receive premedication treatments 60 minutes prior
             to the local anesthesia administration.
  
        Researchers will compare Tramadol, Naproxen sodium and Placebo to evaluate their effects on
        Inferior alveolar nerve block efficacy and Postoperative pain.
  The adult participants who report in out-patient department (OPD) of Operative Dentistry at
        Dow International Dental College with the symptoms of irreversible pulpitis will be screened
        for the participation in the study. A detailed history will be taken which will be followed
        by clinical examination and complemented with sensibility testing with Endo Ice or electric
        pulp test. Radiographic analysis will also be done to confirm the diagnosis to assess for
        factors pertaining to exclusion and inclusion criteria. Verbal and written informed consent
        will be taken from all the participants.
  
        Randomization: The participants will be randomly divided into 3 groups by envelope method.
  
        Group A will receive premedication of Oral tramadol 100mg, Group B will receive premedication
        of oral naproxen 550mg. Both medicines will be given 60 minutes prior to the local anesthesia
        administration. The third group, Group C, will be the control group and no active
        preoperative medication will be given to these participants. A placebo will be given to these
        participants. These medications will be given as a single intervention only.
  
        Blinding: Clinician and participants both will be blind to the medicine given to the
        participants. Participants will be allowed to pick envelopes and a paramedical staff will be
        trained in giving medication to the participants.
  
        Pain scores will be recorded by asking the participant to rate their pain on a scale ranging
        from 0 to 10 before medication and then after 15 minutes, 30 minutes and 60 minutes of
        administering the premedication. Pain score will also be recorded after 10 minutes of the
        administration of Inferior alveolar nerve block (IANBs) and buccal nerve block & during
        deroofing process of chamber opening.
  
        Two cartridges of Lidocaine 1.8 ml having a concentration of 1:100,000 of Epinephrine will be
        used for administration of regional anesthesia. Access opening will be performed under rubber
        dam isolation with a Mani number 245 bur in a high-speed hand piece with copious water
        irrigation. Sodium hypochlorite (5.25%) will be used as a standard root canal irrigation
        solution.Pulpectomy will be performed with Mani K-files (8-25) till respective working
        lengths of the teeth under study.
  
        To assess the post-operative pain, a proforma and pain intensity scale will be provided to
        the participants for self recording at 6, 24, 48 and 72 hours after the procedure. The
        participants will return the proforma to an intern on 3rd day to be assessed by an intern
        supervised by the principal investigator.
  
        (For this research, "The investigators will be offering As per need analgesic for
        breakthrough pain. Participants will be offered brufen 400mg as needed. The participants will
        be advised to mark breakthrough pain on VAS at the time of taking medicine).
  
        The participants will also be monitored for the adverse effects of these medications (nausea,
        vomiting, dizziness, drowsiness) as a secondary outcome .at above-mentioned time-intervals.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: The participants will be randomly divided into 3 groups by envelope method. Group A will receive premedication of Oral tramadol 100mg, Group B will receive premedication of oral naproxen sodium 550mg. Both medicines will be given 60 minutes prior to the local anesthesia administration. The third group, Group C, will be the control group and no active preoperative medication will be given to these participants. A placebo will be given to these participants. These medications will be given as a single intervention only.
  primary purpose: Prevention
  masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  masking description: Clinician and participants both will be blind to the medicine given to the participants. Participants will be allowed to pick envelopes and a paramedical staff will be trained in giving medication to the participants. Procedure will be performed by an intern (who is not part of the research)Investigator is the Outcome Assessor.
  measure: Local Anesthesia Efficacy
  time frame: 10minutes,20minutes
  description: Change in pain will be assessed after administration of inferior alveolar nerve block and during access opening on a visual analogue scale of 0-10 ," 0 being no pain", "10 being worst pain"
  measure: Postoperative pain
  time frame: 6 hours, 24 hours,48 hours, 72hours
  description: Change in pain will be assessed after cleaning and shaping till #25 k file on a visual analogue scale of 0-10, "0 being no pain and 10 being worst pain"
  measure: Adverse effects of Medications
  time frame: 6hours, 24hours
  description: Nausea, Headache, Dizziness, Vertigo will be recorded as experienced or not experienced
  arm group label: Tramadol
  arm group type: Active Comparator
  description: Group A will receive premedication of Oral tramadol 100mg,
  arm group label: Naproxen Sodium
  arm group type: Active Comparator
  description: Group B will receive premedication of oral naproxen sodium 550mg.
  arm group label: Placebo
  arm group type: Placebo Comparator
  description: Group C, will be the control group and no active preoperative medication will be given to these patients.
  intervention type: Drug
  intervention name: Tramadol
  description: Tramadol 100mg will be given 60 minutes before start of procedure.
  arm group label: Tramadol
  other name: Tramal tablet
  intervention type: Drug
  intervention name: Naproxen Sodium
  description: Naproxen sodium 550mg will be given 60 minutes before start of procedure.
  arm group label: Naproxen Sodium
  other name: Synflex 550mg
  intervention type: Drug
  intervention name: Placebo
  description: Placebo will be given 60 minutes before start of procedure.
  arm group label: Placebo
  other name: Surbex Z
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 60 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Tayyaba Tahira, BDS FCPS
  role: Principal Investigator
  affiliation: Dow International Dental College, Dow University of Health Sciences
  last name: Farah Naz, BDS FCPS
  role: Study Director
  affiliation: Dow International Dental College, Dow University of Health Sciences
  facility: 
  country: Pakistan
  responsible party type: Principal Investigator
  investigator affiliation: Dow University of Health Sciences
  investigator full name: Tayyaba Tahira
  investigator title: Lecturer
  mesh term: Pulpitis
  mesh term: Pain, Postoperative
  mesh term: Naproxen
  mesh term: Tramadol
  sharing ipd: No
  ipd description: Only investigators and co-investigators of this study will be able to access to participants' personal data.
  Ownership of the data will remain with the principal investigator and Department of Operative Dentistry, Dow International Dental College