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/NCT05999890</url>
    </required_header>
    <id_info>
      <org_study_id>KIMS/IEC/A035/D/2021</org_study_id>
      <nct_id>NCT05999890</nct_id>
      <nct_alias>NCT05967221</nct_alias>
    </id_info>
    <brief_title>Comparison of Postoperative Analgesia Between Intravenous Paracetamol and Intranasal Tapentadol</brief_title>
    <official_title>A Comparative Study Between Intranasal Tapentadol Versus Intravenous Paracetamol for Post-operative Analgesia in Lower Limb Orthopedic Surgeries Under Spinal Anaesthesia'</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Kempegowda Institute of Medical Sciences, Bangalore</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Kempegowda Institute of Medical Sciences, Bangalore</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 aim of the study was to compare the analgesic efficacy of intranasal tapentadol nasal&#xD;
        spray 44.5mg and intravenous paracetamol 1gm during the postoperative period by Visual analog&#xD;
        scale(VAS)in patients undergoing lower limb(long bone fractures)orthopedic surgeries.&#xD;
        Paracetamol is one of the most frequently used analgesic and antipyretic agents, interferes&#xD;
        neither with platelet nor kidney functions nor does it present the unwanted side effects of&#xD;
        NSAIDs. Tapentadol is a novel, centrally-acting analgesic with a dual mechanism of action,&#xD;
        combining mu-opioid receptor agonism with norepinephrine reuptake inhibition. This dual mode&#xD;
        of action is responsible for its opioid-sparing effect, which contributes to a reduction in&#xD;
        some of the typical opioid-related adverse effects&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Inclusion criteria Age: From 18.00 Year(s) to 60.00 years Gender: Both American Society of&#xD;
        Anesthesiologists (ASA) physical status: 1 &amp; 2, posted for elective lower limb orthopedic&#xD;
        surgeries Exclusion criteria&#xD;
  &#xD;
          1. Sepsis at the site of injection&#xD;
  &#xD;
          2. Coagulopathy&#xD;
  &#xD;
          3. Patients with history of renal, hepatic, cardiovascular disease&#xD;
  &#xD;
          4. Patient on chronic opioid use Outcome Comparing postoperative analgesia between the&#xD;
             groups every 12 hours after the intervention till about 72 hours post intervention. The&#xD;
             secondary outcome is to compare the need for the rescue analgesia between the groups&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">July 5, 2021</start_date>
    <completion_date type="Actual">December 30, 2021</completion_date>
    <primary_completion_date type="Actual">December 30, 2021</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>
      <intervention_model_description>It is a single blind randomized controlled trial comparing the intranasal tapentadol with intravenous paracetamol for post operative analgesia</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Single (Outcomes Assessor)</masking>
      <masking_description>Single (Outcomes Assessor) The assessor of the outcome would measure hemodynamic parameters and severity of the pain at the mentioned time intervals. The assessor was not involved in the randomization / administration of the intervention</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Pain as measured with Visual analogue scale</measure>
      <time_frame>Every 12 hours after the intervention till about 72 hours after the intervention</time_frame>
      <description>The pain rating was done as per a visual analogue scale (VAS) of 0-100 (score 0 = no pain, score 100 - most severe pain). Patients with a VAS score of more than 30, at what is considered as base line, in group A=received IV paracetamol 1gm given every 5-6 hourly and in group B=received intranasal tapentadol 44.5mg nasal spray administered every 5-6 hourly. Patient was assessed for pain by using VAS half an hour after administration and the scores were documented. Pain score were recorded at and after 30 minutes of the intervention in the following time frames - 12hr,24hr,36hr,48hr, 60hr and 72hrs after the baseline intervention (0hr).</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>The need for rescue analgesia</measure>
      <time_frame>In the first 72 hours after the initiation of the intervention</time_frame>
      <description>The need for the add on analgesic whenever the subjects request for the same</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Actual">74</enrollment>
    <condition>Lower Limb Fracture</condition>
    <arm_group>
      <arm_group_label>Tapentadol</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Tapentadol is a novel, centrally acting analgesic with dual mechanism of action, combining mu-opioid receptor agonism with norepinephrine reuptake inhibition.this dual mode of action is responsible for its opioid sparing effect, which contributes to reduction in some of the typical opioid related adverse effects</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Paracetamol</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Paracetamol is one of the most frequently used analgesic and antipyretic agent, interferes neither with platelet nor kidney functions nor does it present the unwanted side effects of NSAIDS.</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Tapentadol Hydrochloride</intervention_name>
      <description>Intranasal administration of tapentadol was compared with intravenous paracetamol for postoperative analgesia</description>
      <arm_group_label>Paracetamol</arm_group_label>
      <arm_group_label>Tapentadol</arm_group_label>
      <other_name>Paracetamol</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. American Society of Anesthesiologists (ASA) physical status 1 &amp; 2&#xD;
  &#xD;
            2. Posted for elective lower limb orthopaedic surgeries&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Sepsis at the site of injection&#xD;
  &#xD;
            2. Coagulopathy&#xD;
  &#xD;
            3. Patients with history of renal, hepatic, cardiovascular disease&#xD;
  &#xD;
            4. Patient on chronic opioid use&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>60 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>Kempegowda Institute of Medical Sciences</name>
        <address>
          <city>Bangalore</city>
          <state>Karnataka</state>
          <zip>560004</zip>
          <country>India</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>India</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 11, 2023</study_first_submitted>
    <study_first_submitted_qc>August 11, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 21, 2023</study_first_posted>
    <last_update_submitted>August 11, 2023</last_update_submitted>
    <last_update_submitted_qc>August 11, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 21, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Kempegowda Institute of Medical Sciences, Bangalore</investigator_affiliation>
      <investigator_full_name>Priyanka Suresh</investigator_full_name>
      <investigator_title>Assistant Professor</investigator_title>
    </responsible_party>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Tapentadol</mesh_term>
    </intervention_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
      <ipd_description>Individual patient data will not be shared; If needed only anonymised individual data will be shared</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/NCT05999890
  org study id: KIMS/IEC/A035/D/2021
  nct id: NCT05999890
  nct alias: NCT05967221
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The aim of the study was to compare the analgesic efficacy of intranasal tapentadol nasal
        spray 44.5mg and intravenous paracetamol 1gm during the postoperative period by Visual analog
        scale(VAS)in patients undergoing lower limb(long bone fractures)orthopedic surgeries.
        Paracetamol is one of the most frequently used analgesic and antipyretic agents, interferes
        neither with platelet nor kidney functions nor does it present the unwanted side effects of
        NSAIDs. Tapentadol is a novel, centrally-acting analgesic with a dual mechanism of action,
        combining mu-opioid receptor agonism with norepinephrine reuptake inhibition. This dual mode
        of action is responsible for its opioid-sparing effect, which contributes to a reduction in
        some of the typical opioid-related adverse effects
  Inclusion criteria Age: From 18.00 Year(s) to 60.00 years Gender: Both American Society of
        Anesthesiologists (ASA) physical status: 1 & 2, posted for elective lower limb orthopedic
        surgeries Exclusion criteria
  
          1. Sepsis at the site of injection
  
          2. Coagulopathy
  
          3. Patients with history of renal, hepatic, cardiovascular disease
  
          4. Patient on chronic opioid use Outcome Comparing postoperative analgesia between the
             groups every 12 hours after the intervention till about 72 hours post intervention. The
             secondary outcome is to compare the need for the rescue analgesia between the groups
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: It is a single blind randomized controlled trial comparing the intranasal tapentadol with intravenous paracetamol for post operative analgesia
  primary purpose: Treatment
  masking: Single (Outcomes Assessor)
  masking description: Single (Outcomes Assessor) The assessor of the outcome would measure hemodynamic parameters and severity of the pain at the mentioned time intervals. The assessor was not involved in the randomization / administration of the intervention
  measure: Pain as measured with Visual analogue scale
  time frame: Every 12 hours after the intervention till about 72 hours after the intervention
  description: The pain rating was done as per a visual analogue scale (VAS) of 0-100 (score 0 = no pain, score 100 - most severe pain). Patients with a VAS score of more than 30, at what is considered as base line, in group A=received IV paracetamol 1gm given every 5-6 hourly and in group B=received intranasal tapentadol 44.5mg nasal spray administered every 5-6 hourly. Patient was assessed for pain by using VAS half an hour after administration and the scores were documented. Pain score were recorded at and after 30 minutes of the intervention in the following time frames - 12hr,24hr,36hr,48hr, 60hr and 72hrs after the baseline intervention (0hr).
  measure: The need for rescue analgesia
  time frame: In the first 72 hours after the initiation of the intervention
  description: The need for the add on analgesic whenever the subjects request for the same
  arm group label: Tapentadol
  arm group type: Experimental
  description: Tapentadol is a novel, centrally acting analgesic with dual mechanism of action, combining mu-opioid receptor agonism with norepinephrine reuptake inhibition.this dual mode of action is responsible for its opioid sparing effect, which contributes to reduction in some of the typical opioid related adverse effects
  arm group label: Paracetamol
  arm group type: Active Comparator
  description: Paracetamol is one of the most frequently used analgesic and antipyretic agent, interferes neither with platelet nor kidney functions nor does it present the unwanted side effects of NSAIDS.
  intervention type: Drug
  intervention name: Tapentadol Hydrochloride
  description: Intranasal administration of tapentadol was compared with intravenous paracetamol for postoperative analgesia
  arm group label: Paracetamol
  arm group label: Tapentadol
  other name: Paracetamol
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 60 Years
  healthy volunteers: No
  facility: 
  country: India
  responsible party type: Principal Investigator
  investigator affiliation: Kempegowda Institute of Medical Sciences, Bangalore
  investigator full name: Priyanka Suresh
  investigator title: Assistant Professor
  mesh term: Tapentadol
  sharing ipd: No
  ipd description: Individual patient data will not be shared; If needed only anonymised individual data will be shared