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/NCT05979558</url>
    </required_header>
    <id_info>
      <org_study_id>NamsNepal</org_study_id>
      <nct_id>NCT05979558</nct_id>
    </id_info>
    <brief_title>Caudal Ropivacaine With or Without Dexmedetomidine for Post Operative Analgesia</brief_title>
    <official_title>Study of Caudal Ropivacaine With or Without Dexmedetomidine for Postoperative Analgesia in Pediatric Infra-umbilical Surgery: A Double-blinded Randomized Control Trial</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>National Academy of Medical Sciences, Nepal</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>National Academy of Medical Sciences, Nepal</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 evaluate the postoperative analgesic effects of caudal&#xD;
        Ropivacaine with or without Dexmedetomidine in pediatric infraumbilical surgery. The main&#xD;
        question[s] it aims to answer are:&#xD;
  &#xD;
        • if Caudal Dexmedetomidine with Ropivacaine would prolong the duration of analgesia in&#xD;
        children undergoing infraumbilical surgery.&#xD;
  &#xD;
        Participants will receive ropivacaine with dexmedetomidine in infraumbilical surgery.&#xD;
  &#xD;
        If there is a comparison group: Investigators will compare this with ropivacaine with a&#xD;
        placebo to see if the duration of analgesia differs.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Children have significant pain following surgery. It has been under-managed most of the time.&#xD;
        Poorly controlled post-operative pain increases the morbidity. It leads to post-operative&#xD;
        agitation, urinary retention, nausea and vomiting, hypoxia, pulmonary edema, cardiovascular&#xD;
        and temperature instability. So, postoperative pain management is an essential and important&#xD;
        component of pediatric postoperative care. Adequate pain control after surgery permits early&#xD;
        mobilization, reduces postoperative complication, prevents development of fear and anxiety&#xD;
        and allows early hospital discharge.&#xD;
  &#xD;
        Caudal block is one of the modality of multimodal analgesia. It is a well-established,&#xD;
        effective and relatively safe technique used for intra and post-operative analgesia in&#xD;
        children undergoing abdominal and lower limb surgery. It provides excellent analgesia,&#xD;
        reduces intra-operative anesthetics drug requirements, ensures pain free recovery from&#xD;
        anesthesia, decreases stress response and avoids deleterious adverse effects of narcotic&#xD;
        drugs.&#xD;
  &#xD;
        However, the main disadvantage of caudal block is being its short duration of action with&#xD;
        sole local anesthetics. Even long-acting local anesthetic drugs such as bupivacaine provides&#xD;
        only 4-8 hours of analgesia. The insertion of catheter in caudal space to administer repeated&#xD;
        doses or continuous infusions of local anesthetic drug is not popular because of concerns of&#xD;
        infection. So, various adjuvants like Fentanyl, Morphine, Ketamine, clonidine,&#xD;
        Dexmeditomidine etc. have been used to prolong the duration of analgesia.&#xD;
  &#xD;
        Morphine and Fentanyl are opioids that have been used traditionally in combination with a&#xD;
        local anesthetic to achieve prolonged anesthetic effect. The addition of opioid does provide&#xD;
        better analgesia but there is a possibility of an increased incidence of pruritus, urinary&#xD;
        retention, nausea, vomiting and respiratory depression. Similarly, Ketamine and Clonidine are&#xD;
        the widely preferred adjuvant to caudal block but have their own number of unpleasant adverse&#xD;
        effects8.&#xD;
  &#xD;
        Hence, there is still ongoing investigations to find for an adjuvant that can safely prolong&#xD;
        caudal analgesia. Recently, Dexmedetomidine has been used for this purpose. Various studies&#xD;
        have described the use of Dexmedetomidine with local anesthetic drugs in caudal block for the&#xD;
        management of postoperative pain in children. Saadawy et al. found that 1μg/kg caudal&#xD;
        dexmedetomidine with bupivacaine was associated with an extended duration of postoperative&#xD;
        analgesia while in other studies 2μg/kg Dexmedetomidine was used with caudal Bupivacaine or&#xD;
        Ropivacaine for providing postoperative analgesia in children undergoing lower abdominal and&#xD;
        perineal surgeries.&#xD;
  &#xD;
        Dexmedetomidine is a highly specific and selective α2-adrenoceptor agonist that has been&#xD;
        described as a safe and effective additive in many anesthetic procedures. In contrast to&#xD;
        other agents, it has a sympatholytic, analgesic and sedative effects. It is remarkably free&#xD;
        from side effects except for hypotension and bradycardia. But studies investigating its&#xD;
        analgesic property in our population are limited.&#xD;
  &#xD;
        Ropivacaine is a long-acting amino amide local anesthetic drug and was the first to be&#xD;
        formulated as a pure S-enantiomer. It is reported to have a better safety profile than&#xD;
        Bupivacaine with less risk for central nervous system and cardiac toxicity 10. It also&#xD;
        decreases unwanted motor block than Bupivacaine, which makes it a more suitable agent for&#xD;
        caudal epidural analgesia6.&#xD;
  &#xD;
        Dexmedetomidine with Ropivacaine is commonly used to prolong the caudal analgesia in western&#xD;
        population but have not been well studied in our pediatric population. So investigators&#xD;
        designed this study to determine analgesic effect of caudal Dexmedetomidine with Ropivacaine&#xD;
        in pediatric infraumbilical surgeries.&#xD;
  &#xD;
        HYPOTHESIS Caudal Dexmedetomidine with Ropivacaine would not prolong the duration of&#xD;
        analgesia in children undergoing infraumbilical surgery.&#xD;
  &#xD;
        GENERAL OBJECTIVES To evaluate the postoperative analgesic effects of caudal Ropivacaine with&#xD;
        or without Dexmedetomidine in pediatric infraumbilical surgery SPECIFIC OBJECTIVES&#xD;
  &#xD;
          1. To compare rFLACC score (revised Face, Legs, Activity, Cry, and Consolability)in 24&#xD;
             hours of postoperative period.&#xD;
  &#xD;
          2. To compare the time for first rescue analgesia.&#xD;
  &#xD;
          3. To evaluate the total analgesics consumption in 24 hours of postoperative period.&#xD;
  &#xD;
          4. To observe the side effects of study drugs (vomiting and bradycardia).&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">June 16, 2020</start_date>
    <completion_date type="Actual">December 10, 2021</completion_date>
    <primary_completion_date type="Actual">June 10, 2021</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>Children were randomly assigned to two groups having 31 children in each, by using a computer-generated table of random numbers which was enclosed in a sealed envelope and was opened by an anesthesiologist who were not involved in the study.</intervention_model_description>
      <primary_purpose>Supportive Care</primary_purpose>
      <masking>Double (Participant, Care Provider)</masking>
      <masking_description>Children were randomly assigned to two groups having 31 children in each, by using a computer-generated table of random numbers which was enclosed in a sealed envelope and was opened by an anesthesiologist who were not involved in the study.</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Duration of analgesia:</measure>
      <time_frame>upto first 24 hour after intervention</time_frame>
      <description>The primary outcome will be the duration of analgesia defined as the time period between administration of study drugs to first need of rescue analgesia when until the time of rFLACC score (revised Face, Legs, Activity, Cry, and Consolability) reached ≥4.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Post-operative pain Assessment (rFLACC score) rFLACC score (revised Face, Legs, Activity, Cry, and Consolability)</measure>
      <time_frame>first 24 hour after intervention</time_frame>
      <description>Each of the five categories F (face), L (legs), A (Activity), C (Cry), C (Consolability) will be scored from 0 to 2 which results total score in between zero and ten.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Total analgesics consumption in first 24 hours postoperative period</measure>
      <time_frame>first 24 hours after intervention</time_frame>
      <description>If r-FLACC pain score ≥4 at any time, an injection Paracetamol 15mg/kg will be given. If the r-FLACC pain score still ≥4 after 30 minutes of injection Paracetamol, then the child will treated with an injection Pethidine 0.5mg/kg. After that, an injection Paracetamol at 15mg/kg will be given 6 hourly. Total analgesic consumption in the first 24 hours will be calculated by adding the total analgesic consumed in 24 hours after the intervention.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Side effects of study drugs</measure>
      <time_frame>monitored for 24 hours and treated accordingly</time_frame>
      <description>Adverse events such as nausea, vomiting, bradycardia, respiratory depression and urinary retention will be monitored for 24 hours and treated accordingly</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Actual">62</enrollment>
    <condition>Ropivacaine</condition>
    <condition>Infraumbilical Surgery</condition>
    <condition>Dexmedetomidine</condition>
    <condition>Analgesia</condition>
    <arm_group>
      <arm_group_label>Ropivacaine with dexmedetomidine</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <arm_group>
      <arm_group_label>Ropivacaine with Normal Saline</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>ropivacaine with dexmedetomidine</intervention_name>
      <description>this group received with ropivacaine with dexmedetomidine</description>
      <arm_group_label>Ropivacaine with dexmedetomidine</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Ropivacaine with placebo</intervention_name>
      <description>this group received with ropivacaine with normal saline</description>
      <arm_group_label>Ropivacaine with Normal Saline</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Children of either sex aged 2-7 years&#xD;
  &#xD;
            -  ASA (American Society of Anesthesiologist) physical status I or II&#xD;
  &#xD;
            -  Patients undergoing elective infraumbilical surgeries&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  History of neuromuscular or psychiatric disease&#xD;
  &#xD;
            -  Coagulation disorders&#xD;
  &#xD;
            -  Skin lesion at the site of injection&#xD;
  &#xD;
            -  Spine deformity&#xD;
  &#xD;
            -  History of developmental delay&#xD;
  &#xD;
            -  Allergy to study drugs&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>2 Years</minimum_age>
      <maximum_age>7 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Kaushal Tamang, MBBS,MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>NAMS</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Bidur K Baral, MBBS,MD</last_name>
      <role>Study Chair</role>
      <affiliation>NAMS</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Sadichhya S Malla, MBBS,MD</last_name>
      <role>Study Chair</role>
      <affiliation>Kanti Hospital</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>National Academy of Medical Sciences (NAMS)</name>
        <address>
          <city>Kathmandu</city>
          <state>Bagmati</state>
          <zip>44600</zip>
          <country>Nepal</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Nepal</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 21, 2023</study_first_submitted>
    <study_first_submitted_qc>July 29, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 7, 2023</study_first_posted>
    <last_update_submitted>July 29, 2023</last_update_submitted>
    <last_update_submitted_qc>July 29, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 7, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>National Academy of Medical Sciences, Nepal</investigator_affiliation>
      <investigator_full_name>Kaushal Tamang</investigator_full_name>
      <investigator_title>Principal Investigator</investigator_title>
    </responsible_party>
    <keyword>ropivacaine</keyword>
    <keyword>caudal ropivacaine</keyword>
    <keyword>dexmedetomidine</keyword>
    <keyword>placebo</keyword>
    <keyword>analgesia</keyword>
    <keyword>infraumbilical surgery</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Agnosia</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Dexmedetomidine</mesh_term>
      <mesh_term>Ropivacaine</mesh_term>
    </intervention_browse>
    <!-- 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/NCT05979558
  org study id: NamsNepal
  nct id: NCT05979558
  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 evaluate the postoperative analgesic effects of caudal
        Ropivacaine with or without Dexmedetomidine in pediatric infraumbilical surgery. The main
        question[s] it aims to answer are:
  
        • if Caudal Dexmedetomidine with Ropivacaine would prolong the duration of analgesia in
        children undergoing infraumbilical surgery.
  
        Participants will receive ropivacaine with dexmedetomidine in infraumbilical surgery.
  
        If there is a comparison group: Investigators will compare this with ropivacaine with a
        placebo to see if the duration of analgesia differs.
  Children have significant pain following surgery. It has been under-managed most of the time.
        Poorly controlled post-operative pain increases the morbidity. It leads to post-operative
        agitation, urinary retention, nausea and vomiting, hypoxia, pulmonary edema, cardiovascular
        and temperature instability. So, postoperative pain management is an essential and important
        component of pediatric postoperative care. Adequate pain control after surgery permits early
        mobilization, reduces postoperative complication, prevents development of fear and anxiety
        and allows early hospital discharge.
  
        Caudal block is one of the modality of multimodal analgesia. It is a well-established,
        effective and relatively safe technique used for intra and post-operative analgesia in
        children undergoing abdominal and lower limb surgery. It provides excellent analgesia,
        reduces intra-operative anesthetics drug requirements, ensures pain free recovery from
        anesthesia, decreases stress response and avoids deleterious adverse effects of narcotic
        drugs.
  
        However, the main disadvantage of caudal block is being its short duration of action with
        sole local anesthetics. Even long-acting local anesthetic drugs such as bupivacaine provides
        only 4-8 hours of analgesia. The insertion of catheter in caudal space to administer repeated
        doses or continuous infusions of local anesthetic drug is not popular because of concerns of
        infection. So, various adjuvants like Fentanyl, Morphine, Ketamine, clonidine,
        Dexmeditomidine etc. have been used to prolong the duration of analgesia.
  
        Morphine and Fentanyl are opioids that have been used traditionally in combination with a
        local anesthetic to achieve prolonged anesthetic effect. The addition of opioid does provide
        better analgesia but there is a possibility of an increased incidence of pruritus, urinary
        retention, nausea, vomiting and respiratory depression. Similarly, Ketamine and Clonidine are
        the widely preferred adjuvant to caudal block but have their own number of unpleasant adverse
        effects8.
  
        Hence, there is still ongoing investigations to find for an adjuvant that can safely prolong
        caudal analgesia. Recently, Dexmedetomidine has been used for this purpose. Various studies
        have described the use of Dexmedetomidine with local anesthetic drugs in caudal block for the
        management of postoperative pain in children. Saadawy et al. found that 1μg/kg caudal
        dexmedetomidine with bupivacaine was associated with an extended duration of postoperative
        analgesia while in other studies 2μg/kg Dexmedetomidine was used with caudal Bupivacaine or
        Ropivacaine for providing postoperative analgesia in children undergoing lower abdominal and
        perineal surgeries.
  
        Dexmedetomidine is a highly specific and selective α2-adrenoceptor agonist that has been
        described as a safe and effective additive in many anesthetic procedures. In contrast to
        other agents, it has a sympatholytic, analgesic and sedative effects. It is remarkably free
        from side effects except for hypotension and bradycardia. But studies investigating its
        analgesic property in our population are limited.
  
        Ropivacaine is a long-acting amino amide local anesthetic drug and was the first to be
        formulated as a pure S-enantiomer. It is reported to have a better safety profile than
        Bupivacaine with less risk for central nervous system and cardiac toxicity 10. It also
        decreases unwanted motor block than Bupivacaine, which makes it a more suitable agent for
        caudal epidural analgesia6.
  
        Dexmedetomidine with Ropivacaine is commonly used to prolong the caudal analgesia in western
        population but have not been well studied in our pediatric population. So investigators
        designed this study to determine analgesic effect of caudal Dexmedetomidine with Ropivacaine
        in pediatric infraumbilical surgeries.
  
        HYPOTHESIS Caudal Dexmedetomidine with Ropivacaine would not prolong the duration of
        analgesia in children undergoing infraumbilical surgery.
  
        GENERAL OBJECTIVES To evaluate the postoperative analgesic effects of caudal Ropivacaine with
        or without Dexmedetomidine in pediatric infraumbilical surgery SPECIFIC OBJECTIVES
  
          1. To compare rFLACC score (revised Face, Legs, Activity, Cry, and Consolability)in 24
             hours of postoperative period.
  
          2. To compare the time for first rescue analgesia.
  
          3. To evaluate the total analgesics consumption in 24 hours of postoperative period.
  
          4. To observe the side effects of study drugs (vomiting and bradycardia).
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: Children were randomly assigned to two groups having 31 children in each, by using a computer-generated table of random numbers which was enclosed in a sealed envelope and was opened by an anesthesiologist who were not involved in the study.
  primary purpose: Supportive Care
  masking: Double (Participant, Care Provider)
  masking description: Children were randomly assigned to two groups having 31 children in each, by using a computer-generated table of random numbers which was enclosed in a sealed envelope and was opened by an anesthesiologist who were not involved in the study.
  measure: Duration of analgesia:
  time frame: upto first 24 hour after intervention
  description: The primary outcome will be the duration of analgesia defined as the time period between administration of study drugs to first need of rescue analgesia when until the time of rFLACC score (revised Face, Legs, Activity, Cry, and Consolability) reached ≥4.
  measure: Post-operative pain Assessment (rFLACC score) rFLACC score (revised Face, Legs, Activity, Cry, and Consolability)
  time frame: first 24 hour after intervention
  description: Each of the five categories F (face), L (legs), A (Activity), C (Cry), C (Consolability) will be scored from 0 to 2 which results total score in between zero and ten.
  measure: Total analgesics consumption in first 24 hours postoperative period
  time frame: first 24 hours after intervention
  description: If r-FLACC pain score ≥4 at any time, an injection Paracetamol 15mg/kg will be given. If the r-FLACC pain score still ≥4 after 30 minutes of injection Paracetamol, then the child will treated with an injection Pethidine 0.5mg/kg. After that, an injection Paracetamol at 15mg/kg will be given 6 hourly. Total analgesic consumption in the first 24 hours will be calculated by adding the total analgesic consumed in 24 hours after the intervention.
  measure: Side effects of study drugs
  time frame: monitored for 24 hours and treated accordingly
  description: Adverse events such as nausea, vomiting, bradycardia, respiratory depression and urinary retention will be monitored for 24 hours and treated accordingly
  arm group label: Ropivacaine with dexmedetomidine
  arm group type: Experimental
  arm group label: Ropivacaine with Normal Saline
  arm group type: Placebo Comparator
  intervention type: Drug
  intervention name: ropivacaine with dexmedetomidine
  description: this group received with ropivacaine with dexmedetomidine
  arm group label: Ropivacaine with dexmedetomidine
  intervention type: Drug
  intervention name: Ropivacaine with placebo
  description: this group received with ropivacaine with normal saline
  arm group label: Ropivacaine with Normal Saline
  criteria: 
  gender: All
  minimum age: 2 Years
  maximum age: 7 Years
  healthy volunteers: No
  last name: Kaushal Tamang, MBBS,MD
  role: Principal Investigator
  affiliation: NAMS
  last name: Bidur K Baral, MBBS,MD
  role: Study Chair
  affiliation: NAMS
  last name: Sadichhya S Malla, MBBS,MD
  role: Study Chair
  affiliation: Kanti Hospital
  facility: 
  country: Nepal
  responsible party type: Principal Investigator
  investigator affiliation: National Academy of Medical Sciences, Nepal
  investigator full name: Kaushal Tamang
  investigator title: Principal Investigator
  mesh term: Agnosia
  mesh term: Dexmedetomidine
  mesh term: Ropivacaine