<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/NCT01679353</url>
  </required_header>
  <id_info>
    <org_study_id>4-2012-0278</org_study_id>
    <nct_id>NCT01679353</nct_id>
  </id_info>
  <brief_title>Comparison of Analgesic Effect of Magnesium Added to Ropivacaine and Ropivacaine Alone in Caudal Analgesia on Postoperative Pain Control in Pediatric Patients Undergoing Inguinal Hernia Repair</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>Yonsei University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Yonsei University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      A caudal anesthesia is one of the most commonly used technique providing intra and&#xD;
      postoperative analgesia in pediatric low abdominal surgery. The practice of adding adjunct&#xD;
      analgesic drugs to local anesthetics for caudal block is common. The most commonly used drugs&#xD;
      are opioids, clonidine, and ketamine. However, their use has been limited by adverse effects&#xD;
      in children.&#xD;
&#xD;
      Recently, the importance of magnesium in analgesic effects has been increased. Magnesium is&#xD;
      the fourth most abundant cation in the body. It has antinociceptive effects in human and&#xD;
      these effects are primarily based on the regulation of calcium influx into the cell.&#xD;
      Magnesium is a physiological calcium antagonist and blocks N-methyl-D-aspartate (NMDA)&#xD;
      receptor and such NMDA antagonism prevents the central sensitization from nociceptive&#xD;
      stimulation. Many study suggested that epidurally administered magnesium could reduce the&#xD;
      postoperative pain in adults. But few studies are available about the use of magnesium in&#xD;
      pediatrics.&#xD;
&#xD;
      The investigators performed prospective randomized double-blind study to examine the&#xD;
      analgesic effect of magnesium added to ropivacaine and ropivacaine alone in caudal analgesia&#xD;
      on postoperative pain control in pediatric patients undergoing inguinal hernia repair.&#xD;
&#xD;
      80 children (aged 2- 6 yr) undergoing inguinal hernia repair were included in this&#xD;
      prospective, randomized, double-blinded study. After inhalation induction of general&#xD;
      anesthesia, caudal block was applied. Patients were randomly assigned in two groups. Normal&#xD;
      saline 0.5mL added to ropivacaine 0.15% 1.0 ml/kg was administered to Group R , Magnesium&#xD;
      50mg (Magnesium 10% 0.5mL)added to ropivacaine 0.15% 1.0ml/kg to Group MR. Postoperative pain&#xD;
      was recorded at 30min and 1,2,3 h by using Hospital of Eastern Ontario Pain Scale (CHEOPS,&#xD;
      0-10) and Faces Legs Activity Cry Consolability tool (FLACC, 0-10). Participants will be&#xD;
      followed for the duration of hospital stay, an expected average of 3 hours.&#xD;
&#xD;
      After discharge, rescue analgesic consumption, pain scores (Parents Postoperative Pain&#xD;
      Measurement, PPPM), and adverse effects were evaluated for 48h.&#xD;
&#xD;
      The time to first supplemental oral analgesic medication demand was defined as the time from&#xD;
      the end of surgery to the first registration of a PPPM( 0 - 15) ≥ 6 by parent's observation.&#xD;
      48 hours after surgery, reports of delayed side effects and demands for rescue analgesics&#xD;
      from the child were gathered from parents via a telephone interview.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>September 2012</start_date>
  <completion_date type="Actual">January 2013</completion_date>
  <primary_completion_date type="Actual">December 2012</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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The number of children who required analgesics</measure>
    <time_frame>at 24 and 48 hours after surgery</time_frame>
    <description>Primary outcome is defined as the number of patients who required analgesics after discharge. Postoperative pain at home is assessed by parent using the PPPM scale that consists of 15 questions requiring a &quot;yes&quot; or &quot;no&quot; answer (yes = 1 point and no = 0 point). A PPPM score ≥ 6 by parent's observation is considered to represent clinically significant pain, requiring analgesics.&#xD;
The PPPM is a 15-item observational checklist measure of pain intensity that was designed to be used by parents to support research and clinical postoperative care for children at home.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">80</enrollment>
  <condition>Inguinal Hernia</condition>
  <arm_group>
    <arm_group_label>placebo group</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>normal saline 0.5ml</description>
  </arm_group>
  <arm_group>
    <arm_group_label>magnesum group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>After inhalation induction of general anesthesia, caudal block was applied. Patients were randomly assigned in two groups. Normal saline 0.5mL added to ropivacaine 0.15% 1.0 ml/kg was administered to Group R , Magnesium 50mg (Magnesium 10% 0.5mL)added to ropivacaine 0.15% 1.0ml/kg to Group MR.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>caudal block</intervention_name>
    <description>After inhalation induction of general anesthesia, caudal block was applied. Patients were randomly assigned in two groups. Normal saline 0.5mL added to ropivacaine 0.15% 1.0 ml/kg was administered to Group R , Magnesium 50mg (Magnesium 10% 0.5mL)added to ropivacaine 0.15% 1.0ml/kg to Group MR.</description>
    <arm_group_label>magnesum group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>normal saline 0.5ml</intervention_name>
    <arm_group_label>placebo group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  ASA status I-II,&#xD;
&#xD;
          -  children aged 2 to 6 yr&#xD;
&#xD;
          -  weight under 20kg&#xD;
&#xD;
          -  undergoing inguinal hernia repair&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Hypersensitivity fo any local anesthetics,&#xD;
&#xD;
          -  bleeding diathesis, infections at puncture sites,&#xD;
&#xD;
          -  pre-existing neurological disease,&#xD;
&#xD;
          -  patients taking Calcium channel block,&#xD;
&#xD;
          -  patients taking opioid&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>2 Years</minimum_age>
    <maximum_age>6 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Severance hospital</name>
      <address>
        <city>Seoul</city>
        <zip>120-752</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <reference>
    <citation>Farouk S. Pre-incisional epidural magnesium provides pre-emptive and preventive analgesia in patients undergoing abdominal hysterectomy. Br J Anaesth. 2008 Nov;101(5):694-9. doi: 10.1093/bja/aen274. Epub 2008 Sep 26.</citation>
    <PMID>18820247</PMID>
  </reference>
  <verification_date>June 2014</verification_date>
  <study_first_submitted>August 27, 2012</study_first_submitted>
  <study_first_submitted_qc>September 2, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 6, 2012</study_first_posted>
  <last_update_submitted>June 10, 2014</last_update_submitted>
  <last_update_submitted_qc>June 10, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">June 12, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>inguinal hernia, caudal analgesia, magnesium</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hernia</mesh_term>
    <mesh_term>Hernia, Inguinal</mesh_term>
  </condition_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/NCT01679353
org study id: 4-2012-0278
nct id: NCT01679353
lead sponsor: 
has dmc: No
A caudal anesthesia is one of the most commonly used technique providing intra and
      postoperative analgesia in pediatric low abdominal surgery. The practice of adding adjunct
      analgesic drugs to local anesthetics for caudal block is common. The most commonly used drugs
      are opioids, clonidine, and ketamine. However, their use has been limited by adverse effects
      in children.

      Recently, the importance of magnesium in analgesic effects has been increased. Magnesium is
      the fourth most abundant cation in the body. It has antinociceptive effects in human and
      these effects are primarily based on the regulation of calcium influx into the cell.
      Magnesium is a physiological calcium antagonist and blocks N-methyl-D-aspartate (NMDA)
      receptor and such NMDA antagonism prevents the central sensitization from nociceptive
      stimulation. Many study suggested that epidurally administered magnesium could reduce the
      postoperative pain in adults. But few studies are available about the use of magnesium in
      pediatrics.

      The investigators performed prospective randomized double-blind study to examine the
      analgesic effect of magnesium added to ropivacaine and ropivacaine alone in caudal analgesia
      on postoperative pain control in pediatric patients undergoing inguinal hernia repair.

      80 children (aged 2- 6 yr) undergoing inguinal hernia repair were included in this
      prospective, randomized, double-blinded study. After inhalation induction of general
      anesthesia, caudal block was applied. Patients were randomly assigned in two groups. Normal
      saline 0.5mL added to ropivacaine 0.15% 1.0 ml/kg was administered to Group R , Magnesium
      50mg (Magnesium 10% 0.5mL)added to ropivacaine 0.15% 1.0ml/kg to Group MR. Postoperative pain
      was recorded at 30min and 1,2,3 h by using Hospital of Eastern Ontario Pain Scale (CHEOPS,
      0-10) and Faces Legs Activity Cry Consolability tool (FLACC, 0-10). Participants will be
      followed for the duration of hospital stay, an expected average of 3 hours.

      After discharge, rescue analgesic consumption, pain scores (Parents Postoperative Pain
      Measurement, PPPM), and adverse effects were evaluated for 48h.

      The time to first supplemental oral analgesic medication demand was defined as the time from
      the end of surgery to the first registration of a PPPM( 0 - 15) ≥ 6 by parent's observation.
      48 hours after surgery, reports of delayed side effects and demands for rescue analgesics
      from the child were gathered from parents via a telephone interview.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: The number of children who required analgesics
time frame: at 24 and 48 hours after surgery
description: Primary outcome is defined as the number of patients who required analgesics after discharge. Postoperative pain at home is assessed by parent using the PPPM scale that consists of 15 questions requiring a "yes" or "no" answer (yes = 1 point and no = 0 point). A PPPM score ≥ 6 by parent's observation is considered to represent clinically significant pain, requiring analgesics.
The PPPM is a 15-item observational checklist measure of pain intensity that was designed to be used by parents to support research and clinical postoperative care for children at home.
arm group label: placebo group
arm group type: Placebo Comparator
description: normal saline 0.5ml
arm group label: magnesum group
arm group type: Experimental
description: After inhalation induction of general anesthesia, caudal block was applied. Patients were randomly assigned in two groups. Normal saline 0.5mL added to ropivacaine 0.15% 1.0 ml/kg was administered to Group R , Magnesium 50mg (Magnesium 10% 0.5mL)added to ropivacaine 0.15% 1.0ml/kg to Group MR.
intervention type: Drug
intervention name: caudal block
description: After inhalation induction of general anesthesia, caudal block was applied. Patients were randomly assigned in two groups. Normal saline 0.5mL added to ropivacaine 0.15% 1.0 ml/kg was administered to Group R , Magnesium 50mg (Magnesium 10% 0.5mL)added to ropivacaine 0.15% 1.0ml/kg to Group MR.
arm group label: magnesum group
intervention type: Drug
intervention name: normal saline 0.5ml
arm group label: placebo group
criteria: 
gender: All
minimum age: 2 Years
maximum age: 6 Years
healthy volunteers: No
facility: 
country: Korea, Republic of
citation: Farouk S. Pre-incisional epidural magnesium provides pre-emptive and preventive analgesia in patients undergoing abdominal hysterectomy. Br J Anaesth. 2008 Nov;101(5):694-9. doi: 10.1093/bja/aen274. Epub 2008 Sep 26.
PMID: 18820247
responsible party type: Sponsor
mesh term: Hernia
mesh term: Hernia, Inguinal