<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/NCT02250703</url>
  </required_header>
  <id_info>
    <org_study_id>2014-0131</org_study_id>
    <nct_id>NCT02250703</nct_id>
  </id_info>
  <brief_title>Intranasal Dexmedetomidine Premedication in Children</brief_title>
  <official_title>Comparing Intranasal Dexmedetomidine With Oral Midazolam as Premedication for Older Children Undergoing General Anesthesia for Dental Rehabilitation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Mississippi Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Mississippi Medical Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      BACKGROUND INFORMATION AND RATIONALE&#xD;
&#xD;
      Pediatric patients scheduled for dental procedures under general anesthesia can have&#xD;
      significant anxiety before the procedure. They are commonly pre medicated to minimize&#xD;
      distress and to facilitate a smooth induction of anesthesia. Oral Midazolam at 0.5mg/kg dose&#xD;
      is more widely used for this purpose . However the commonly used maximum dose is up to 15mg.&#xD;
      It also has many limitations such as paradoxical reaction, increased incidence of emergence&#xD;
      delirium and negative postoperative behavior changes . Intranasal dexmedetomidine has been&#xD;
      used an effective and safe alternative premedication to oral midazolam in children. At a dose&#xD;
      of 2micrograms/kg, intranasal dexmedetomidine as premedication resulted in excellent sedation&#xD;
      in children aged 5-8yrs with no adverse hemodynamic effects. It has other advantages such as&#xD;
      providing analgesia and facilitating smooth emergence from anesthesia.&#xD;
&#xD;
      The goal of this study is to find out if intranasal dexmedetomidine is a superior alternative&#xD;
      as premedication to oral midazolam in children weighing more than 20kg undergoing general&#xD;
      anesthesia for dental rehabilitation.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      After Institutional Review Board (IRB) approval and written informed consent from patients'&#xD;
      parents or legally authorized representative, 80 children older than 5yrs and weighing more&#xD;
      than 20kg, ASA physical status 1 or 2, scheduled for elective dental rehabilitation with&#xD;
      general anesthesia will be enrolled in this prospective randomized double blinded study.&#xD;
&#xD;
      Exclusion criteria include known allergy or hypersensitivity to midazolam or dexmedetomidine,&#xD;
      uncorrected congenital heart disease or history of cardiac arrhythmia, children at risk for&#xD;
      airway obstruction (OSA or cranio facial syndrome) and pregnant minors Patients will be&#xD;
      randomly assigned to one of two groups M (midazolam) or D (dexmedetomidine) using&#xD;
      computer-generated numbers in sealed envelopes.&#xD;
&#xD;
      All the patients will be brought to their pre-op room and premedicated at least 30 min before&#xD;
      induction of anesthesia.&#xD;
&#xD;
      In M group, patients will be given oral midazolam 0.5mg/kg upto maximum dose of 15mg (5mg/ml&#xD;
      parenteral preparation) mixed with flavored syrup.&#xD;
&#xD;
      In D group, patients will be given intranasal dexmedetomidine 2mcg/kg upto maximum dose of&#xD;
      100mcg prepared from 100mcg/ml parenteral preparation (Hospira R). The drug will be&#xD;
      administered using a intranasal mucosal administration device (LMA MAD NasalTM). Atomized&#xD;
      nasal medications offer rapid absorption across mucosal membranes to the blood stream&#xD;
      avoiding first-pass metabolism.&#xD;
&#xD;
      Parents will be present in the room during premedication. The Anesthesia personnel involved&#xD;
      in the care of the patient (MD or CRNA) will prepare and administer all study drugs. All&#xD;
      patients will be continuously monitored in the holding area with pulse oximetry and blood&#xD;
      pressure monitor. HR, SPO2 and BP will be recorded every 15min after administration of&#xD;
      premedication until transfer to the OR. Emergency medications including atropine and&#xD;
      epinephrine will be immediately available in the pre-op holding area. Oral midazolam has been&#xD;
      used with very little effect on hemodynamic parameters. Although intranasal dexmedetomidine&#xD;
      can decrease HR and BP, it has been used at the dose of 2mcg/kg without any adverse&#xD;
      hemodynamic effect . Any intervention needed to treat drop in HR (&lt;50) and BP (sys BP &lt;60)&#xD;
      after the drug administration will be recorded.&#xD;
&#xD;
      Behavior of the children at the time of premedication will be documented ( easy or&#xD;
      difficult). Any unwanted effects during administration such as spitting or vomiting of oral&#xD;
      drug and pain or irritation from nasal administration will be documented.&#xD;
&#xD;
      The dental resident blinded to study drug administration will do the pre-operative sedation&#xD;
      status and acceptance of mask induction.&#xD;
&#xD;
      Sedation status will be assessed using University of Michigan sedation scale (UMSS)on&#xD;
      separation from parents and at induction after moving to the OR table. Acceptance of mask&#xD;
      induction will be documented on a 4-point scale.&#xD;
&#xD;
      Standard ASA monitors will be applied before induction of anesthesia. All patients will&#xD;
      undergo mask induction with O2/N2O/Sevo. An intravenous line will be inserted and secured.&#xD;
      Both nostrils will be prepped nasal drops and tips of tracheal tubes covered with red rubber&#xD;
      to minimize bleeding. Nasal intubation will be performed with direct laryngoscopy and&#xD;
      McGill's forceps. Appropriate size cuffed tracheal tubes will be inserted and secured after&#xD;
      additional IV medications with propofol 2-3mg/kg and fentanyl 1-2mcg/kg. Anesthesia will be&#xD;
      maintained with O2/Sevo, IV morphine 0.05 to 0.1mg/kg and IV toradol 0.5mg/kg (if there is no&#xD;
      allergy or contraindication to morphine or toradol) After the completion of procedure,&#xD;
      patients will be extubated in the operating room and brought to recovery room and allowed to&#xD;
      wake up slowly in the recovery position.&#xD;
&#xD;
      PACU nurses will evaluate Behavior at awakening using four-point wake up score (9,20).&#xD;
      Patients will also be asked if they remember mask induction (yes or no) when they are ready&#xD;
      for discharge. Incidence of nausea, vomiting, shivering will be documented in PACU. Time&#xD;
      spent in phase 1 recovery room will also be recorded .&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2014</start_date>
  <completion_date type="Actual">September 2016</completion_date>
  <primary_completion_date type="Actual">September 2016</primary_completion_date>
  <phase>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>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>University of Michigan Sedation Scale</measure>
    <time_frame>Day 0:Just before the patient will be brought to the operating room</time_frame>
    <description>Level of sedation at separation from parents and at the time of mask induction will be measured on a scale of 0 to 4 (University of Michigan Sedation Scale)&#xD;
University of Michigan Sedation Scale:&#xD;
0 -Awake/Alert&#xD;
1 -Minimally Sedated: Tired/sleepy, appropriate response to verbal conversation and/or sounds.&#xD;
2- Moderately Sedated: Somnolent/sleeping, easily aroused with light tactile stimulation.&#xD;
3 - Deeply Sedated: Deep sleep, arousable only with significant physical stimulation.&#xD;
4 - Unarousable&#xD;
Moderately and Deeply sedated: Satisfactory Awake, minimally sedate, unarousable: Unsatisfactory</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Acceptance of Mask Induction</measure>
    <time_frame>Day 0: At the time when anesthesia is induced</time_frame>
    <description>on a scale of 1 to 4&#xD;
excellent( cooperative)&#xD;
good( slight fear, easily calmed)&#xD;
fair ( moderate fear, not calmed with reassurance)&#xD;
Poor( agitated, terrified) 1 and 2 are considered satisfactory 3 and 4 are considered unsatisfactory</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Wake up Behavior</measure>
    <time_frame>Day 0: At the end of surgery when the patient recovers from anesthesia</time_frame>
    <description>assessed in post anesthesia recovery unit after the procedure on a scale of 1o 4&#xD;
calm&#xD;
not calm but easily calmed&#xD;
moderately agitated or restless&#xD;
combative/disoriented 1 and 2 are considered satisfactory 3 and 4 are considered unsatisfactory</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Presence of Amnesia to Mask Induction</measure>
    <time_frame>Day 0: at the time of discharge of the patient from the recovery room</time_frame>
    <description>Yes or No (if the patient remembers mask induction)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">75</enrollment>
  <condition>Preoperative Sedation</condition>
  <arm_group>
    <arm_group_label>Midazolam</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>In M group, patients will be given oral midazolam 0.5mg/kg upto maximum dose of 15mg (5mg/ml parenteral preparation) mixed with flavored syrup as premedication</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Dexmedetomidine</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>In D group, patients will be given intranasal dexmedetomidine 2mcg/kg upto maximum dose of 100mcg prepared from 100mcg/ml parenteral preparation (Hospira R) . The drug will be administered using a intranasal mucosal administration device (LMA MAD NasalTM).</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Midazolam</intervention_name>
    <description>oral midazolam 0.5mg/kg upto maximum dose of 15mg</description>
    <arm_group_label>Midazolam</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Dexmedetomidine</intervention_name>
    <description>intranasal dexmedetomidine 2mcg/kg upto maximum dose of 100mcg</description>
    <arm_group_label>Dexmedetomidine</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Children older than 5yrs and weighing more than 20kg , who are scheduled for&#xD;
             ambulatory dental rehabilitation at Batson operating rooms.&#xD;
&#xD;
          -  ASA classification 1 or 2&#xD;
&#xD;
        Exclusion Criteria&#xD;
&#xD;
          -  Known allergy to midazolam, dexmedetomidine,morphine, fentanyl, sevoflurane and&#xD;
             propofol.&#xD;
&#xD;
          -  uncorrected congenital heart disease or history of cardiac arrhythmia,&#xD;
&#xD;
          -  children at risk for airway obstruction (OSA or cranio facial syndrome),&#xD;
&#xD;
          -  pregnant minors&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>5 Years</minimum_age>
    <maximum_age>18 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Madhankumar Sathyamoorthy, MBBS, MS</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Mississippi Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Children's of Mississippi/University of Mississipi Medical Center</name>
      <address>
        <city>Jackson</city>
        <state>Mississippi</state>
        <zip>39216</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Kain ZN, Mayes LC, Bell C, Weisman S, Hofstadter MB, Rimar S. Premedication in the United States: a status report. Anesth Analg. 1997 Feb;84(2):427-32. doi: 10.1097/00000539-199702000-00035.</citation>
    <PMID>9024042</PMID>
  </reference>
  <reference>
    <citation>Lonnqvist PA, Habre W. Midazolam as premedication: is the emperor naked or just half-dressed? Paediatr Anaesth. 2005 Apr;15(4):263-5. doi: 10.1111/j.1460-9592.2005.01600.x. No abstract available.</citation>
    <PMID>15787915</PMID>
  </reference>
  <reference>
    <citation>Kanegaye JT, Favela JL, Acosta M, Bank DE. High-dose rectal midazolam for pediatric procedures: a randomized trial of sedative efficacy and agitation. Pediatr Emerg Care. 2003 Oct;19(5):329-36. doi: 10.1097/01.pec.0000092578.40174.85.</citation>
    <PMID>14578832</PMID>
  </reference>
  <reference>
    <citation>McGraw T, Kendrick A. Oral midazolam premedication and postoperative behaviour in children. Paediatr Anaesth. 1998;8(2):117-21. doi: 10.1046/j.1460-9592.1998.00724.x.</citation>
    <PMID>9549736</PMID>
  </reference>
  <results_reference>
    <citation>Kain ZN, Caldwell-Andrews AA, Krivutza DM, Weinberg ME, Wang SM, Gaal D. Trends in the practice of parental presence during induction of anesthesia and the use of preoperative sedative premedication in the United States, 1995-2002: results of a follow-up national survey. Anesth Analg. 2004 May;98(5):1252-9, table of contents. doi: 10.1213/01.ane.0000111183.38618.d8.</citation>
    <PMID>15105196</PMID>
  </results_reference>
  <results_reference>
    <citation>Yuen VM, Hui TW, Irwin MG, Yuen MK. A comparison of intranasal dexmedetomidine and oral midazolam for premedication in pediatric anesthesia: a double-blinded randomized controlled trial. Anesth Analg. 2008 Jun;106(6):1715-21. doi: 10.1213/ane.0b013e31816c8929.</citation>
    <PMID>18499600</PMID>
  </results_reference>
  <results_reference>
    <citation>Akin A, Bayram A, Esmaoglu A, Tosun Z, Aksu R, Altuntas R, Boyaci A. Dexmedetomidine vs midazolam for premedication of pediatric patients undergoing anesthesia. Paediatr Anaesth. 2012 Sep;22(9):871-6. doi: 10.1111/j.1460-9592.2012.03802.x. Epub 2012 Jan 23.</citation>
    <PMID>22268591</PMID>
  </results_reference>
  <results_reference>
    <citation>Sheta SA, Al-Sarheed MA, Abdelhalim AA. Intranasal dexmedetomidine vs midazolam for premedication in children undergoing complete dental rehabilitation: a double-blinded randomized controlled trial. Paediatr Anaesth. 2014 Feb;24(2):181-9. doi: 10.1111/pan.12287. Epub 2013 Nov 15.</citation>
    <PMID>24237879</PMID>
  </results_reference>
  <results_reference>
    <citation>Yuen VM, Hui TW, Irwin MG, Yao TJ, Chan L, Wong GL, Shahnaz Hasan M, Shariffuddin II. A randomised comparison of two intranasal dexmedetomidine doses for premedication in children. Anaesthesia. 2012 Nov;67(11):1210-6. doi: 10.1111/j.1365-2044.2012.07309.x. Epub 2012 Sep 5.</citation>
    <PMID>22950484</PMID>
  </results_reference>
  <verification_date>June 2017</verification_date>
  <study_first_submitted>September 5, 2014</study_first_submitted>
  <study_first_submitted_qc>September 25, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 26, 2014</study_first_posted>
  <results_first_submitted>January 9, 2017</results_first_submitted>
  <results_first_submitted_qc>June 29, 2017</results_first_submitted_qc>
  <results_first_posted type="Actual">July 7, 2017</results_first_posted>
  <last_update_submitted>June 29, 2017</last_update_submitted>
  <last_update_submitted_qc>June 29, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">July 7, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Mississippi Medical Center</investigator_affiliation>
    <investigator_full_name>Madhankumar Sathyamoorthy</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <keyword>Premedication</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Midazolam</mesh_term>
    <mesh_term>Dexmedetomidine</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>No plan to share IPD</ipd_description>
  </patient_data>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Midazolam</title>
          <description>In M group, patients will be given oral midazolam 0.5mg/kg upto maximum dose of 15mg (5mg/ml parenteral preparation) mixed with flavored syrup as premedication&#xD;
Midazolam: oral midazolam 0.5mg/kg upto maximum dose of 15mg</description>
        </group>
        <group group_id="P2">
          <title>Dexmedetomidine</title>
          <description>In D group, patients will be given intranasal dexmedetomidine 2mcg/kg upto maximum dose of 100mcg prepared from 100mcg/ml parenteral preparation (Hospira R) . The drug will be administered using a intranasal mucosal administration device (LMA MAD NasalTM).&#xD;
Dexmedetomidine: intranasal dexmedetomidine 2mcg/kg upto maximum dose of 100mcg</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="38"/>
                <participants group_id="P2" count="37"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="37"/>
                <participants group_id="P2" count="36"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Midazolam</title>
          <description>In M group, patients will be given oral midazolam 0.5mg/kg upto maximum dose of 15mg (5mg/ml parenteral preparation) mixed with flavored syrup as premedication&#xD;
Midazolam: oral midazolam 0.5mg/kg upto maximum dose of 15mg</description>
        </group>
        <group group_id="B2">
          <title>Dexmedetomidine</title>
          <description>In D group, patients will be given intranasal dexmedetomidine 2mcg/kg upto maximum dose of 100mcg prepared from 100mcg/ml parenteral preparation (Hospira R) . The drug will be administered using a intranasal mucosal administration device (LMA MAD NasalTM).&#xD;
Dexmedetomidine: intranasal dexmedetomidine 2mcg/kg upto maximum dose of 100mcg</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="37"/>
            <count group_id="B2" value="36"/>
            <count group_id="B3" value="73"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="37"/>
                    <measurement group_id="B2" value="36"/>
                    <measurement group_id="B3" value="73"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="7.62" spread="2.3"/>
                    <measurement group_id="B2" value="8.0" spread="3.37"/>
                    <measurement group_id="B3" value="7.9" spread="3.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="11"/>
                    <measurement group_id="B2" value="12"/>
                    <measurement group_id="B3" value="23"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="26"/>
                    <measurement group_id="B2" value="24"/>
                    <measurement group_id="B3" value="50"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="37"/>
                    <measurement group_id="B2" value="36"/>
                    <measurement group_id="B3" value="73"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>University of Michigan Sedation Scale</title>
        <description>Level of sedation at separation from parents and at the time of mask induction will be measured on a scale of 0 to 4 (University of Michigan Sedation Scale)&#xD;
University of Michigan Sedation Scale:&#xD;
0 -Awake/Alert&#xD;
1 -Minimally Sedated: Tired/sleepy, appropriate response to verbal conversation and/or sounds.&#xD;
2- Moderately Sedated: Somnolent/sleeping, easily aroused with light tactile stimulation.&#xD;
3 - Deeply Sedated: Deep sleep, arousable only with significant physical stimulation.&#xD;
4 - Unarousable&#xD;
Moderately and Deeply sedated: Satisfactory Awake, minimally sedate, unarousable: Unsatisfactory</description>
        <time_frame>Day 0:Just before the patient will be brought to the operating room</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Midazolam</title>
            <description>In M group, patients will be given oral midazolam 0.5mg/kg upto maximum dose of 15mg (5mg/ml parenteral preparation) mixed with flavored syrup as premedication&#xD;
Midazolam: oral midazolam 0.5mg/kg upto maximum dose of 15mg</description>
          </group>
          <group group_id="O2">
            <title>Dexmedetomidine</title>
            <description>In D group, patients will be given intranasal dexmedetomidine 2mcg/kg upto maximum dose of 100mcg prepared from 100mcg/ml parenteral preparation (Hospira R) . The drug will be administered using a intranasal mucosal administration device (LMA MAD NasalTM).&#xD;
Dexmedetomidine: intranasal dexmedetomidine 2mcg/kg upto maximum dose of 100mcg</description>
          </group>
        </group_list>
        <measure>
          <title>University of Michigan Sedation Scale</title>
          <description>Level of sedation at separation from parents and at the time of mask induction will be measured on a scale of 0 to 4 (University of Michigan Sedation Scale)&#xD;
University of Michigan Sedation Scale:&#xD;
0 -Awake/Alert&#xD;
1 -Minimally Sedated: Tired/sleepy, appropriate response to verbal conversation and/or sounds.&#xD;
2- Moderately Sedated: Somnolent/sleeping, easily aroused with light tactile stimulation.&#xD;
3 - Deeply Sedated: Deep sleep, arousable only with significant physical stimulation.&#xD;
4 - Unarousable&#xD;
Moderately and Deeply sedated: Satisfactory Awake, minimally sedate, unarousable: Unsatisfactory</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="37"/>
                <count group_id="O2" value="36"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Satisfactory sedation on separation from parents</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15"/>
                    <measurement group_id="O2" value="25"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Unsatisfactory sedation on separation from parents</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="22"/>
                    <measurement group_id="O2" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Satisfactory sedation on transfer to OR table</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12"/>
                    <measurement group_id="O2" value="22"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Unsatisfactory sedation on transfer to OR table</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="25"/>
                    <measurement group_id="O2" value="14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>A sample size of at least 33 patients in each group would detect at least 30% difference in proportion of children who achieve satisfactory sedation between the M and D groups at 0.05 level of significance and 80% power</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.025</p_value>
            <p_value_desc>Difference in proportions in satisfactory sedation on separation from parents and on induction between M and D groups (Primary Outcome variables)</p_value_desc>
            <method>Chi-squared</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Acceptance of Mask Induction</title>
        <description>on a scale of 1 to 4&#xD;
excellent( cooperative)&#xD;
good( slight fear, easily calmed)&#xD;
fair ( moderate fear, not calmed with reassurance)&#xD;
Poor( agitated, terrified) 1 and 2 are considered satisfactory 3 and 4 are considered unsatisfactory</description>
        <time_frame>Day 0: At the time when anesthesia is induced</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Midazolam</title>
            <description>In M group, patients will be given oral midazolam 0.5mg/kg upto maximum dose of 15mg (5mg/ml parenteral preparation) mixed with flavored syrup as premedication&#xD;
Midazolam: oral midazolam 0.5mg/kg upto maximum dose of 15mg</description>
          </group>
          <group group_id="O2">
            <title>Dexmedetomidine</title>
            <description>In D group, patients will be given intranasal dexmedetomidine 2mcg/kg upto maximum dose of 100mcg prepared from 100mcg/ml parenteral preparation (Hospira R) . The drug will be administered using a intranasal mucosal administration device (LMA MAD NasalTM).&#xD;
Dexmedetomidine: intranasal dexmedetomidine 2mcg/kg upto maximum dose of 100mcg</description>
          </group>
        </group_list>
        <measure>
          <title>Acceptance of Mask Induction</title>
          <description>on a scale of 1 to 4&#xD;
excellent( cooperative)&#xD;
good( slight fear, easily calmed)&#xD;
fair ( moderate fear, not calmed with reassurance)&#xD;
Poor( agitated, terrified) 1 and 2 are considered satisfactory 3 and 4 are considered unsatisfactory</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="37"/>
                <count group_id="O2" value="36"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Satisfactory mask induction</title>
                  <measurement_list>
                    <measurement group_id="O1" value="35"/>
                    <measurement group_id="O2" value="29"/>
                  </measurement_list>
                </category>
                <category>
                  <title>unsatisfactory mask induction</title>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&gt;0.05</p_value>
            <method>Chi-squared</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Wake up Behavior</title>
        <description>assessed in post anesthesia recovery unit after the procedure on a scale of 1o 4&#xD;
calm&#xD;
not calm but easily calmed&#xD;
moderately agitated or restless&#xD;
combative/disoriented 1 and 2 are considered satisfactory 3 and 4 are considered unsatisfactory</description>
        <time_frame>Day 0: At the end of surgery when the patient recovers from anesthesia</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Midazolam</title>
            <description>In M group, patients will be given oral midazolam 0.5mg/kg upto maximum dose of 15mg (5mg/ml parenteral preparation) mixed with flavored syrup as premedication&#xD;
Midazolam: oral midazolam 0.5mg/kg upto maximum dose of 15mg</description>
          </group>
          <group group_id="O2">
            <title>Dexmedetomidine</title>
            <description>In D group, patients will be given intranasal dexmedetomidine 2mcg/kg upto maximum dose of 100mcg prepared from 100mcg/ml parenteral preparation (Hospira R) . The drug will be administered using a intranasal mucosal administration device (LMA MAD NasalTM).&#xD;
Dexmedetomidine: intranasal dexmedetomidine 2mcg/kg upto maximum dose of 100mcg</description>
          </group>
        </group_list>
        <measure>
          <title>Wake up Behavior</title>
          <description>assessed in post anesthesia recovery unit after the procedure on a scale of 1o 4&#xD;
calm&#xD;
not calm but easily calmed&#xD;
moderately agitated or restless&#xD;
combative/disoriented 1 and 2 are considered satisfactory 3 and 4 are considered unsatisfactory</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="37"/>
                <count group_id="O2" value="36"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>satisfactory wake up behavior</title>
                  <measurement_list>
                    <measurement group_id="O1" value="37"/>
                    <measurement group_id="O2" value="35"/>
                  </measurement_list>
                </category>
                <category>
                  <title>unsatisfactory wake up behavior</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&gt;0.05</p_value>
            <method>Chi-squared</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Presence of Amnesia to Mask Induction</title>
        <description>Yes or No (if the patient remembers mask induction)</description>
        <time_frame>Day 0: at the time of discharge of the patient from the recovery room</time_frame>
        <population>7 patients in the M group and 5 patients in D group had significant developmental delay and could not answer the question regarding memory of mask induction. Thus, only 61 were analyzed for this part</population>
        <group_list>
          <group group_id="O1">
            <title>Midazolam</title>
            <description>In M group, patients will be given oral midazolam 0.5mg/kg upto maximum dose of 15mg (5mg/ml parenteral preparation) mixed with flavored syrup as premedication&#xD;
Midazolam: oral midazolam 0.5mg/kg upto maximum dose of 15mg</description>
          </group>
          <group group_id="O2">
            <title>Dexmedetomidine</title>
            <description>In D group, patients will be given intranasal dexmedetomidine 2mcg/kg upto maximum dose of 100mcg prepared from 100mcg/ml parenteral preparation (Hospira R) . The drug will be administered using a intranasal mucosal administration device (LMA MAD NasalTM).&#xD;
Dexmedetomidine: intranasal dexmedetomidine 2mcg/kg upto maximum dose of 100mcg</description>
          </group>
        </group_list>
        <measure>
          <title>Presence of Amnesia to Mask Induction</title>
          <description>Yes or No (if the patient remembers mask induction)</description>
          <population>7 patients in the M group and 5 patients in D group had significant developmental delay and could not answer the question regarding memory of mask induction. Thus, only 61 were analyzed for this part</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="30"/>
                <count group_id="O2" value="31"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>memory of mask induction-yes</title>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                    <measurement group_id="O2" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>memory of mask induction-no</title>
                  <measurement_list>
                    <measurement group_id="O1" value="24"/>
                    <measurement group_id="O2" value="26"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&gt;0.05</p_value>
            <method>Chi-squared</method>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>After premedication, patients will be continuously monitored including HR, BP, RR and SPO2 and documented every 15 min</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Midazolam</title>
          <description>In M group, patients will be given oral midazolam 0.5mg/kg upto maximum dose of 15mg (5mg/ml parenteral preparation) mixed with flavored syrup as premedication&#xD;
Midazolam: oral midazolam 0.5mg/kg upto maximum dose of 15mg</description>
        </group>
        <group group_id="E2">
          <title>Dexmedetomidine</title>
          <description>In D group, patients will be given intranasal dexmedetomidine 2mcg/kg upto maximum dose of 100mcg prepared from 100mcg/ml parenteral preparation (Hospira R) . The drug will be administered using a intranasal mucosal administration device (LMA MAD NasalTM).&#xD;
Dexmedetomidine: intranasal dexmedetomidine 2mcg/kg upto maximum dose of 100mcg</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="36"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="36"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <limitations_and_caveats>All the consecutive patients were screened for eligibility. Patients were not selected on the basis of need for premedication.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Madhankumar Sathyamoorthy. PI</name_or_title>
      <organization>University of Mississippi Medical Center</organization>
      <phone>6018157066</phone>
      <email>msathyamoorthy@umc.edu</email>
    </point_of_contact>
  </clinical_results>
</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/NCT02250703
org study id: 2014-0131
nct id: NCT02250703
lead sponsor: 
has dmc: No
BACKGROUND INFORMATION AND RATIONALE

      Pediatric patients scheduled for dental procedures under general anesthesia can have
      significant anxiety before the procedure. They are commonly pre medicated to minimize
      distress and to facilitate a smooth induction of anesthesia. Oral Midazolam at 0.5mg/kg dose
      is more widely used for this purpose . However the commonly used maximum dose is up to 15mg.
      It also has many limitations such as paradoxical reaction, increased incidence of emergence
      delirium and negative postoperative behavior changes . Intranasal dexmedetomidine has been
      used an effective and safe alternative premedication to oral midazolam in children. At a dose
      of 2micrograms/kg, intranasal dexmedetomidine as premedication resulted in excellent sedation
      in children aged 5-8yrs with no adverse hemodynamic effects. It has other advantages such as
      providing analgesia and facilitating smooth emergence from anesthesia.

      The goal of this study is to find out if intranasal dexmedetomidine is a superior alternative
      as premedication to oral midazolam in children weighing more than 20kg undergoing general
      anesthesia for dental rehabilitation.
After Institutional Review Board (IRB) approval and written informed consent from patients'
      parents or legally authorized representative, 80 children older than 5yrs and weighing more
      than 20kg, ASA physical status 1 or 2, scheduled for elective dental rehabilitation with
      general anesthesia will be enrolled in this prospective randomized double blinded study.

      Exclusion criteria include known allergy or hypersensitivity to midazolam or dexmedetomidine,
      uncorrected congenital heart disease or history of cardiac arrhythmia, children at risk for
      airway obstruction (OSA or cranio facial syndrome) and pregnant minors Patients will be
      randomly assigned to one of two groups M (midazolam) or D (dexmedetomidine) using
      computer-generated numbers in sealed envelopes.

      All the patients will be brought to their pre-op room and premedicated at least 30 min before
      induction of anesthesia.

      In M group, patients will be given oral midazolam 0.5mg/kg upto maximum dose of 15mg (5mg/ml
      parenteral preparation) mixed with flavored syrup.

      In D group, patients will be given intranasal dexmedetomidine 2mcg/kg upto maximum dose of
      100mcg prepared from 100mcg/ml parenteral preparation (Hospira R). The drug will be
      administered using a intranasal mucosal administration device (LMA MAD NasalTM). Atomized
      nasal medications offer rapid absorption across mucosal membranes to the blood stream
      avoiding first-pass metabolism.

      Parents will be present in the room during premedication. The Anesthesia personnel involved
      in the care of the patient (MD or CRNA) will prepare and administer all study drugs. All
      patients will be continuously monitored in the holding area with pulse oximetry and blood
      pressure monitor. HR, SPO2 and BP will be recorded every 15min after administration of
      premedication until transfer to the OR. Emergency medications including atropine and
      epinephrine will be immediately available in the pre-op holding area. Oral midazolam has been
      used with very little effect on hemodynamic parameters. Although intranasal dexmedetomidine
      can decrease HR and BP, it has been used at the dose of 2mcg/kg without any adverse
      hemodynamic effect . Any intervention needed to treat drop in HR (<50) and BP (sys BP <60)
      after the drug administration will be recorded.

      Behavior of the children at the time of premedication will be documented ( easy or
      difficult). Any unwanted effects during administration such as spitting or vomiting of oral
      drug and pain or irritation from nasal administration will be documented.

      The dental resident blinded to study drug administration will do the pre-operative sedation
      status and acceptance of mask induction.

      Sedation status will be assessed using University of Michigan sedation scale (UMSS)on
      separation from parents and at induction after moving to the OR table. Acceptance of mask
      induction will be documented on a 4-point scale.

      Standard ASA monitors will be applied before induction of anesthesia. All patients will
      undergo mask induction with O2/N2O/Sevo. An intravenous line will be inserted and secured.
      Both nostrils will be prepped nasal drops and tips of tracheal tubes covered with red rubber
      to minimize bleeding. Nasal intubation will be performed with direct laryngoscopy and
      McGill's forceps. Appropriate size cuffed tracheal tubes will be inserted and secured after
      additional IV medications with propofol 2-3mg/kg and fentanyl 1-2mcg/kg. Anesthesia will be
      maintained with O2/Sevo, IV morphine 0.05 to 0.1mg/kg and IV toradol 0.5mg/kg (if there is no
      allergy or contraindication to morphine or toradol) After the completion of procedure,
      patients will be extubated in the operating room and brought to recovery room and allowed to
      wake up slowly in the recovery position.

      PACU nurses will evaluate Behavior at awakening using four-point wake up score (9,20).
      Patients will also be asked if they remember mask induction (yes or no) when they are ready
      for discharge. Incidence of nausea, vomiting, shivering will be documented in PACU. Time
      spent in phase 1 recovery room will also be recorded .
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: Single (Outcomes Assessor)
measure: University of Michigan Sedation Scale
time frame: Day 0:Just before the patient will be brought to the operating room
description: Level of sedation at separation from parents and at the time of mask induction will be measured on a scale of 0 to 4 (University of Michigan Sedation Scale)
University of Michigan Sedation Scale:
0 -Awake/Alert
1 -Minimally Sedated: Tired/sleepy, appropriate response to verbal conversation and/or sounds.
2- Moderately Sedated: Somnolent/sleeping, easily aroused with light tactile stimulation.
3 - Deeply Sedated: Deep sleep, arousable only with significant physical stimulation.
4 - Unarousable
Moderately and Deeply sedated: Satisfactory Awake, minimally sedate, unarousable: Unsatisfactory
measure: Acceptance of Mask Induction
time frame: Day 0: At the time when anesthesia is induced
description: on a scale of 1 to 4
excellent( cooperative)
good( slight fear, easily calmed)
fair ( moderate fear, not calmed with reassurance)
Poor( agitated, terrified) 1 and 2 are considered satisfactory 3 and 4 are considered unsatisfactory
measure: Wake up Behavior
time frame: Day 0: At the end of surgery when the patient recovers from anesthesia
description: assessed in post anesthesia recovery unit after the procedure on a scale of 1o 4
calm
not calm but easily calmed
moderately agitated or restless
combative/disoriented 1 and 2 are considered satisfactory 3 and 4 are considered unsatisfactory
measure: Presence of Amnesia to Mask Induction
time frame: Day 0: at the time of discharge of the patient from the recovery room
description: Yes or No (if the patient remembers mask induction)
arm group label: Midazolam
arm group type: Active Comparator
description: In M group, patients will be given oral midazolam 0.5mg/kg upto maximum dose of 15mg (5mg/ml parenteral preparation) mixed with flavored syrup as premedication
arm group label: Dexmedetomidine
arm group type: Experimental
description: In D group, patients will be given intranasal dexmedetomidine 2mcg/kg upto maximum dose of 100mcg prepared from 100mcg/ml parenteral preparation (Hospira R) . The drug will be administered using a intranasal mucosal administration device (LMA MAD NasalTM).
intervention type: Drug
intervention name: Midazolam
description: oral midazolam 0.5mg/kg upto maximum dose of 15mg
arm group label: Midazolam
intervention type: Drug
intervention name: Dexmedetomidine
description: intranasal dexmedetomidine 2mcg/kg upto maximum dose of 100mcg
arm group label: Dexmedetomidine
criteria: 
gender: All
minimum age: 5 Years
maximum age: 18 Years
healthy volunteers: No
last name: Madhankumar Sathyamoorthy, MBBS, MS
role: Principal Investigator
affiliation: University of Mississippi Medical Center
facility: 
country: United States
citation: Kain ZN, Mayes LC, Bell C, Weisman S, Hofstadter MB, Rimar S. Premedication in the United States: a status report. Anesth Analg. 1997 Feb;84(2):427-32. doi: 10.1097/00000539-199702000-00035.
PMID: 9024042
citation: Lonnqvist PA, Habre W. Midazolam as premedication: is the emperor naked or just half-dressed? Paediatr Anaesth. 2005 Apr;15(4):263-5. doi: 10.1111/j.1460-9592.2005.01600.x. No abstract available.
PMID: 15787915
citation: Kanegaye JT, Favela JL, Acosta M, Bank DE. High-dose rectal midazolam for pediatric procedures: a randomized trial of sedative efficacy and agitation. Pediatr Emerg Care. 2003 Oct;19(5):329-36. doi: 10.1097/01.pec.0000092578.40174.85.
PMID: 14578832
citation: McGraw T, Kendrick A. Oral midazolam premedication and postoperative behaviour in children. Paediatr Anaesth. 1998;8(2):117-21. doi: 10.1046/j.1460-9592.1998.00724.x.
PMID: 9549736
citation: Kain ZN, Caldwell-Andrews AA, Krivutza DM, Weinberg ME, Wang SM, Gaal D. Trends in the practice of parental presence during induction of anesthesia and the use of preoperative sedative premedication in the United States, 1995-2002: results of a follow-up national survey. Anesth Analg. 2004 May;98(5):1252-9, table of contents. doi: 10.1213/01.ane.0000111183.38618.d8.
PMID: 15105196
citation: Yuen VM, Hui TW, Irwin MG, Yuen MK. A comparison of intranasal dexmedetomidine and oral midazolam for premedication in pediatric anesthesia: a double-blinded randomized controlled trial. Anesth Analg. 2008 Jun;106(6):1715-21. doi: 10.1213/ane.0b013e31816c8929.
PMID: 18499600
citation: Akin A, Bayram A, Esmaoglu A, Tosun Z, Aksu R, Altuntas R, Boyaci A. Dexmedetomidine vs midazolam for premedication of pediatric patients undergoing anesthesia. Paediatr Anaesth. 2012 Sep;22(9):871-6. doi: 10.1111/j.1460-9592.2012.03802.x. Epub 2012 Jan 23.
PMID: 22268591
citation: Sheta SA, Al-Sarheed MA, Abdelhalim AA. Intranasal dexmedetomidine vs midazolam for premedication in children undergoing complete dental rehabilitation: a double-blinded randomized controlled trial. Paediatr Anaesth. 2014 Feb;24(2):181-9. doi: 10.1111/pan.12287. Epub 2013 Nov 15.
PMID: 24237879
citation: Yuen VM, Hui TW, Irwin MG, Yao TJ, Chan L, Wong GL, Shahnaz Hasan M, Shariffuddin II. A randomised comparison of two intranasal dexmedetomidine doses for premedication in children. Anaesthesia. 2012 Nov;67(11):1210-6. doi: 10.1111/j.1365-2044.2012.07309.x. Epub 2012 Sep 5.
PMID: 22950484
responsible party type: Principal Investigator
investigator affiliation: University of Mississippi Medical Center
investigator full name: Madhankumar Sathyamoorthy
investigator title: Assistant Professor
mesh term: Midazolam
mesh term: Dexmedetomidine
sharing ipd: No
ipd description: No plan to share IPD
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: All the consecutive patients were screened for eligibility. Patients were not selected on the basis of need for premedication.
point of contact: 