<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/NCT02985697</url>
  </required_header>
  <id_info>
    <org_study_id>8001</org_study_id>
    <nct_id>NCT02985697</nct_id>
  </id_info>
  <brief_title>Safety and Efficacy of Intranasal Dexmedetomidine</brief_title>
  <official_title>Safety and Efficacy of Intranasal Dexmedetomidine as a Sedative in Pediatric Dentistry: a Randomized, Double-blind Clinical Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Bon Secours Pediatric Dental Associates</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Bon Secours Pediatric Dental Associates</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of this study is to evaluate the efficacy and safety of intranasal dexmedetomidine&#xD;
      when used in combination with oral midazolam and/or nitrous oxide for moderate sedation&#xD;
      during pediatric outpatient dental procedures.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study will be organized as a prospective, randomized, double-blind trial in which&#xD;
      children who meet the study criteria are randomly separated into three test groups (IN DEX,&#xD;
      MIDDEX, and NOMIDDEX) and one control group (CTRL). Patients will be scheduled to complete&#xD;
      one quadrant of dental care per sedation. Dental procedures to be performed include composite&#xD;
      restorations, sealants, stainless steel crowns, pulp therapy, and extractions, with the exact&#xD;
      number and type dependant on each patient's individual treatment plan.&#xD;
&#xD;
      Group IN DEX will receive a placebo dose of flavored water followed by 3 mcg/kg intranasal&#xD;
      dexmedetomidine in conjunction with 50/50 nitrous oxide/oxygen at a calculated flow rate. If&#xD;
      adequate sedation is not obtained within 60 minutes of drug administration, the sedation will&#xD;
      be considered a failure and the procedure will be terminated and rescheduled for completion&#xD;
      of care using deep sedation or general anesthesia, in keeping with normal office policy.&#xD;
      Second doses of intranasal dexmedetomidine or placebo will not be given.&#xD;
&#xD;
      Group MIDDEX will receive 3 mcg/kg intranasal dexmedetomidine and 0.5 mg/kg oral midazolam&#xD;
      and 100% oxygen at a calculated flow rate (oxygen administration to function as placebo for&#xD;
      nitrous oxide). If adequate sedation is not obtained within 60 minutes of drug&#xD;
      administration, the sedation will be considered a failure and the procedure will be&#xD;
      terminated and rescheduled for completion of care using deep sedation or general anesthesia,&#xD;
      in keeping with normal office policy. Second doses of intranasal dexmedetomidine or oral&#xD;
      midazolam will not be given.&#xD;
&#xD;
      Group NOMIDDEX will receive 3 mcg/kg intranasal dexmedetomidine, 0.5 mg/kg oral midazolam,&#xD;
      and 50/50 nitrous oxide/oxygen at a calculated flow rate. If adequate sedation is not&#xD;
      obtained within 60 minutes of drug administration, the sedation will be considered a failure&#xD;
      and the procedure will be terminated and rescheduled for completion of care using deep&#xD;
      sedation or general anesthesia, in keeping with normal office policy. Second doses of&#xD;
      intranasal dexmedetomidine or oral midazolam will not be given.&#xD;
&#xD;
      The control group, Group CTRL, will receive a placebo dose of normal saline and 0.5 mg/kg&#xD;
      oral midazolam and 50/50 nitrous oxide/oxygen at a calculated flow rate. Midazolam was chosen&#xD;
      as the control due to its well documented history of use in pediatric procedural sedations.&#xD;
      If adequate sedation is not obtained within 60 minutes of drug administration, the sedation&#xD;
      will be considered a failure and the procedure will be terminated and rescheduled for&#xD;
      completion of care using deep sedation or general anesthesia, in keeping with normal office&#xD;
      policy. Second doses of intranasal dexmedetomidine or oral midazolam will not be given.&#xD;
&#xD;
      The initial flow rate of nitrous oxide/oxygen will be calculated by multiplying the patient's&#xD;
      respiratory rate by their estimated tidal volume. Tidal volume is estimated at 10 ml/kg. The&#xD;
      flow rate will then adjusted to the patient's pulmonary needs. At the conclusion of the&#xD;
      procedure, all patients will be given 100% oxygen for at least 5 minutes and allowed to&#xD;
      recover to stable vital signs, level of consciousness, motor function, and adequate hydration&#xD;
      and pain control before discharge.&#xD;
&#xD;
      All intranasal drugs and placebos will be administered using the MAD300 Nasal Drug Delivery&#xD;
      Device, manufactured by Wolfe Tory. Typical particle size delivered into the nare is 30-100&#xD;
      microns. The device is 1.65 inches in length, has a tip diameter of .17 inches, and an&#xD;
      internal dead space of 0.07 ml. Dexmedetomidine will be drawn from the manufacturer's vial&#xD;
      and administered non-diluted (200 mcg/ml). The medication will be administered nearly&#xD;
      immediately (less than 1 minute from withdrawal from original vial). A maximum of 1ml will be&#xD;
      administered per nare.&#xD;
&#xD;
      All nasal administration of drugs and placebos will occur approximately 30 minutes before&#xD;
      scheduled procedure start time and all orally administration of drugs and placebos will occur&#xD;
      approximately 15 minutes before scheduled procedure start time. Administration of all inhaled&#xD;
      agents and placebos will begin approximately 5 minutes prior to scheduled procedure start&#xD;
      time. This delay will allow for coincident onset of drug effects.&#xD;
&#xD;
      In accordance with Bon Secours policy and evidence based guidelines, vital signs of all&#xD;
      patients will be monitored by a Bon Secours nurse from the time of drug administration until&#xD;
      discharge. Pulse oximetry, heart rate, respiratory rate, and end tidal CO2 will be monitored&#xD;
      continuously. Blood pressure will be measured via an appropriately sized arm cuff every 5&#xD;
      minutes, beginning 5 minutes prior to first drug or placebo administration and ending when&#xD;
      the patient meets discharge criteria. The sedating dentist will be present in a supervisory&#xD;
      role for the duration of the sedation and remain immediately available until the patient is&#xD;
      discharged.&#xD;
&#xD;
      In accordance with Bon Secours policy, all patients will be required to have a history and&#xD;
      physical completed by their primary care provider a maximum of 30 days prior to date of&#xD;
      procedure. Patients are also required to observe hospital pre-operative fasting guidelines&#xD;
      (NPO solids, milk, formula &gt; 6 hours, breast milk &gt; 4 hours, clear liquids &gt; 2 hours).&#xD;
      Topical and local anesthesia (2% lidocaine with 1:100,000 epinephrine) will be administered&#xD;
      prior to operative procedures to facilitate pain control. Patient caregivers will be given&#xD;
      appropriate post-operative instructions. Each patient will be followed up with a phone call&#xD;
      the evening of the procedure and the next day to inquire about any complications and whether&#xD;
      or not the child has returned to baseline activity.&#xD;
&#xD;
      Age, weight, gender, ASA status, dosages of all drugs used, monitoring provider, procedural&#xD;
      times, adverse events, required interventions, and quality of sedation will be recorded.&#xD;
      Apnea, desaturation, airway obstruction, bradycardia, hypotension, fever, and inability to&#xD;
      complete the procedure will be considered minor adverse events. Major adverse events are&#xD;
      defined as death, aspiration, cardiac arrest, unplanned hospital admission, and level-of-care&#xD;
      increase.&#xD;
&#xD;
      If a patient has 3 consecutive blood pressure readings (taken at 5 minute intervals) that&#xD;
      fall below the 5th percentile for age, the hypotension protocol will be initiated. The&#xD;
      hypotension protocol consists of: (1) Placement of an IV. (2) Administration of 20 ml/kg of&#xD;
      IV normal saline every 5 minutes (maximum of 60 ml/kg over 15 minutes) (3) Concentration of&#xD;
      nitrous oxide will be reduced to 25%, if applicable and no additional sedative agents will be&#xD;
      administered (4) If blood pressure improves with intervention and the patient remains&#xD;
      adequately sedated, the scheduled dental procedures will be completed. (5) If intervention is&#xD;
      unsuccessful and blood pressure does not improve, the procedure will be terminated and the&#xD;
      patient will be transferred to the emergency room for level of care increase.&#xD;
&#xD;
      In the event that a patient experiences rage, agitation, or paradoxical excitation, they will&#xD;
      be restrained using protective stabilization for their safety. Consent for protective&#xD;
      stabilization will be obtained when consent for sedation and study participation is obtained.&#xD;
&#xD;
      Patient olfaction will be assessed preoperatively and postoperatively using standard&#xD;
      anesthesia olfactory oils when possible (based on pt age and developmental status). Nasal&#xD;
      mucosa will be examined preoperatively and postoperatively by the attending sedationist.&#xD;
      Abnormalities will be referred to the patient's primary care provider.&#xD;
&#xD;
      Sedation quality and patient behavior will be evaluated using the University of Michigan&#xD;
      sedation scale.&#xD;
&#xD;
      Safety will be assessed by analyzing adverse events. Efficacy will be assessed by analyzing&#xD;
      the quality of sedation based on scoring from the University of Michigan Scale.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date>January 2017</start_date>
  <completion_date type="Anticipated">June 2018</completion_date>
  <primary_completion_date type="Anticipated">January 2018</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Triple (Participant, Care Provider, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Adverse Events</measure>
    <time_frame>1 year</time_frame>
    <description>Apnea, desaturation, airway obstruction, bradycardia, hypotension, fever, and inability to complete the procedure will be considered minor adverse events. Major adverse events are defined as death, aspiration, cardiac arrest, unplanned hospital admission, and level-of-care increase. Required interventions to correct adverse events will also be recorded (such as IV fluids to improve hypotension).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Quality of Sedation</measure>
    <time_frame>1 year</time_frame>
    <description>Sedation quality and patient behavior will be evaluated using the criteria from the University of Michigan sedation scale.</description>
  </primary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Safety and Efficacy of Intranasal Dexmedetomidine</condition>
  <arm_group>
    <arm_group_label>IN DEX</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Group IN DEX will receive a placebo dose of flavored water followed by 3 mcg/kg intranasal dexmedetomidine in conjunction with 50/50 nitrous oxide/oxygen at a calculated flow rate. If adequate sedation is not obtained within 60 minutes of drug administration, the sedation will be considered a failure and the procedure will be terminated and rescheduled for completion of care using deep sedation or general anesthesia, in keeping with normal office policy. Second doses of intranasal dexmedetomidine or placebo will not be given.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>MIDDEX</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Group MIDDEX will receive 3 mcg/kg intranasal dexmedetomidine and 0.5 mg/kg oral midazolam and 100% oxygen at a calculated flow rate (oxygen administration to function as placebo for nitrous oxide). If adequate sedation is not obtained within 60 minutes of drug administration, the sedation will be considered a failure and the procedure will be terminated and rescheduled for completion of care using deep sedation or general anesthesia, in keeping with normal office policy. Second doses of intranasal dexmedetomidine or oral midazolam will not be given.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>NOMIDDEX</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Group NOMIDDEX will receive 3 mcg/kg intranasal dexmedetomidine, 0.5 mg/kg oral midazolam, and 50/50 nitrous oxide/oxygen at a calculated flow rate. If adequate sedation is not obtained within 60 minutes of drug administration, the sedation will be considered a failure and the procedure will be terminated and rescheduled for completion of care using deep sedation or general anesthesia, in keeping with normal office policy. Second doses of intranasal dexmedetomidine or oral midazolam will not be given.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>CTRL</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The control group, Group CTRL, will receive a placebo dose of normal saline and 0.5 mg/kg oral midazolam and 50/50 nitrous oxide/oxygen at a calculated flow rate. Midazolam was chosen as the control due to its well documented history of use in pediatric procedural sedations. If adequate sedation is not obtained within 60 minutes of drug administration, the sedation will be considered a failure and the procedure will be terminated and rescheduled for completion of care using deep sedation or general anesthesia, in keeping with normal office policy. Second doses of intranasal dexmedetomidine or oral midazolam will not be given.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Dexmedetomidine</intervention_name>
    <description>The intervention being tested is intranasal dexmedetomidine</description>
    <arm_group_label>IN DEX</arm_group_label>
    <arm_group_label>MIDDEX</arm_group_label>
    <arm_group_label>NOMIDDEX</arm_group_label>
    <other_name>Precedex</other_name>
    <other_name>Dexdor</other_name>
    <other_name>Dexdomitor</other_name>
    <other_name>Sileo</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Midazolam Hydrochloride</intervention_name>
    <description>Oral midazolam is being used as the Active Comparator. It will also be used in conjunction with IN dexmedetomidine in some experimental groups.</description>
    <arm_group_label>CTRL</arm_group_label>
    <arm_group_label>MIDDEX</arm_group_label>
    <arm_group_label>NOMIDDEX</arm_group_label>
    <other_name>Versed</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Nitrous Oxide</intervention_name>
    <description>Nitrous oxide to be administered in conjunction with other interventions, per study design.</description>
    <arm_group_label>CTRL</arm_group_label>
    <arm_group_label>IN DEX</arm_group_label>
    <arm_group_label>NOMIDDEX</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Patients aged from 3 through 6 years of age.&#xD;
&#xD;
          2. Patients who are appropriate for in-office sedation for dental care.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patients younger than 3 or older than 6 years of age.&#xD;
&#xD;
          2. History of failed sedation.&#xD;
&#xD;
          3. BMI greater than 30.&#xD;
&#xD;
          4. Patients weighing less than 10 kgs.&#xD;
&#xD;
          5. Patients weighing more than 25 kgs.&#xD;
&#xD;
          6. Patients who are deemed unsuitable for sedation by a physician at their preoperative&#xD;
             history and physical.&#xD;
&#xD;
          7. Patients who are deemed unsuitable for in-office sedation in accordance with Bon&#xD;
             Secours policy (American Society of Anesthesiologists [ASA] Classification greater&#xD;
             than II, Mallampati score greater than 2, Brodsky tonsil score greater than 2).&#xD;
&#xD;
          8. Patients with sleep apnea.&#xD;
&#xD;
          9. Patients with a history of an unfavorable reaction to DEX or clonidine.&#xD;
&#xD;
         10. Patients with pulmonary hypertension.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>3 Years</minimum_age>
    <maximum_age>6 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Bon Secours Pediatric Dental Associates</name>
      <address>
        <city>Richmond</city>
        <state>Virginia</state>
        <zip>23230</zip>
        <country>United States</country>
      </address>
    </facility>
    <contact>
      <last_name>John H Unkel, MD, DDS</last_name>
      <phone>804-893-8715</phone>
      <email>john_unkel@bshsi.org</email>
    </contact>
    <contact_backup>
      <last_name>Carson M Cruise, DMD</last_name>
      <phone>804-893-8715</phone>
      <email>carson_cruise@bshsi.org</email>
    </contact_backup>
    <investigator>
      <last_name>Carson M Cruise, DMD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Brittany L Ko, DDS</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>December 2016</verification_date>
  <study_first_submitted>December 5, 2016</study_first_submitted>
  <study_first_submitted_qc>December 6, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 7, 2016</study_first_posted>
  <last_update_submitted>December 6, 2016</last_update_submitted>
  <last_update_submitted_qc>December 6, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 7, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Midazolam</mesh_term>
    <mesh_term>Dexmedetomidine</mesh_term>
    <mesh_term>Nitrous Oxide</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <study_docs>
    <study_doc>
      <doc_id>DEXProtocol</doc_id>
      <doc_type>Study Protocol</doc_type>
      <doc_url>https://drive.google.com/open?id=0BwBFaEmsvS0PYnlzVDUyMGREWFk</doc_url>
      <doc_comment>Protocol for the study; includes introduction, design, and references/citations.</doc_comment>
    </study_doc>
  </study_docs>
  <!-- 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/NCT02985697
org study id: 8001
nct id: NCT02985697
lead sponsor: 
has dmc: Yes
The aim of this study is to evaluate the efficacy and safety of intranasal dexmedetomidine
      when used in combination with oral midazolam and/or nitrous oxide for moderate sedation
      during pediatric outpatient dental procedures.
The study will be organized as a prospective, randomized, double-blind trial in which
      children who meet the study criteria are randomly separated into three test groups (IN DEX,
      MIDDEX, and NOMIDDEX) and one control group (CTRL). Patients will be scheduled to complete
      one quadrant of dental care per sedation. Dental procedures to be performed include composite
      restorations, sealants, stainless steel crowns, pulp therapy, and extractions, with the exact
      number and type dependant on each patient's individual treatment plan.

      Group IN DEX will receive a placebo dose of flavored water followed by 3 mcg/kg intranasal
      dexmedetomidine in conjunction with 50/50 nitrous oxide/oxygen at a calculated flow rate. If
      adequate sedation is not obtained within 60 minutes of drug administration, the sedation will
      be considered a failure and the procedure will be terminated and rescheduled for completion
      of care using deep sedation or general anesthesia, in keeping with normal office policy.
      Second doses of intranasal dexmedetomidine or placebo will not be given.

      Group MIDDEX will receive 3 mcg/kg intranasal dexmedetomidine and 0.5 mg/kg oral midazolam
      and 100% oxygen at a calculated flow rate (oxygen administration to function as placebo for
      nitrous oxide). If adequate sedation is not obtained within 60 minutes of drug
      administration, the sedation will be considered a failure and the procedure will be
      terminated and rescheduled for completion of care using deep sedation or general anesthesia,
      in keeping with normal office policy. Second doses of intranasal dexmedetomidine or oral
      midazolam will not be given.

      Group NOMIDDEX will receive 3 mcg/kg intranasal dexmedetomidine, 0.5 mg/kg oral midazolam,
      and 50/50 nitrous oxide/oxygen at a calculated flow rate. If adequate sedation is not
      obtained within 60 minutes of drug administration, the sedation will be considered a failure
      and the procedure will be terminated and rescheduled for completion of care using deep
      sedation or general anesthesia, in keeping with normal office policy. Second doses of
      intranasal dexmedetomidine or oral midazolam will not be given.

      The control group, Group CTRL, will receive a placebo dose of normal saline and 0.5 mg/kg
      oral midazolam and 50/50 nitrous oxide/oxygen at a calculated flow rate. Midazolam was chosen
      as the control due to its well documented history of use in pediatric procedural sedations.
      If adequate sedation is not obtained within 60 minutes of drug administration, the sedation
      will be considered a failure and the procedure will be terminated and rescheduled for
      completion of care using deep sedation or general anesthesia, in keeping with normal office
      policy. Second doses of intranasal dexmedetomidine or oral midazolam will not be given.

      The initial flow rate of nitrous oxide/oxygen will be calculated by multiplying the patient's
      respiratory rate by their estimated tidal volume. Tidal volume is estimated at 10 ml/kg. The
      flow rate will then adjusted to the patient's pulmonary needs. At the conclusion of the
      procedure, all patients will be given 100% oxygen for at least 5 minutes and allowed to
      recover to stable vital signs, level of consciousness, motor function, and adequate hydration
      and pain control before discharge.

      All intranasal drugs and placebos will be administered using the MAD300 Nasal Drug Delivery
      Device, manufactured by Wolfe Tory. Typical particle size delivered into the nare is 30-100
      microns. The device is 1.65 inches in length, has a tip diameter of .17 inches, and an
      internal dead space of 0.07 ml. Dexmedetomidine will be drawn from the manufacturer's vial
      and administered non-diluted (200 mcg/ml). The medication will be administered nearly
      immediately (less than 1 minute from withdrawal from original vial). A maximum of 1ml will be
      administered per nare.

      All nasal administration of drugs and placebos will occur approximately 30 minutes before
      scheduled procedure start time and all orally administration of drugs and placebos will occur
      approximately 15 minutes before scheduled procedure start time. Administration of all inhaled
      agents and placebos will begin approximately 5 minutes prior to scheduled procedure start
      time. This delay will allow for coincident onset of drug effects.

      In accordance with Bon Secours policy and evidence based guidelines, vital signs of all
      patients will be monitored by a Bon Secours nurse from the time of drug administration until
      discharge. Pulse oximetry, heart rate, respiratory rate, and end tidal CO2 will be monitored
      continuously. Blood pressure will be measured via an appropriately sized arm cuff every 5
      minutes, beginning 5 minutes prior to first drug or placebo administration and ending when
      the patient meets discharge criteria. The sedating dentist will be present in a supervisory
      role for the duration of the sedation and remain immediately available until the patient is
      discharged.

      In accordance with Bon Secours policy, all patients will be required to have a history and
      physical completed by their primary care provider a maximum of 30 days prior to date of
      procedure. Patients are also required to observe hospital pre-operative fasting guidelines
      (NPO solids, milk, formula > 6 hours, breast milk > 4 hours, clear liquids > 2 hours).
      Topical and local anesthesia (2% lidocaine with 1:100,000 epinephrine) will be administered
      prior to operative procedures to facilitate pain control. Patient caregivers will be given
      appropriate post-operative instructions. Each patient will be followed up with a phone call
      the evening of the procedure and the next day to inquire about any complications and whether
      or not the child has returned to baseline activity.

      Age, weight, gender, ASA status, dosages of all drugs used, monitoring provider, procedural
      times, adverse events, required interventions, and quality of sedation will be recorded.
      Apnea, desaturation, airway obstruction, bradycardia, hypotension, fever, and inability to
      complete the procedure will be considered minor adverse events. Major adverse events are
      defined as death, aspiration, cardiac arrest, unplanned hospital admission, and level-of-care
      increase.

      If a patient has 3 consecutive blood pressure readings (taken at 5 minute intervals) that
      fall below the 5th percentile for age, the hypotension protocol will be initiated. The
      hypotension protocol consists of: (1) Placement of an IV. (2) Administration of 20 ml/kg of
      IV normal saline every 5 minutes (maximum of 60 ml/kg over 15 minutes) (3) Concentration of
      nitrous oxide will be reduced to 25%, if applicable and no additional sedative agents will be
      administered (4) If blood pressure improves with intervention and the patient remains
      adequately sedated, the scheduled dental procedures will be completed. (5) If intervention is
      unsuccessful and blood pressure does not improve, the procedure will be terminated and the
      patient will be transferred to the emergency room for level of care increase.

      In the event that a patient experiences rage, agitation, or paradoxical excitation, they will
      be restrained using protective stabilization for their safety. Consent for protective
      stabilization will be obtained when consent for sedation and study participation is obtained.

      Patient olfaction will be assessed preoperatively and postoperatively using standard
      anesthesia olfactory oils when possible (based on pt age and developmental status). Nasal
      mucosa will be examined preoperatively and postoperatively by the attending sedationist.
      Abnormalities will be referred to the patient's primary care provider.

      Sedation quality and patient behavior will be evaluated using the University of Michigan
      sedation scale.

      Safety will be assessed by analyzing adverse events. Efficacy will be assessed by analyzing
      the quality of sedation based on scoring from the University of Michigan Scale.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Outcomes Assessor)
measure: Adverse Events
time frame: 1 year
description: Apnea, desaturation, airway obstruction, bradycardia, hypotension, fever, and inability to complete the procedure will be considered minor adverse events. Major adverse events are defined as death, aspiration, cardiac arrest, unplanned hospital admission, and level-of-care increase. Required interventions to correct adverse events will also be recorded (such as IV fluids to improve hypotension).
measure: Quality of Sedation
time frame: 1 year
description: Sedation quality and patient behavior will be evaluated using the criteria from the University of Michigan sedation scale.
arm group label: IN DEX
arm group type: Experimental
description: Group IN DEX will receive a placebo dose of flavored water followed by 3 mcg/kg intranasal dexmedetomidine in conjunction with 50/50 nitrous oxide/oxygen at a calculated flow rate. If adequate sedation is not obtained within 60 minutes of drug administration, the sedation will be considered a failure and the procedure will be terminated and rescheduled for completion of care using deep sedation or general anesthesia, in keeping with normal office policy. Second doses of intranasal dexmedetomidine or placebo will not be given.
arm group label: MIDDEX
arm group type: Experimental
description: Group MIDDEX will receive 3 mcg/kg intranasal dexmedetomidine and 0.5 mg/kg oral midazolam and 100% oxygen at a calculated flow rate (oxygen administration to function as placebo for nitrous oxide). If adequate sedation is not obtained within 60 minutes of drug administration, the sedation will be considered a failure and the procedure will be terminated and rescheduled for completion of care using deep sedation or general anesthesia, in keeping with normal office policy. Second doses of intranasal dexmedetomidine or oral midazolam will not be given.
arm group label: NOMIDDEX
arm group type: Experimental
description: Group NOMIDDEX will receive 3 mcg/kg intranasal dexmedetomidine, 0.5 mg/kg oral midazolam, and 50/50 nitrous oxide/oxygen at a calculated flow rate. If adequate sedation is not obtained within 60 minutes of drug administration, the sedation will be considered a failure and the procedure will be terminated and rescheduled for completion of care using deep sedation or general anesthesia, in keeping with normal office policy. Second doses of intranasal dexmedetomidine or oral midazolam will not be given.
arm group label: CTRL
arm group type: Active Comparator
description: The control group, Group CTRL, will receive a placebo dose of normal saline and 0.5 mg/kg oral midazolam and 50/50 nitrous oxide/oxygen at a calculated flow rate. Midazolam was chosen as the control due to its well documented history of use in pediatric procedural sedations. If adequate sedation is not obtained within 60 minutes of drug administration, the sedation will be considered a failure and the procedure will be terminated and rescheduled for completion of care using deep sedation or general anesthesia, in keeping with normal office policy. Second doses of intranasal dexmedetomidine or oral midazolam will not be given.
intervention type: Drug
intervention name: Dexmedetomidine
description: The intervention being tested is intranasal dexmedetomidine
arm group label: IN DEX
arm group label: MIDDEX
arm group label: NOMIDDEX
other name: Precedex
other name: Dexdor
other name: Dexdomitor
other name: Sileo
intervention type: Drug
intervention name: Midazolam Hydrochloride
description: Oral midazolam is being used as the Active Comparator. It will also be used in conjunction with IN dexmedetomidine in some experimental groups.
arm group label: CTRL
arm group label: MIDDEX
arm group label: NOMIDDEX
other name: Versed
intervention type: Drug
intervention name: Nitrous Oxide
description: Nitrous oxide to be administered in conjunction with other interventions, per study design.
arm group label: CTRL
arm group label: IN DEX
arm group label: NOMIDDEX
criteria: 
gender: All
minimum age: 3 Years
maximum age: 6 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
contact: 
contact backup: 
investigator: 
investigator: 
country: United States
responsible party type: Sponsor
mesh term: Midazolam
mesh term: Dexmedetomidine
mesh term: Nitrous Oxide
sharing ipd: No
study doc: 