<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/NCT03827408</url>
  </required_header>
  <id_info>
    <org_study_id>IORG0008839</org_study_id>
    <nct_id>NCT03827408</nct_id>
  </id_info>
  <brief_title>Nebulized Midazolam, Dexmedetomidine, and Their Combination in Sedation of Preschoolers Undergoing Dental Treatment</brief_title>
  <official_title>Nebulized Midazolam, Dexmedetomidine, and Their Combination in Sedation of Preschoolers Undergoing Dental Treatment: A Randomized Clinical Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Nourhan M.Aly</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Alexandria University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Alexandria</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of the study is to evaluate the effect of nebulized Midazolam, Dexmedetomidine, and&#xD;
      their combination as procedural, moderate sedative agents in preschoolers undergoing dental&#xD;
      treatment.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Dental anxiety and fear related behaviors are global problems in Pediatric Dentistry.&#xD;
      Preschoolers represent a dental behavior management problem and there is always a debate over&#xD;
      the best behavioral management technique for preschoolers undergoing dental treatment.&#xD;
      Moderate sedation is considered as an acceptable option.&#xD;
&#xD;
      Children who need treatment under local anesthesia, for thirty minutes will be included in&#xD;
      the study. A total of 72 uncooperative pediatric dental patients, of age range 4-6 years,&#xD;
      will be selected from the Pediatric Dentistry and Dental Public Health Department, Faculty of&#xD;
      Dentistry, Alexandria University, Egypt. The participants will be randomly allocated into 3&#xD;
      groups that will undergo a procedural sedation session via a nebulizer. Children of group I&#xD;
      will receive nebulized solution of 0.5 mg/kg Midazolam, Group II will receive nebulized&#xD;
      solution of 5µg/kg Dexmedetomidine, and Group III will receive a nebulized solution of 0.3&#xD;
      mg/kg Midazolam and 3µg/kg Dexmedetomidine respectively.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 27, 2017</start_date>
  <completion_date type="Actual">December 22, 2019</completion_date>
  <primary_completion_date type="Actual">August 29, 2019</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>The participants will be randomly allocated into 3 groups that will undergo a procedural sedation session via a nebulizer. Children of group I will receive nebulized solution of 0.5 mg/kg Midazolam, Group II will receive nebulized solution of 5µg/kg Dexmedetomidine, and Group III will receive a nebulized solution of 0.3 mg/kg Midazolam and 3µg/kg Dexmedetomidine respectively.</intervention_model_description>
    <primary_purpose>Other</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
    <masking_description>The researcher, statistician and participants will be blinded to the intervention group. Only the supervisor and the anesthesiologist will be aware of the allocation group. After data collection is completed, the randomization code will be broken to reveal the allocation group.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Facemask acceptance during drug delivery</measure>
    <time_frame>during the sedation procedure</time_frame>
    <description>It will be evaluated according to Zanaty &amp; Metainy as: poor (terrified, crying and combative), fair (moderate fear of mask not calmed with reassurance), good (slight fear of mask, easily reassured) or excellent (unafraid, cooperative and accepts mask readily)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Effect of sedation on children's future behavior</measure>
    <time_frame>after one week in the follow-up session</time_frame>
    <description>Each child's behavior will be reassessed in the follow-up sessions and compared to that at baseline (before dental treatment) using Frankl scale (ranges from 0-4)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>The 'ease of treatment completion' sing separate five-point scales.</measure>
    <time_frame>immediately after completion of the dental treatment procedures.</time_frame>
    <description>This will be measured using separate five-point scales according to Surendar et al: Score 5 indicates an excellent quiet and cooperative child while score 1 indicates Prohibitive active resistance and crying; treatment cannot be rendered.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Post-operative effects of the sedation</measure>
    <time_frame>immediately after completion of the dental treatment procedures.</time_frame>
    <description>This will be assessed according to Modified Vernon et al.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Analgo-sedative effect of each drug</measure>
    <time_frame>during the sedation procedure (time taken from drug administration till reaching satisfactory sedation)</time_frame>
    <description>Onset of Sedation from drug administration until the onset of satisfactory sedation</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Analgo-sedative effect of each drug</measure>
    <time_frame>during the sedation procedure (after drug administration until reaching satisfactory sedation)</time_frame>
    <description>Sedation level using Modified Observer's Assessment of Alertness/Sedation Scale. The scale is composed of 4 categories (each has scores ranging from 1-5). The categories are responsiveness, speech, facial expression and eyes. The final score is the sum of scores: the totally awake score is 20/20 and the deeply sedated score is 9/20</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Analgo-sedative effect of each drug</measure>
    <time_frame>during local anesthesia injection to start the operative procedure</time_frame>
    <description>The analgesic effect of the sedative drugs will be assessed using &quot;Face, Legs, Activity, Cry, Consolability&quot; scale (FLACC). The scale is scored in a range of 0-10 with 0 representing no pain. The scale has five criteria, which are each assigned a score of 0, 1 or 2.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Analgo-sedative effect of each drug</measure>
    <time_frame>during the sedation procedure (from its onset till meeting discharge criteria)</time_frame>
    <description>The duration of sedation: defined as the onset of satisfactory sedation until the time of meeting discharge criteria according to the American Academy of Pediatric Dentistry.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Analgo-sedative effect of each drug.</measure>
    <time_frame>during the sedation procedure (from its onset till meeting discharge criteria)</time_frame>
    <description>Assessment of the most common procedural side effects such as (hypoxia, respiratory depression, agitation, arrhythmia, bradycardia, hypotension or hypertension, shivering, nausea and vomiting) will be recorded.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Amnesic effect of sedative agents.</measure>
    <time_frame>immediately after completion of the dental treatment procedures.</time_frame>
    <description>Anterograde amnesia: will be assessed according to a modification of Bulach et al.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Hemodynamic response of sedative agents.</measure>
    <time_frame>during the sedation procedure (from its onset till meeting discharge criteria)</time_frame>
    <description>Vital sign: Blood pressure (in mmHg) will be monitored using a sphygmomanometer.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Hemodynamic response of sedative agents.</measure>
    <time_frame>during the sedation procedure (from its onset till meeting discharge criteria)</time_frame>
    <description>Vital sign: Heart rate will be counted</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Hemodynamic response of sedative agents.</measure>
    <time_frame>during the sedation procedure (from its onset till meeting discharge criteria)</time_frame>
    <description>Vital sign: Oxygen saturation will be monitored using an oximeter</description>
  </primary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">72</enrollment>
  <condition>Dental Anxiety</condition>
  <arm_group>
    <arm_group_label>Midazolam group (MDZ)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Twenty four pediatric dental patients will receive a procedural sedation session, using Nebulized solution of 0.5 mg/kg Midazolam.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Dexmedetomidine group (DEX)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Twenty four pediatric dental patients will receive a procedural sedation session, using Nebulized solution of 5µg/kg Dexmedetomidine.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Combination of Midazolam and Dexmedetomidine (MDZ/DEX)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Twenty four pediatric dental patients will receive a procedural sedation session, using Nebulized solution of 0.3 mg/kg Midazolam, and 3µg/kg Dexmedetomidine respectively.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Midazolam group (MDZ)</intervention_name>
    <description>IV Ampules of Dormicum 15mg/ 3ml, Hoffman-La Rouche Ltd., Basel, Switzerland</description>
    <arm_group_label>Midazolam group (MDZ)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Dexmedetomidine group (DEX)</intervention_name>
    <description>IV Ampules of Precedex 4mcg/ml, Hospira. Inc., Lake Forest,IL USA.</description>
    <arm_group_label>Dexmedetomidine group (DEX)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Combination of Midazolam and Dexmedetomidine (MDZ/DEX)</intervention_name>
    <description>Combination of Nebulized solution of 0.3 mg/kg Midazolam, and 3µg/kg Dexmedetomidine respectively.(</description>
    <arm_group_label>Combination of Midazolam and Dexmedetomidine (MDZ/DEX)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age range 4-6 years&#xD;
&#xD;
          -  Frankl scale score 2.&#xD;
&#xD;
          -  ASA I or II physical status.&#xD;
&#xD;
          -  Dental intervention under local anesthesia not requiring more than 30 minutes.&#xD;
&#xD;
          -  No previous dental experience.&#xD;
&#xD;
          -  Parent/guardian&quot;s written consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Dental treatment indicated under general anesthesia.&#xD;
&#xD;
          -  Presence of facial deformities.&#xD;
&#xD;
          -  History of neurological or cognitive alterations.&#xD;
&#xD;
          -  Mouth breathers.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>4 Years</minimum_age>
    <maximum_age>6 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Amira A El-Khatib, MSc</last_name>
    <role>Principal Investigator</role>
    <affiliation>Alexandria University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Nadia A Wahba, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Alexandria University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Karin ML Dowidar, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Alexandria University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Tamer AM Ghoneim, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Faculty of Medicine, Alexandria Univerity</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Faculty of Dentistry, Alexandria University</name>
      <address>
        <city>Alexandria</city>
        <zip>21512</zip>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <link>
    <url>http://www.asahq.org/standards-and-guidelines/asa-physical-status-classification-system</url>
    <description>American Society of Anesthesiologists. ASA Physical Status Classification System.</description>
  </link>
  <reference>
    <citation>Zanaty OM, El Metainy SA. A comparative evaluation of nebulized dexmedetomidine, nebulized ketamine, and their combination as premedication for outpatient pediatric dental surgery. Anesth Analg. 2015 Jul;121(1):167-171. doi: 10.1213/ANE.0000000000000728.</citation>
    <PMID>25822924</PMID>
  </reference>
  <reference>
    <citation>Gomes HS, Miranda AR, Viana KA, Batista AC, Costa PS, Daher A, Machado GC, Sado-Filho J, Vieira LA, Correa-Faria P, Hosey MT, Costa LR. Intranasal sedation using ketamine and midazolam for pediatric dental treatment (NASO): study protocol for a randomized controlled trial. Trials. 2017 Apr 11;18(1):172. doi: 10.1186/s13063-017-1919-2.</citation>
    <PMID>28399933</PMID>
  </reference>
  <reference>
    <citation>Guideline for Monitoring and Management of Pediatric Patients Before, During, and After Sedation for Diagnostic and Therapeutic Procedures: Update 2016. Pediatr Dent. 2016 Oct 15;38(5):77-106.</citation>
    <PMID>28206886</PMID>
  </reference>
  <reference>
    <citation>Tobias JD, Leder M. Procedural sedation: A review of sedative agents, monitoring, and management of complications. Saudi J Anaesth. 2011 Oct;5(4):395-410. doi: 10.4103/1658-354X.87270.</citation>
    <PMID>22144928</PMID>
  </reference>
  <reference>
    <citation>Surendar MN, Pandey RK, Saksena AK, Kumar R, Chandra G. A comparative evaluation of intranasal dexmedetomidine, midazolam and ketamine for their sedative and analgesic properties: a triple blind randomized study. J Clin Pediatr Dent. 2014 Spring;38(3):255-61. doi: 10.17796/jcpd.38.3.l828585807482966.</citation>
    <PMID>25095322</PMID>
  </reference>
  <reference>
    <citation>Singh C, Pandey RK, Saksena AK, Chandra G. A comparative evaluation of analgo-sedative effects of oral dexmedetomidine and ketamine: a triple-blind, randomized study. Paediatr Anaesth. 2014 Dec;24(12):1252-9. doi: 10.1111/pan.12493. Epub 2014 Jul 25.</citation>
    <PMID>25065424</PMID>
  </reference>
  <reference>
    <citation>Li BL, Zhang N, Huang JX, Qiu QQ, Tian H, Ni J, Song XR, Yuen VM, Irwin MG. A comparison of intranasal dexmedetomidine for sedation in children administered either by atomiser or by drops. Anaesthesia. 2016 May;71(5):522-8. doi: 10.1111/anae.13407. Epub 2016 Mar 3.</citation>
    <PMID>26936022</PMID>
  </reference>
  <reference>
    <citation>Harbuz DK, O'Halloran M. Techniques to administer oral, inhalational, and IV sedation in dentistry. Australas Med J. 2016 Feb 29;9(2):25-32. doi: 10.4066/AMJ.2015.2543. eCollection 2016.</citation>
    <PMID>26989448</PMID>
  </reference>
  <reference>
    <citation>Greaves A. The use of Midazolam as an Intranasal Sedative in Dentistry. SAAD Dig. 2016 Jan;32:46-9.</citation>
    <PMID>27145560</PMID>
  </reference>
  <reference>
    <citation>Bulach R, Myles PS, Russnak M. Double-blind randomized controlled trial to determine extent of amnesia with midazolam given immediately before general anaesthesia. Br J Anaesth. 2005 Mar;94(3):300-5. doi: 10.1093/bja/aei040. Epub 2004 Nov 26.</citation>
    <PMID>15567810</PMID>
  </reference>
  <reference>
    <citation>Silva FC, Thuler LC. Cross-cultural adaptation and translation of two pain assessment tools in children and adolescents. J Pediatr (Rio J). 2008 Jul-Aug;84(4):344-9. doi: 10.2223/JPED.1809.</citation>
    <PMID>18688551</PMID>
  </reference>
  <reference>
    <citation>Vernon DT, Schulman JL, Foley JM. Changes in children's behavior after hospitalization. Some dimensions of response and their correlates. Am J Dis Child. 1966 Jun;111(6):581-93. doi: 10.1001/archpedi.1966.02090090053003. No abstract available.</citation>
    <PMID>5939538</PMID>
  </reference>
  <reference>
    <citation>Chernik DA, Gillings D, Laine H, Hendler J, Silver JM, Davidson AB, Schwam EM, Siegel JL. Validity and reliability of the Observer's Assessment of Alertness/Sedation Scale: study with intravenous midazolam. J Clin Psychopharmacol. 1990 Aug;10(4):244-51.</citation>
    <PMID>2286697</PMID>
  </reference>
  <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>
  </reference>
  <reference>
    <citation>Canpolat DG, Yildirim MD, Aksu R, Kutuk N, Alkan A, Cantekin K. Intravenous ketamine, propofol and propofol-ketamine combination used for pediatric dental sedation: A randomized clinical study. Pak J Med Sci. 2016 May-Jun;32(3):682-7. doi: 10.12669/pjms.323.9834.</citation>
    <PMID>27375714</PMID>
  </reference>
  <verification_date>January 2020</verification_date>
  <study_first_submitted>January 22, 2019</study_first_submitted>
  <study_first_submitted_qc>January 30, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 1, 2019</study_first_posted>
  <last_update_submitted>January 21, 2020</last_update_submitted>
  <last_update_submitted_qc>January 21, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">January 22, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>University of Alexandria</investigator_affiliation>
    <investigator_full_name>Nourhan M.Aly</investigator_full_name>
    <investigator_title>Clinical Instructor</investigator_title>
  </responsible_party>
  <keyword>Nebulized Dexmedetomidine</keyword>
  <keyword>Nebulized Midazolam</keyword>
  <keyword>Moderate sedation</keyword>
  <keyword>Dental procedural sedation</keyword>
  <keyword>Pediatric dentistry</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>
  <!-- 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/NCT03827408
org study id: IORG0008839
nct id: NCT03827408
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The aim of the study is to evaluate the effect of nebulized Midazolam, Dexmedetomidine, and
      their combination as procedural, moderate sedative agents in preschoolers undergoing dental
      treatment.
Dental anxiety and fear related behaviors are global problems in Pediatric Dentistry.
      Preschoolers represent a dental behavior management problem and there is always a debate over
      the best behavioral management technique for preschoolers undergoing dental treatment.
      Moderate sedation is considered as an acceptable option.

      Children who need treatment under local anesthesia, for thirty minutes will be included in
      the study. A total of 72 uncooperative pediatric dental patients, of age range 4-6 years,
      will be selected from the Pediatric Dentistry and Dental Public Health Department, Faculty of
      Dentistry, Alexandria University, Egypt. The participants will be randomly allocated into 3
      groups that will undergo a procedural sedation session via a nebulizer. Children of group I
      will receive nebulized solution of 0.5 mg/kg Midazolam, Group II will receive nebulized
      solution of 5µg/kg Dexmedetomidine, and Group III will receive a nebulized solution of 0.3
      mg/kg Midazolam and 3µg/kg Dexmedetomidine respectively.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: The participants will be randomly allocated into 3 groups that will undergo a procedural sedation session via a nebulizer. Children of group I will receive nebulized solution of 0.5 mg/kg Midazolam, Group II will receive nebulized solution of 5µg/kg Dexmedetomidine, and Group III will receive a nebulized solution of 0.3 mg/kg Midazolam and 3µg/kg Dexmedetomidine respectively.
primary purpose: Other
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
masking description: The researcher, statistician and participants will be blinded to the intervention group. Only the supervisor and the anesthesiologist will be aware of the allocation group. After data collection is completed, the randomization code will be broken to reveal the allocation group.
measure: Facemask acceptance during drug delivery
time frame: during the sedation procedure
description: It will be evaluated according to Zanaty & Metainy as: poor (terrified, crying and combative), fair (moderate fear of mask not calmed with reassurance), good (slight fear of mask, easily reassured) or excellent (unafraid, cooperative and accepts mask readily)
measure: Effect of sedation on children's future behavior
time frame: after one week in the follow-up session
description: Each child's behavior will be reassessed in the follow-up sessions and compared to that at baseline (before dental treatment) using Frankl scale (ranges from 0-4)
measure: The 'ease of treatment completion' sing separate five-point scales.
time frame: immediately after completion of the dental treatment procedures.
description: This will be measured using separate five-point scales according to Surendar et al: Score 5 indicates an excellent quiet and cooperative child while score 1 indicates Prohibitive active resistance and crying; treatment cannot be rendered.
measure: Post-operative effects of the sedation
time frame: immediately after completion of the dental treatment procedures.
description: This will be assessed according to Modified Vernon et al.
measure: Analgo-sedative effect of each drug
time frame: during the sedation procedure (time taken from drug administration till reaching satisfactory sedation)
description: Onset of Sedation from drug administration until the onset of satisfactory sedation
measure: Analgo-sedative effect of each drug
time frame: during the sedation procedure (after drug administration until reaching satisfactory sedation)
description: Sedation level using Modified Observer's Assessment of Alertness/Sedation Scale. The scale is composed of 4 categories (each has scores ranging from 1-5). The categories are responsiveness, speech, facial expression and eyes. The final score is the sum of scores: the totally awake score is 20/20 and the deeply sedated score is 9/20
measure: Analgo-sedative effect of each drug
time frame: during local anesthesia injection to start the operative procedure
description: The analgesic effect of the sedative drugs will be assessed using "Face, Legs, Activity, Cry, Consolability" scale (FLACC). The scale is scored in a range of 0-10 with 0 representing no pain. The scale has five criteria, which are each assigned a score of 0, 1 or 2.
measure: Analgo-sedative effect of each drug
time frame: during the sedation procedure (from its onset till meeting discharge criteria)
description: The duration of sedation: defined as the onset of satisfactory sedation until the time of meeting discharge criteria according to the American Academy of Pediatric Dentistry.
measure: Analgo-sedative effect of each drug.
time frame: during the sedation procedure (from its onset till meeting discharge criteria)
description: Assessment of the most common procedural side effects such as (hypoxia, respiratory depression, agitation, arrhythmia, bradycardia, hypotension or hypertension, shivering, nausea and vomiting) will be recorded.
measure: Amnesic effect of sedative agents.
time frame: immediately after completion of the dental treatment procedures.
description: Anterograde amnesia: will be assessed according to a modification of Bulach et al.
measure: Hemodynamic response of sedative agents.
time frame: during the sedation procedure (from its onset till meeting discharge criteria)
description: Vital sign: Blood pressure (in mmHg) will be monitored using a sphygmomanometer.
measure: Hemodynamic response of sedative agents.
time frame: during the sedation procedure (from its onset till meeting discharge criteria)
description: Vital sign: Heart rate will be counted
measure: Hemodynamic response of sedative agents.
time frame: during the sedation procedure (from its onset till meeting discharge criteria)
description: Vital sign: Oxygen saturation will be monitored using an oximeter
arm group label: Midazolam group (MDZ)
arm group type: Active Comparator
description: Twenty four pediatric dental patients will receive a procedural sedation session, using Nebulized solution of 0.5 mg/kg Midazolam.
arm group label: Dexmedetomidine group (DEX)
arm group type: Experimental
description: Twenty four pediatric dental patients will receive a procedural sedation session, using Nebulized solution of 5µg/kg Dexmedetomidine.
arm group label: Combination of Midazolam and Dexmedetomidine (MDZ/DEX)
arm group type: Experimental
description: Twenty four pediatric dental patients will receive a procedural sedation session, using Nebulized solution of 0.3 mg/kg Midazolam, and 3µg/kg Dexmedetomidine respectively.
intervention type: Drug
intervention name: Midazolam group (MDZ)
description: IV Ampules of Dormicum 15mg/ 3ml, Hoffman-La Rouche Ltd., Basel, Switzerland
arm group label: Midazolam group (MDZ)
intervention type: Drug
intervention name: Dexmedetomidine group (DEX)
description: IV Ampules of Precedex 4mcg/ml, Hospira. Inc., Lake Forest,IL USA.
arm group label: Dexmedetomidine group (DEX)
intervention type: Drug
intervention name: Combination of Midazolam and Dexmedetomidine (MDZ/DEX)
description: Combination of Nebulized solution of 0.3 mg/kg Midazolam, and 3µg/kg Dexmedetomidine respectively.(
arm group label: Combination of Midazolam and Dexmedetomidine (MDZ/DEX)
criteria: 
gender: All
minimum age: 4 Years
maximum age: 6 Years
healthy volunteers: No
last name: Amira A El-Khatib, MSc
role: Principal Investigator
affiliation: Alexandria University
last name: Nadia A Wahba, PhD
role: Study Director
affiliation: Alexandria University
last name: Karin ML Dowidar, PhD
role: Study Director
affiliation: Alexandria University
last name: Tamer AM Ghoneim, PhD
role: Study Director
affiliation: Faculty of Medicine, Alexandria Univerity
facility: 
country: Egypt
url: http://www.asahq.org/standards-and-guidelines/asa-physical-status-classification-system
description: American Society of Anesthesiologists. ASA Physical Status Classification System.
citation: Zanaty OM, El Metainy SA. A comparative evaluation of nebulized dexmedetomidine, nebulized ketamine, and their combination as premedication for outpatient pediatric dental surgery. Anesth Analg. 2015 Jul;121(1):167-171. doi: 10.1213/ANE.0000000000000728.
PMID: 25822924
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PMID: 28399933
citation: Guideline for Monitoring and Management of Pediatric Patients Before, During, and After Sedation for Diagnostic and Therapeutic Procedures: Update 2016. Pediatr Dent. 2016 Oct 15;38(5):77-106.
PMID: 28206886
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PMID: 22144928
citation: Surendar MN, Pandey RK, Saksena AK, Kumar R, Chandra G. A comparative evaluation of intranasal dexmedetomidine, midazolam and ketamine for their sedative and analgesic properties: a triple blind randomized study. J Clin Pediatr Dent. 2014 Spring;38(3):255-61. doi: 10.17796/jcpd.38.3.l828585807482966.
PMID: 25095322
citation: Singh C, Pandey RK, Saksena AK, Chandra G. A comparative evaluation of analgo-sedative effects of oral dexmedetomidine and ketamine: a triple-blind, randomized study. Paediatr Anaesth. 2014 Dec;24(12):1252-9. doi: 10.1111/pan.12493. Epub 2014 Jul 25.
PMID: 25065424
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PMID: 26936022
citation: Harbuz DK, O'Halloran M. Techniques to administer oral, inhalational, and IV sedation in dentistry. Australas Med J. 2016 Feb 29;9(2):25-32. doi: 10.4066/AMJ.2015.2543. eCollection 2016.
PMID: 26989448
citation: Greaves A. The use of Midazolam as an Intranasal Sedative in Dentistry. SAAD Dig. 2016 Jan;32:46-9.
PMID: 27145560
citation: Bulach R, Myles PS, Russnak M. Double-blind randomized controlled trial to determine extent of amnesia with midazolam given immediately before general anaesthesia. Br J Anaesth. 2005 Mar;94(3):300-5. doi: 10.1093/bja/aei040. Epub 2004 Nov 26.
PMID: 15567810
citation: Silva FC, Thuler LC. Cross-cultural adaptation and translation of two pain assessment tools in children and adolescents. J Pediatr (Rio J). 2008 Jul-Aug;84(4):344-9. doi: 10.2223/JPED.1809.
PMID: 18688551
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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
citation: Canpolat DG, Yildirim MD, Aksu R, Kutuk N, Alkan A, Cantekin K. Intravenous ketamine, propofol and propofol-ketamine combination used for pediatric dental sedation: A randomized clinical study. Pak J Med Sci. 2016 May-Jun;32(3):682-7. doi: 10.12669/pjms.323.9834.
PMID: 27375714
responsible party type: Sponsor-Investigator
investigator affiliation: University of Alexandria
investigator full name: Nourhan M.Aly
investigator title: Clinical Instructor
mesh term: Midazolam
mesh term: Dexmedetomidine