<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/NCT03290625</url>
  </required_header>
  <id_info>
    <org_study_id>PV0939-2017</org_study_id>
    <nct_id>NCT03290625</nct_id>
  </id_info>
  <brief_title>Intranasal Sedation With Dexmedetomidine and Ketamine in Pediatric Dentistry (NASO II)</brief_title>
  <official_title>Intranasal Sedation With Dexmedetomidine and Ketamine in Pediatric Dentistry (NASO II): Randomized Clinical Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Universidade Federal de Goias</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Fundação de Amparo à Pesquisa do Estado de Goiás (FAPEG)</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Universidade Federal de Goias</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Parallel clinical trial focusing on procedural pediatric sedation in the dental setting.&#xD;
      Children will be randomized to treatment according to a predetermined sequence of&#xD;
      interventions consisting of: 1. intranasal sedation with ketamine-associated dexmedetomidine&#xD;
      (Experimental Group), 2. intranasal sedation with dexmedetomidine as sole drug (Control&#xD;
      Group). Primary outcome is children's behavior during the dental treatment. Secondary&#xD;
      outcomes are: children's pain, memory and stress (salivary cortisol and melatonin);&#xD;
      perception of the accompanying adult, dentist and child about dental sedation;&#xD;
      cost-effectiveness of this type of sedation; psychosocial variables; children's quality of&#xD;
      life.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This proposal aims to determine the most effective pharmacological regimen in the treatment&#xD;
      of child pain and anxiety during outpatient dental procedures. Advancement in this field is a&#xD;
      reflection, on the one hand, of the use of new and more effective routes of drug&#xD;
      administration, such as the intranasal route using atomizers with uniform dispersion of the&#xD;
      administered jet and, on the other hand, the use of new sedative drugs, such as&#xD;
      dexmedetomidine. This is a randomized, parallel, triple-masked clinical trial, using a&#xD;
      research protocol with the objectives: 1) To evaluate the efficacy (behavior, pain, memory&#xD;
      and stress) of a sedative regimen intranasally mucosal atomizer device (MAD) using a sedative&#xD;
      drug (ketamine) and an innovative drug (dexmedetomidine) in the sedation of children from 2&#xD;
      to 6 years of age undergoing dental treatment - our hypothesis is that the use of&#xD;
      dexmedetomidine intranasally association with ketamine is more effective than dexmedetomidine&#xD;
      itself in isolation; 2) To analyze the level of cortisol and salivary melatonin (stress)&#xD;
      according to each sedative protocol and its association with clinical variables; 3) Identify&#xD;
      adverse events with the new protocol; 4) To evaluate the association between the child's&#xD;
      behavior and psychosocial variables; 5) To verify the impact of treatment under dental&#xD;
      sedation on the quality of life related to the oral health of the child. The research will be&#xD;
      carried out in the Faculty of Dentistry of the Federal University of Goias, in the Center of&#xD;
      Studies in Dental Sedation (NESO), Goiânia, Goias. A non-probabilistic sample of 88 children&#xD;
      aged 2 to 6 years (alpha 0.05, 80% power) who present dental caries with restorative need,&#xD;
      American Society of Anesthesiologists I or II, patent nasal airways (Mallampati index I or II&#xD;
      and obstruction by hypertrophy of tonsils ≤ 50% and effective nasal breathing), in addition&#xD;
      to non-cooperative behavior with the examination or a dental procedure. Children with&#xD;
      neuropathies, those using growth hormone and / or those who exhibit severe adverse events&#xD;
      during sedation will be excluded. Children will be randomized to treatment according to a&#xD;
      predetermined sequence of interventions consisting of: 1. intranasal sedation with&#xD;
      ketamine-associated dexmedetomidine (Experimental Group), 2. intranasal sedation with&#xD;
      dexmedetomidine as sole drug (Control Group). Pediatricians and anesthesiologists will be&#xD;
      aware of the randomized intervention, because of safety concerns for the child, in the case&#xD;
      of serious adverse events with or without immediate use of antagonists; the other staff&#xD;
      members and the child's companion (s) will be &quot;masked&quot;. The examination and intervention&#xD;
      sessions will be filmed in high definition for later analysis of the behavior and pain&#xD;
      according to different scales consecrated and / or validated. In addition, the children will&#xD;
      be submitted to four saliva collections to analyze the levels of cortisol and melatonin&#xD;
      (stress-related hormones). Other variables of secondary outcome are: perception of the&#xD;
      accompanying adult, dentist and child about dental sedation and cost-effectiveness of this&#xD;
      type of sedation, psychosocial variables, quality of life. The data will be analyzed by&#xD;
      descriptive and bivariate statistics. This proposal will bring benefits in the vast field of&#xD;
      health sedation by having original design, using drugs and promising routes, with national&#xD;
      and international impact. The project is inserted in a research line that presents experience&#xD;
      history and impact publications by the proponent team, as well as involving students of&#xD;
      scientific initiation, master's, doctorate, and postdoctoral studies, being developed by a&#xD;
      multidisciplinary team. There is a clear expectation of generating results with high impact&#xD;
      production, besides the possibility of immediate application in the public and private&#xD;
      sectors of a highly effective sedative regime, minimizing the need to refer patients to&#xD;
      general anesthesia.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 9, 2017</start_date>
  <completion_date type="Actual">March 5, 2020</completion_date>
  <primary_completion_date type="Actual">September 12, 2019</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>Children's behavior according to observational scale</measure>
    <time_frame>From the beginning to the end of the dental treatment, which should last around 30-40 minutes</time_frame>
    <description>Children's behavior during the dental treatment under sedation according to the observational scale 'Ohio State University Behavioral Rating Scale' (OSUBRS) as assessed by trained and calibrated observers in the video files of the procedure</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Acceptance of intranasal administration according to observation</measure>
    <time_frame>From the beginning to the end of the intranasal sedative administration, which should less than one minute each</time_frame>
    <description>Acceptance of intranasal sedative regimen administration using a pre-defined form; trained and calibrated observers will assess children's acceptance through symptoms such as crying, need for physical restraint, and others</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Memory of the procedure through questionnaire</measure>
    <time_frame>From the children's arrival at the dental clinic until discharge, and then on the day after, up to 36 hours</time_frame>
    <description>Children's memory of facts that happened just before and after the administration of the sedative, through a questionnaire exploring toys showed and procedures occurred just before and during the procedure</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Salivary cortisol according to ELISA</measure>
    <time_frame>From the night before the procedure until the end of the dental procedure under sedation, up to 24 hours</time_frame>
    <description>Children's salivary cortisol related to the dental treatment under sedation assessed through ELISA</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Salivary melatonin according to ELISA</measure>
    <time_frame>From the night before the procedure until the end of the dental procedure under sedation, up to 24 hours</time_frame>
    <description>Children's salivary melatonin related to the dental treatment under sedation assessed through ELISA</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain according to the FLACC scale</measure>
    <time_frame>From the beginning to the end of the dental treatment, which should last around 30-40 minutes</time_frame>
    <description>Children's pain during the dental treatment under sedation, assessed by trained and calibrated observers using the Faces, Legas, Activity, Consolability and Crying scale (FLACC) in digital video files related to the procedure</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Accompanying person perception through VAS</measure>
    <time_frame>Just after the end of the child's dental procedure, while in the recovery anesthetic room, an average of 60 minutes</time_frame>
    <description>Accompanying person perception on the child's sedation through Visual Analogue Scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pediatric dentist perception through VAS</measure>
    <time_frame>Just after the end of the child's dental procedure, an average of 60 minutes</time_frame>
    <description>Pediatric dentist perception on the child's sedation through Visual Analogue Scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Child's perception through qualitative interview</measure>
    <time_frame>One week after the dental sedation procedure</time_frame>
    <description>Child's perception on the dental procedure under sedation, according to a qualitative interview following a semistructured guide</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adverse events</measure>
    <time_frame>During the procedure and within the 24 hours after</time_frame>
    <description>Post-operative adverse events related to the dental sedation procedure</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Child's dental anxiety and sedation efficacy, according to the Venham's picture test</measure>
    <time_frame>Fifteen minutes before the administration of the sedative</time_frame>
    <description>Association of child's dental anxiety with the outcome of the procedural sedation, using the Venham Picture Test</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Child's dental behavior in the reception and sedation efficacy, according to the Sharath Scale</measure>
    <time_frame>Fifteen minutes before the administration of the sedative</time_frame>
    <description>Association of child's dental behavior with the outcome of the procedural sedation, using the Sharath scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Parents' anxiety and sedation efficacy, according to the STAI</measure>
    <time_frame>On the day of the inclusion of the child in the RCT, an average of 30 minutes before the child's dental exam</time_frame>
    <description>Association of parental overall anxiety with the outcome of the procedural sedation, using short form of the State-Trate Anxiety Inventory (STAI)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Parents' dental anxiety and sedation efficacy, according to the Corah Scale</measure>
    <time_frame>On the day of the inclusion of the child in the RCT, an average of 30 minutes before the child's dental exam</time_frame>
    <description>Association of parental dental anxiety with the outcome of the procedural sedation, using Dental Anxiety Scale by Corah</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Parents' overall stress and sedation efficacy, according to the Lipp Inventory</measure>
    <time_frame>On the day of the inclusion of the child in the RCT, an average of 30 minutes before the child's dental exam</time_frame>
    <description>Association of parental stress with the outcome of the procedural sedation, using the according to the &quot;Inventário de Sintomas de Stress para Adultos de Lipp - ISSL&quot; (Lipp Adult Stress Symptoms Inventory - ISSL)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Procedural dental sedation impact according to the B-ECOHIS</measure>
    <time_frame>Two weeks and three months after the completion of the dental treatment</time_frame>
    <description>Impact of dental treatment under sedation on the oral health related quality of life related to the child and respective family, using the questionnaire B-ECOHIS</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Economic analysis</measure>
    <time_frame>After the completion of data collection for the primary outcome, an average of 4 years</time_frame>
    <description>Cost-effectiveness analysis of the two sedative regimens</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">12</enrollment>
  <condition>Caries of Infancy</condition>
  <condition>Dental Anxiety</condition>
  <arm_group>
    <arm_group_label>DexKet</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Intranasal DEXMEDETOMIDINE (2.0 mcg/kg, maximum 100 mcg) + KETAMINE (1.0 mg/kg, maximum 100 mg)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Dex</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>DEXMEDETOMIDINE (2.5 mcg/kg, maximum 100 mcg)</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Dexmedetomidine Hydrochloride</intervention_name>
    <description>Dexmedetomidine hydrochloride (PrecedexTM), presented in ampoule containing 2 mL of 100 mcg / mL solution for injection</description>
    <arm_group_label>Dex</arm_group_label>
    <arm_group_label>DexKet</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ketamine Hydrochloride</intervention_name>
    <description>Dextrocetamine hydrochloride (KetaminTM), presented in a 10 mL vial containing 50 mg / mL solution for injection</description>
    <arm_group_label>DexKet</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Children born to term, whose physical condition is categorized as American Society of&#xD;
             Anesthesiologists I (healthy) or II (mild and controlled systemic disease - persistent&#xD;
             asthma, for example)&#xD;
&#xD;
          -  Children with a low risk of airway obstruction (Mallampati less than 2 and / or tonsil&#xD;
             hypertrophy occupying less than 50% of the oropharynx)&#xD;
&#xD;
          -  Children without neurological or cognitive alterations and who do not use medications&#xD;
             that may compromise cognitive functions&#xD;
&#xD;
          -  Children with caries requiring dental restoration&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Children with positive behavior in the consultation without sedation&#xD;
&#xD;
          -  Children with facial deformity&#xD;
&#xD;
          -  Children using corticosteroid&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Months</minimum_age>
    <maximum_age>83 Months</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Luciane Costa, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Universidade Federal de Goias</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Dental School</name>
      <address>
        <city>Goiania</city>
        <state>Goias</state>
        <zip>74605220</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>September 14, 2017</study_first_submitted>
  <study_first_submitted_qc>September 17, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 25, 2017</study_first_posted>
  <last_update_submitted>June 26, 2020</last_update_submitted>
  <last_update_submitted_qc>June 26, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 30, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Universidade Federal de Goias</investigator_affiliation>
    <investigator_full_name>Luciane Ribeiro de Rezende Sucasas da Costa</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dexmedetomidine</mesh_term>
    <mesh_term>Ketamine</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03290625
org study id: PV0939-2017
nct id: NCT03290625
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Parallel clinical trial focusing on procedural pediatric sedation in the dental setting.
      Children will be randomized to treatment according to a predetermined sequence of
      interventions consisting of: 1. intranasal sedation with ketamine-associated dexmedetomidine
      (Experimental Group), 2. intranasal sedation with dexmedetomidine as sole drug (Control
      Group). Primary outcome is children's behavior during the dental treatment. Secondary
      outcomes are: children's pain, memory and stress (salivary cortisol and melatonin);
      perception of the accompanying adult, dentist and child about dental sedation;
      cost-effectiveness of this type of sedation; psychosocial variables; children's quality of
      life.
This proposal aims to determine the most effective pharmacological regimen in the treatment
      of child pain and anxiety during outpatient dental procedures. Advancement in this field is a
      reflection, on the one hand, of the use of new and more effective routes of drug
      administration, such as the intranasal route using atomizers with uniform dispersion of the
      administered jet and, on the other hand, the use of new sedative drugs, such as
      dexmedetomidine. This is a randomized, parallel, triple-masked clinical trial, using a
      research protocol with the objectives: 1) To evaluate the efficacy (behavior, pain, memory
      and stress) of a sedative regimen intranasally mucosal atomizer device (MAD) using a sedative
      drug (ketamine) and an innovative drug (dexmedetomidine) in the sedation of children from 2
      to 6 years of age undergoing dental treatment - our hypothesis is that the use of
      dexmedetomidine intranasally association with ketamine is more effective than dexmedetomidine
      itself in isolation; 2) To analyze the level of cortisol and salivary melatonin (stress)
      according to each sedative protocol and its association with clinical variables; 3) Identify
      adverse events with the new protocol; 4) To evaluate the association between the child's
      behavior and psychosocial variables; 5) To verify the impact of treatment under dental
      sedation on the quality of life related to the oral health of the child. The research will be
      carried out in the Faculty of Dentistry of the Federal University of Goias, in the Center of
      Studies in Dental Sedation (NESO), Goiânia, Goias. A non-probabilistic sample of 88 children
      aged 2 to 6 years (alpha 0.05, 80% power) who present dental caries with restorative need,
      American Society of Anesthesiologists I or II, patent nasal airways (Mallampati index I or II
      and obstruction by hypertrophy of tonsils ≤ 50% and effective nasal breathing), in addition
      to non-cooperative behavior with the examination or a dental procedure. Children with
      neuropathies, those using growth hormone and / or those who exhibit severe adverse events
      during sedation will be excluded. Children will be randomized to treatment according to a
      predetermined sequence of interventions consisting of: 1. intranasal sedation with
      ketamine-associated dexmedetomidine (Experimental Group), 2. intranasal sedation with
      dexmedetomidine as sole drug (Control Group). Pediatricians and anesthesiologists will be
      aware of the randomized intervention, because of safety concerns for the child, in the case
      of serious adverse events with or without immediate use of antagonists; the other staff
      members and the child's companion (s) will be "masked". The examination and intervention
      sessions will be filmed in high definition for later analysis of the behavior and pain
      according to different scales consecrated and / or validated. In addition, the children will
      be submitted to four saliva collections to analyze the levels of cortisol and melatonin
      (stress-related hormones). Other variables of secondary outcome are: perception of the
      accompanying adult, dentist and child about dental sedation and cost-effectiveness of this
      type of sedation, psychosocial variables, quality of life. The data will be analyzed by
      descriptive and bivariate statistics. This proposal will bring benefits in the vast field of
      health sedation by having original design, using drugs and promising routes, with national
      and international impact. The project is inserted in a research line that presents experience
      history and impact publications by the proponent team, as well as involving students of
      scientific initiation, master's, doctorate, and postdoctoral studies, being developed by a
      multidisciplinary team. There is a clear expectation of generating results with high impact
      production, besides the possibility of immediate application in the public and private
      sectors of a highly effective sedative regime, minimizing the need to refer patients to
      general anesthesia.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Outcomes Assessor)
measure: Children's behavior according to observational scale
time frame: From the beginning to the end of the dental treatment, which should last around 30-40 minutes
description: Children's behavior during the dental treatment under sedation according to the observational scale 'Ohio State University Behavioral Rating Scale' (OSUBRS) as assessed by trained and calibrated observers in the video files of the procedure
measure: Acceptance of intranasal administration according to observation
time frame: From the beginning to the end of the intranasal sedative administration, which should less than one minute each
description: Acceptance of intranasal sedative regimen administration using a pre-defined form; trained and calibrated observers will assess children's acceptance through symptoms such as crying, need for physical restraint, and others
measure: Memory of the procedure through questionnaire
time frame: From the children's arrival at the dental clinic until discharge, and then on the day after, up to 36 hours
description: Children's memory of facts that happened just before and after the administration of the sedative, through a questionnaire exploring toys showed and procedures occurred just before and during the procedure
measure: Salivary cortisol according to ELISA
time frame: From the night before the procedure until the end of the dental procedure under sedation, up to 24 hours
description: Children's salivary cortisol related to the dental treatment under sedation assessed through ELISA
measure: Salivary melatonin according to ELISA
time frame: From the night before the procedure until the end of the dental procedure under sedation, up to 24 hours
description: Children's salivary melatonin related to the dental treatment under sedation assessed through ELISA
measure: Pain according to the FLACC scale
time frame: From the beginning to the end of the dental treatment, which should last around 30-40 minutes
description: Children's pain during the dental treatment under sedation, assessed by trained and calibrated observers using the Faces, Legas, Activity, Consolability and Crying scale (FLACC) in digital video files related to the procedure
measure: Accompanying person perception through VAS
time frame: Just after the end of the child's dental procedure, while in the recovery anesthetic room, an average of 60 minutes
description: Accompanying person perception on the child's sedation through Visual Analogue Scale
measure: Pediatric dentist perception through VAS
time frame: Just after the end of the child's dental procedure, an average of 60 minutes
description: Pediatric dentist perception on the child's sedation through Visual Analogue Scale
measure: Child's perception through qualitative interview
time frame: One week after the dental sedation procedure
description: Child's perception on the dental procedure under sedation, according to a qualitative interview following a semistructured guide
measure: Adverse events
time frame: During the procedure and within the 24 hours after
description: Post-operative adverse events related to the dental sedation procedure
measure: Child's dental anxiety and sedation efficacy, according to the Venham's picture test
time frame: Fifteen minutes before the administration of the sedative
description: Association of child's dental anxiety with the outcome of the procedural sedation, using the Venham Picture Test
measure: Child's dental behavior in the reception and sedation efficacy, according to the Sharath Scale
time frame: Fifteen minutes before the administration of the sedative
description: Association of child's dental behavior with the outcome of the procedural sedation, using the Sharath scale
measure: Parents' anxiety and sedation efficacy, according to the STAI
time frame: On the day of the inclusion of the child in the RCT, an average of 30 minutes before the child's dental exam
description: Association of parental overall anxiety with the outcome of the procedural sedation, using short form of the State-Trate Anxiety Inventory (STAI)
measure: Parents' dental anxiety and sedation efficacy, according to the Corah Scale
time frame: On the day of the inclusion of the child in the RCT, an average of 30 minutes before the child's dental exam
description: Association of parental dental anxiety with the outcome of the procedural sedation, using Dental Anxiety Scale by Corah
measure: Parents' overall stress and sedation efficacy, according to the Lipp Inventory
time frame: On the day of the inclusion of the child in the RCT, an average of 30 minutes before the child's dental exam
description: Association of parental stress with the outcome of the procedural sedation, using the according to the "Inventário de Sintomas de Stress para Adultos de Lipp - ISSL" (Lipp Adult Stress Symptoms Inventory - ISSL)
measure: Procedural dental sedation impact according to the B-ECOHIS
time frame: Two weeks and three months after the completion of the dental treatment
description: Impact of dental treatment under sedation on the oral health related quality of life related to the child and respective family, using the questionnaire B-ECOHIS
measure: Economic analysis
time frame: After the completion of data collection for the primary outcome, an average of 4 years
description: Cost-effectiveness analysis of the two sedative regimens
arm group label: DexKet
arm group type: Experimental
description: Intranasal DEXMEDETOMIDINE (2.0 mcg/kg, maximum 100 mcg) + KETAMINE (1.0 mg/kg, maximum 100 mg)
arm group label: Dex
arm group type: Active Comparator
description: DEXMEDETOMIDINE (2.5 mcg/kg, maximum 100 mcg)
intervention type: Drug
intervention name: Dexmedetomidine Hydrochloride
description: Dexmedetomidine hydrochloride (PrecedexTM), presented in ampoule containing 2 mL of 100 mcg / mL solution for injection
arm group label: Dex
arm group label: DexKet
intervention type: Drug
intervention name: Ketamine Hydrochloride
description: Dextrocetamine hydrochloride (KetaminTM), presented in a 10 mL vial containing 50 mg / mL solution for injection
arm group label: DexKet
criteria: 
gender: All
minimum age: 20 Months
maximum age: 83 Months
healthy volunteers: Accepts Healthy Volunteers
last name: Luciane Costa, PhD
role: Principal Investigator
affiliation: Universidade Federal de Goias
facility: 
country: Brazil
responsible party type: Principal Investigator
investigator affiliation: Universidade Federal de Goias
investigator full name: Luciane Ribeiro de Rezende Sucasas da Costa
investigator title: Professor
mesh term: Dexmedetomidine
mesh term: Ketamine
sharing ipd: Undecided