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Intranasal Sedation With Dexmedetomidine and Ketamine in Pediatric Dentistry (NASO II)

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ClinicalTrials.gov Identifier: NCT03290625
Recruitment Status : Completed
First Posted : September 25, 2017
Last Update Posted : June 30, 2020
Sponsor:
Collaborator:
Fundação de Amparo à Pesquisa do Estado de Goiás (FAPEG)
Information provided by (Responsible Party):
Luciane Ribeiro de Rezende Sucasas da Costa, Universidade Federal de Goias

Tracking Information
First Submitted Date  ICMJE September 14, 2017
First Posted Date  ICMJE September 25, 2017
Last Update Posted Date June 30, 2020
Actual Study Start Date  ICMJE November 9, 2017
Actual Primary Completion Date September 12, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 17, 2017)
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 ]
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 17, 2017)
  • 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 ]
    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
  • 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 ]
    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
  • 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 ]
    Children's salivary cortisol related to the dental treatment under sedation assessed through ELISA
  • 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 ]
    Children's salivary melatonin related to the dental treatment under sedation assessed through ELISA
  • 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 ]
    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
  • 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 ]
    Accompanying person perception on the child's sedation through Visual Analogue Scale
  • Pediatric dentist perception through VAS [ Time Frame: Just after the end of the child's dental procedure, an average of 60 minutes ]
    Pediatric dentist perception on the child's sedation through Visual Analogue Scale
  • Child's perception through qualitative interview [ Time Frame: One week after the dental sedation procedure ]
    Child's perception on the dental procedure under sedation, according to a qualitative interview following a semistructured guide
  • Adverse events [ Time Frame: During the procedure and within the 24 hours after ]
    Post-operative adverse events related to the dental sedation procedure
  • Child's dental anxiety and sedation efficacy, according to the Venham's picture test [ Time Frame: Fifteen minutes before the administration of the sedative ]
    Association of child's dental anxiety with the outcome of the procedural sedation, using the Venham Picture Test
  • 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 ]
    Association of child's dental behavior with the outcome of the procedural sedation, using the Sharath scale
  • 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 ]
    Association of parental overall anxiety with the outcome of the procedural sedation, using short form of the State-Trate Anxiety Inventory (STAI)
  • 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 ]
    Association of parental dental anxiety with the outcome of the procedural sedation, using Dental Anxiety Scale by Corah
  • 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 ]
    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)
  • Procedural dental sedation impact according to the B-ECOHIS [ Time Frame: Two weeks and three months after the completion of the dental treatment ]
    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
  • Economic analysis [ Time Frame: After the completion of data collection for the primary outcome, an average of 4 years ]
    Cost-effectiveness analysis of the two sedative regimens
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Intranasal Sedation With Dexmedetomidine and Ketamine in Pediatric Dentistry (NASO II)
Official Title  ICMJE Intranasal Sedation With Dexmedetomidine and Ketamine in Pediatric Dentistry (NASO II): Randomized Clinical Trial
Brief Summary 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.
Detailed Description 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Caries of Infancy
  • Dental Anxiety
Intervention  ICMJE
  • Drug: Dexmedetomidine Hydrochloride
    Dexmedetomidine hydrochloride (PrecedexTM), presented in ampoule containing 2 mL of 100 mcg / mL solution for injection
  • Drug: Ketamine Hydrochloride
    Dextrocetamine hydrochloride (KetaminTM), presented in a 10 mL vial containing 50 mg / mL solution for injection
Study Arms  ICMJE
  • Experimental: DexKet
    Intranasal DEXMEDETOMIDINE (2.0 mcg/kg, maximum 100 mcg) + KETAMINE (1.0 mg/kg, maximum 100 mg)
    Interventions:
    • Drug: Dexmedetomidine Hydrochloride
    • Drug: Ketamine Hydrochloride
  • Active Comparator: Dex
    DEXMEDETOMIDINE (2.5 mcg/kg, maximum 100 mcg)
    Intervention: Drug: Dexmedetomidine Hydrochloride
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 11, 2020)
12
Original Estimated Enrollment  ICMJE
 (submitted: September 17, 2017)
182
Actual Study Completion Date  ICMJE March 5, 2020
Actual Primary Completion Date September 12, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Children born to term, whose physical condition is categorized as American Society of Anesthesiologists I (healthy) or II (mild and controlled systemic disease - persistent asthma, for example)
  • Children with a low risk of airway obstruction (Mallampati less than 2 and / or tonsil hypertrophy occupying less than 50% of the oropharynx)
  • Children without neurological or cognitive alterations and who do not use medications that may compromise cognitive functions
  • Children with caries requiring dental restoration

Exclusion Criteria:

  • Children with positive behavior in the consultation without sedation
  • Children with facial deformity
  • Children using corticosteroid
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Months to 83 Months   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Brazil
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03290625
Other Study ID Numbers  ICMJE PV0939-2017
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Current Responsible Party Luciane Ribeiro de Rezende Sucasas da Costa, Universidade Federal de Goias
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Universidade Federal de Goias
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Fundação de Amparo à Pesquisa do Estado de Goiás (FAPEG)
Investigators  ICMJE
Principal Investigator: Luciane Costa, PhD Universidade Federal de Goias
PRS Account Universidade Federal de Goias
Verification Date June 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP