Intranasal Sedation With Dexmedetomidine and Ketamine in Pediatric Dentistry (NASO II)
Condition: Caries of Infancy; Dental Anxiety
Study type: Interventional
Phase: Phase 4

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.
    

Intervention name(s): Dexmedetomidine Hydrochloride; Ketamine Hydrochloride
Intervention type(s): Drug; Drug
Intervention description(s): Dexmedetomidine hydrochloride (PrecedexTM), presented in ampoule containing 2 mL of 100 mcg / mL solution for injection; Dextrocetamine hydrochloride (KetaminTM), presented in a 10 mL vial containing 50 mg / mL solution for injection
Intervention MeSH terms: Dexmedetomidine; Ketamine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment