Clinical trial NCT03290625: Intranasal Sedation With Dexmedetomidine and Ketamine in Pediatric Dentistry (NASO II)
Official title: Intranasal Sedation With Dexmedetomidine and Ketamine in Pediatric Dentistry (NASO II): Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Caries of Infancy
Dental Anxiety
Lead sponsor: Universidade Federal de Goias
Sponsor class: OTHER
Collaborators: name: Fundação de Amparo à Pesquisa do Estado de Goiás (FAPEG)
First posted: 2017-09-25
Enrollment: 12
Sex: ALL
Minimum age (years): 20
Maximum age (years): 83
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Children's behavior according to observational scale
timeFrame: From the beginning to the end of the dental treatment, which should last around 30-40 minutes
Secondary outcomes:
measure: Acceptance of intranasal administration according to observation
timeFrame: From the beginning to the end of the intranasal sedative administration, which should less than one minute each
measure: Memory of the procedure through questionnaire
timeFrame: From the children's arrival at the dental clinic until discharge, and then on the day after, up to 36 hours
measure: Salivary cortisol according to ELISA
timeFrame: From the night before the procedure until the end of the dental procedure under sedation, up to 24 hours
measure: Salivary melatonin according to ELISA
timeFrame: From the night before the procedure until the end of the dental procedure under sedation, up to 24 hours
measure: Pain according to the FLACC scale
timeFrame: From the beginning to the end of the dental treatment, which should last around 30-40 minutes
measure: Accompanying person perception through VAS
timeFrame: Just after the end of the child's dental procedure, while in the recovery anesthetic room, an average of 60 minutes
measure: Pediatric dentist perception through VAS
timeFrame: Just after the end of the child's dental procedure, an average of 60 minutes
measure: Child's perception through qualitative interview
timeFrame: One week after the dental sedation procedure
measure: Adverse events
timeFrame: During the procedure and within the 24 hours after
measure: Child's dental anxiety and sedation efficacy, according to the Venham's picture test
timeFrame: Fifteen minutes before the administration of the sedative
measure: Child's dental behavior in the reception and sedation efficacy, according to the Sharath Scale
timeFrame: Fifteen minutes before the administration of the sedative
measure: Parents' anxiety and sedation efficacy, according to the STAI
timeFrame: On the day of the inclusion of the child in the RCT, an average of 30 minutes before the child's dental exam
measure: Parents' dental anxiety and sedation efficacy, according to the Corah Scale
timeFrame: On the day of the inclusion of the child in the RCT, an average of 30 minutes before the child's dental exam
measure: Parents' overall stress and sedation efficacy, according to the Lipp Inventory
timeFrame: On the day of the inclusion of the child in the RCT, an average of 30 minutes before the child's dental exam
measure: Procedural dental sedation impact according to the B-ECOHIS
timeFrame: Two weeks and three months after the completion of the dental treatment
measure: Economic analysis
timeFrame: After the completion of data collection for the primary outcome, an average of 4 years
Other outcomes:
Locations:
city: Goiania
country: Brazil
facility: Dental School
state: Goias
Study officials:
affiliation: Universidade Federal de Goias
name: Luciane Costa, PhD
role: PRINCIPAL_INVESTIGATOR
References: