Sedation Versus Protective Stabilization for Pediatric Dental Treatment

Universidade Federal de Goias

Status and phase: Enrolling; Phase 4

Conditions: Dental Caries in Children; Child Behavior

Treatments: Procedure: Protective stabilization; Drug: Midazolam Hcl 2Mg/Ml Syrup; Drug: Ketamine 50 MG/ML

Study type: Interventional

Funder types: Other

Identifiers

NCT04119180

PI03925-2019

424339/2018-8 (Other Grant/Funding Number)

Details and patient eligibility

About

There is a lack of evidence on the effectiveness of moderate sedation in pediatric dentistry, compared to protective stabilization, which remains routinely used in the Brazilian context despite moral questions. The objective of this prospective nonrandomized clinical trial is to evaluate the effectiveness of the use of moderate sedation, compared to the protective stabilization, in the dental care of children with fear / anxiety and / or dental behavior problem, and associated factors. The study will be carried out in outpatient clinics of the Dental Schools of the Federal University of Goiás (UFG) and University of São Paulo (USP), with the support of professors from King's College London through the partnership CEDACORE - Children Experiencing Dental Anxiety: Collaboration on Research and Education. Participants will be 152 children under 7 years of age with dental caries, who need specialized dental treatment due to a history of non-cooperation with dental care. The interventions to be compared are moderate sedation with oral administration of ketamine and midazolam (UFG) and protective stabilization (USP). The primary endpoint 'behavior / anxiety of the child during treatment will be assessed using the Ohio State University Behavioral Rating Scale. The secondary outcomes are: dental behavioral and anxiety evolution of the child, child' pain during procedure, impact on the quality of life related to oral health, parents and dentists' satisfaction and stress, adverse events for sedated participants, longevity of composite and glass ionomer cement restorations, chronotype and physiological stress of these children. A cost-efficacy analysis will be produced at the end of the study from the perspective of the Sistema Único de Saúde. Additionally, at the end of 36 months, the investigators expect to contribute to the identification of psychosocial aspects related to dental behavior problems in children in early childhood. It is important to highlight the perspective of technological innovation, with the creation of a digital platform that will allow the registration of data related to the dental care of children worldwide and favor analyzes in the methodology of data science.

Enrollment: 152 estimated patients

Sex: All

Ages: 1 to 7 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Children presenting cavities that need dental restoration
• ASA I (healthy) or II (mild and controlled systemic disease - persistent asthma, for example) children (ASA, 2015)
• Medical history without neurological or cognitive impairment
• Children who do not use medicines that may impair cognitive functions
• Children at low risk for airway obstruction (Mallampati less than 2 and / or tonsil hypertrophy occupying less than 50% of the oropharynx) (Mallampati et al., 1985)

Exclusion criteria

• Children with positive or definitely positive behavior (Frankl et al. 1962) in the dental examination session
• Non-attendance at the first intervention appointment after three scheduling attempts
• Chronic use of systemic corticosteroids

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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152 participants in 2 patient groups

Sedation

Experimental group

Description:

The child receives sedatives approved for use in an outpatient setting, directed by a doctor, to accomplish the dental treatment.

Treatment:

Drug: Ketamine 50 MG/ML

Drug: Midazolam Hcl 2Mg/Ml Syrup

Control

Other group

Description:

The child does not receive sedatives. As s/he exhibits negative behavior for the dental procedure, s/he will be restrained by a family member and dental team.

Treatment:

Procedure: Protective stabilization