Background: There is a lack of evidence on the effectiveness of moderate sedation in pediatric dentistry, compared to protective stabilization, which remains routinely used in Brazil despite moral questions. This prospective non-randomized clinical trial's objective is to evaluate the effectiveness of moderate sedation, compared to the protective stabilization, in the dental care of children with dental behavior management problems.
Methods: Participants will be 152 children under seven years of age with early childhood caries (ECC) who need specialized dental treatment due to a history of challenging behavior during dental care. The interventions to be compared are moderate sedation with oral administration of ketamine and midazolam and protective stabilization. The primary endpoint will be the child's behavior during treatment assessed using the Ohio State University Behavioral Rating Scale (OSUBRS). The secondary outcomes are (A) child's - behavior according to the visual analogue scale, anxiety, pain, and physiological stress; (B) parent's - satisfaction and anxiety; (C) family and child - impact on oral health-related quality of life (OHRQoL); (D) dentist's - satisfaction and stress; (E) procedure - adverse events of the intervention and dental treatment longevity. A cost-effectiveness analysis will be performed from the perspective of the Brazilian Unified Health System (SUS).
Discussion: Considering the primary outcome, this study hypothesis is that sedated children have better behavior during dental treatment than children whose behavior was managed by protective stabilization without sedation. Additionally, at the end of 12 months, we expect to identify participants' reported outcomes and objective measures related to dental behavior in early childhood. Trial registration Clinicaltrials.gov registration NCT04119180 on October 8th, 2019. https://clinicaltrials.gov/ct2/show/NCT04119180.
Keywords: Child behavior; Conscious sedation; Cost-effectiveness analysis; Dental anxiety; Dental care for children; Dental caries; Physical restraint.