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

The incidence of peri-procedural amnesia following procedural sedation in children is unclear and difficult to determine. This study aimed to apply quantitative and qualitative approaches to better understand amnesia following dental sedation of children. After Institutional Review Board Approval, children scheduled for sedation for dental procedures with oral midazolam (OM), oral midazolam and ketamine (OMK), or intranasal midazolam and ketamine (IMK) were recruited for examination of peri-procedural amnesia. Amnesia during the dental session was assessed using a three-stage method, using identification of pictures and an animal toy. On the day following the sedation, primary caregivers answered two questions about their children’s memory. One week later, the children received a semi-structured interview. Behavior and level of sedation during the dental session were recorded. Quantitative data were analyzed using descriptive statistics and comparison tests. Qualitative data were analyzed using content analysis. Triangulation was used. Thirty-five children (age: 36 to 76 months) participated in the quantitative analysis. Most children showed amnesia for the dental procedure (82.9%, n = 29/35) and remembered receiving the sedation (82.1%, n = 23/28 for oral administration; 59.3%, n = 16/27 for intranasal administration). The occurrence of amnesia for the dental procedure was slightly higher in the oral midazolam group compared with the other groups (44.8%, n = 13/29 for OM, 13.8%, n = 4/29 for OMK, and 41.4%, n = 12/29 for IMK). Twenty-eight children participated in the qualitative approach. The major theme identified was that some children could remember their procedures in detail. We conclude that peri-procedural amnesia of the dental procedure was common following sedation.