Sedation versus protective stabilization for dental treatment of children with caries and challenging behavior at the dentist (CHOOSE): a study protocol for a non-randomized clinical trial.

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.

Clinical findings in congenital infection by Zika virus: a retrospective study in a reference hospital in Central-West Brazil.

BACKGROUND: An increased number of congenital Zika virus infections with neurological and musculoskeletal malformations have been diagnosed worldwide, however, there are still several gaps in the knowledge about this infection, its associated mechanism, timing of transmission, and description of throughout findings of signs and symptoms, which is described in this paper. The purpose of this study is to describe aspects of congenital Zika syndrome (CZS) beyond the central nervous system comprising detailed delineation of all the other clinical findings. METHODS: A retrospective research developed using electronic medical records. We analyzed the files of 69 children with an initial diagnosis of microcephaly by Zika vírus who were born in 2015, 2016 and 2017, treated during the period from 2016 to 2017. RESULTS: The newborns presented several neurological and musculoskeletal malformations, eye damage, hearing impairment and other malformations. CONCLUSIONS: The present study has significant impact for health care teams following lactents with Congenital Zika Syndrome.

Crossover Studies of Pediatric Dental Sedation are Inappropriate.

Crossover studies continue to be published in spite of warnings about their inherent risks in relation to behavioral outcomes. This study took the opportunity of access to secondary data analysis in order to demonstrate the impact of a crossover design on the outcomes of randomized clinical trials aimed at the behavior of children during dental treatment. We evaluated the effect of the sequence of sedative administration, the sedative and the participant's age on the behavior of children undergoing two sequential dental visits. Eighteen uncooperative healthy young children were equally randomly assigned to: (G1) 1.0 mg/kg oral midazolam (first session) and oral placebo (second session); (G2) oral placebo (first) and 1.0 mg/kg oral midazolam (second). One trained observer assessed children's behavior. Data were analyzed by three-way mixed ANOVA. Both midazolam [mean(SD); 71.7%(16.5)] and placebo [48.6%(33.1)] produced more struggling behavior when they were administered in the first session compared to the second one (p=0.001). For the placebo, children aged 2-3 years exhibited more struggling behavior [G1 54.9%(36.2); G2 80.5%(8.3)] than those aged 4-5 years (p=0.04). Also, the reduction of percentage of struggling behavior was higher in G1 for older children (76.2%) and in G2 for younger children (32.9%). There were significant interactions between drug and sequence of administration, and between drug and age. The results of our study confirm the conventional wisdom that crossover study design is inappropriate to evaluate children's behavior/anxiety related-dental treatment under sedation and the results of crossover studies of dental sedation should be treated with extreme caution.

Crossover studies of pediatric dental sedation are inappropriate

Abstract Crossover studies continue to be published in spite of warnings about their inherent risks in relation to behavioral outcomes. This study took the opportunity of access to secondary data analysis in order to demonstrate the impact of a crossover design on the outcomes of randomized clinical trials aimed at the behavior of children during dental treatment. We evaluated the effect of the sequence of sedative administration, the sedative and the participant's age on the behavior of children undergoing two sequential dental visits. Eighteen uncooperative healthy young children were equally randomly assigned to: (G1) 1.0 mg/kg oral midazolam (first session) and oral placebo (second session); (G2) oral placebo (first) and 1.0 mg/kg oral midazolam (second). One trained observer assessed children's behavior. Data were analyzed by three-way mixed ANOVA. Both midazolam [mean(SD); 71.7%(16.5)] and placebo [48.6%(33.1)] produced more struggling behavior when they were administered in the first session compared to the second one (p=0.001). For the placebo, children aged 2-3 years exhibited more struggling behavior [G1 54.9%(36.2); G2 80.5%(8.3)] than those aged 4-5 years (p=0.04). Also, the reduction of percentage of struggling behavior was higher in G1 for older children (76.2%) and in G2 for younger children (32.9%). There were significant interactions between drug and sequence of administration, and between drug and age. The results of our study confirm the conventional wisdom that crossover study design is inappropriate to evaluate children's behavior/anxiety related-dental treatment under sedation and the results of crossover studies of dental sedation should be treated with extreme caution.

Resumo Pouco se sabe sobre o impacto de um delineamento cruzado nos desfechos de ensaios clínicos randomizados voltados ao comportamento de crianças durante tratamento odontológico. Este estudo objetivou avaliar o efeito da sequência de administração do sedativo, da droga em si e da idade dos participantes no comportamento de crianças que receberam duas consultas odontológicas consecutivas. Dezoito crianças saudáveis não colaboradoras, 2-5 anos de idade, foram randomizadas em dois grupos: G1 - 1,0 mg/kg midazolam oral (primeira sessão) e placebo oral (segunda sessão); G2 - placebo (primeira) e 1,0 mg/kg midazolam oral (segunda). Um observador treinado avaliou o comportamento infantil. Os dados foram analisados por ANOVA de três fatores (alfa=0,05). Midazolam [média(DP); 71,7%(16,5)] e placebo [48,6%(33,1)] resultaram em mais comportamento não cooperativo quando administrados na primeira sessão comparado com a segunda (p=0,001). Com o uso do placebo, crianças de 2-3 anos de idade exibiram mais comportamento não cooperativo [G1 54,9%(36,2); G2 80,5%(8,3)] que as de 4-5 anos de idade (p=0,04). Além disso, a porcentagem de redução do comportamento não cooperativo foi maior em crianças mais velhas em G1 (76,2%) e em crianças mais novas em G2 (32,9%). Considerando a avaliação do comportamento infantil sob sedação, a primeira sessão odontológica influenciou a segunda visita. Os resultados deste estudo confirmam a especulação de que o delineamento cruzado é inadequado para avaliar o comportamento odontológico relacionado à ansiedade/comportamento infantil; os resultados dos ensaios cruzados de sedação odontológica devem ser tratados com extrema cautela.

Randomized clinical trial on the efficacy of intranasal or oral ketamine-midazolam combinations compared to oral midazolam for outpatient pediatric sedation.

PURPOSE: The optimal sedative regime that provides the greatest comfort and the lowest risk for procedural sedation in young children remains to be determined. The aim of this randomized, blinded, controlled, parallel-design trial was to evaluate the efficacy of intranasal ketamine and midazolam as the main component of the behavioral guidance approach for preschoolers during dental treatment. MATERIALS AND METHODS: Children under seven years of age, with caries and non-cooperative behavior, were randomized into three groups: (KMIN) intranasal ketamine and midazolam; (KMO) oral ketamine and midazolam; or (MO) oral midazolam. The dental sedation appointments were videotaped, and the videos were analyzed using the Ohio State University Behavioral Rating Scale (OSUBRS) to determine the success of the sedation in each group. Intra- and postoperative adverse events were recorded. Data analysis involved descriptive statistics and non-parametric tests (P < 0.05, IBM SPSS). RESULTS: Participants were 84 children (28 per group; 43 boys), with a mean age of 3.1 years (SD 1.2). Children's baseline and the dental sedation session characteristics were balanced among groups. The success of the treatment as assessed by the dichotomous variable 'quiet behavior for at least 60% of the session length' was: KMIN 50.0% (n = 14; OR 2.10, 95% CI 0.71 to 6.30), KMO 46.4% (n = 13; OR 1.80, 95% CI 0.62 to 5.40), MO 32.1% (n = 9) (P = 0.360). Adverse events were minor, occurred in 37 of 84 children (44.0%), and did not differ among groups (P = 0.462). CONCLUSION: All three regimens provided moderate dental sedation with minor adverse events, with marked variability in the behavior of children during dental treatment. The potential benefit of the ketamine-midazolam combination should be further investigated in studies with larger samples. TRIAL REGISTRATION: ClinicalTrials.gov, identifier: NCT02447289. Registered on 11 May 2015, named "Midazolam and Ketamine Effect Administered Through the Nose for Sedation of Children for Dental Treatment (NASO)."

Developmental defects of enamel in the deciduous incisors of infants born preterm: Prospective cohort.

OBJECTIVE: Developmental defects of enamel (DDE) in preterm infants still require clarification and may favour dental caries, lower food intake and greater difficulty with weight-height gain. We evaluated factors associated with DDE in preterm infants. SUBJECTS AND METHODS: In this prospective cohort study, we monitored 54 prematurely born infants from birth to 24 months of age. Trained and calibrated dentists examined the oral cavity of these children to identify and categorize DDE. Information on perinatal variables was collected from the infants' medical records and interviews with their mothers. The data were analysed using Student's t test, a chi-squared test and Pearson's product-moment correlation coefficient. RESULTS: A total of 46.3% of the 54 children presented DDE, which was observed more frequently in the left hemiarch in children born extremely (<28 weeks of gestation) or very preterm (28 to <32 weeks; RR = 2.2; 95% CI 1.3-3.6), with very low birthweight (<1,500 g; RR = 2.0; 95% CI 1.1-3.5), who were admitted to the neonatal intensive care unit (RR = 1.3; 95% CI 1.0-1.7), and who were intubated (RR = 1.6; 95% CI 1.1-2.2). CONCLUSIONS: The high incidence of incisor enamel defects, particularly on the left side, was related to higher risk prematurity and to local trauma from intubation.

Neurological Complications of Congenital Zika Virus Infection.

BACKGROUND: In utero Zika virus infection resulted in many newborns with congenital defects; this public health issue was followed by unprecedented scientific productivity in this field. Many questions remain about congenital Zika virus infection and its maternal transmission, pathogenesis, clinical events, and the resulting neurological damage. There are few review articles that synthesize the current knowledge of congenital neurological complications as well as the gaps in the pediatric literature. OBJECTIVE: We review the full range of data on neurological complications in the newborns and infants born to Zika virus-infected women. METHODS: A research question (PCC: Population, newborns and infants of infected mothers; Concept, neurological outcomes at birth; Context, congenital Zika virus infection) was created to guide our review in searching several databases: PubMed, Lilacs, CINAHL, Cochrane Library, and OpenGrey literature. A total of 34 articles were included in the final review. RESULTS: Central nervous system calcifications, mainly at the cortical-subcortical junction, were the most prevalent neurological birth defects related to Zika infection (104/112, 92.9% from seven studies). Also, microcephaly occurred in 39.7% of all infected infants (1561/3931 patients in all the studies) and ventriculomegaly and/or hydrocephalus occurred in 63.1% (157/249 patients analyzed in 12 studies). A total of 10 articles detailed ocular findings, including macular lesions, focal pigment mottling of the retina, chorioretinal atrophy, optic nerve abnormalities, cataract, microphthalmia, and strabismus, among others. CONCLUSIONS: Neurological and related malformations are common lesions in individuals with congenital Zika syndrome. Long-term follow-up studies in this field are lacking.

TRANSLATION, CROSS-CULTURAL ADAPTATION AND PRELIMINARY EVALUATION OF THE BRAZILIAN VERSIONOF THE PAIN CATASTROPHIZING SCALE-PARENTS. / TRADUÇÃO, ADAPTAÇÃO TRANSCULTURAL E AVALIAÇÃO PRELIMINAR DA PAIN CATASTROPHIZING SCALE-PARENTS PARA USO NO BRASIL.

OBJECTIVE: In Brazil, there is no scale to assess parental catastrophizing about their child's pain. This study aimed to translate and cross-culturally adapt the Pain Catastrophizing Scale-Parents to the Brazilian Portuguese language, as well as to preliminarily evaluate its psychometric properties among parents/guardians of children with and without a toothache. METHODS: A cross-sectional study was conducted with 237 parents/other relatives of 237 children. Across-cultural adaptation of the scale into Brazilian Portuguese was carried out according to the universalistic approach. To assess the reliability and validity of the scale, parents/other relatives reported on the child's toothache and filled out the Brazilian versions of the Pain Catastrophizing Scale-Parents and the Dental Discomfort Questionnaire. RESULTS: There was semantic equivalence with the original version after minor modifications. TheCronbach's alpha for the 13 items of the scale was 0.83, and the respective test-retest intraclass correlation coefficients ranged from 0.63 to 0.97. The scores obtained from the Pain Catastrophizing Scale-Parents and the Dental Discomfort Questionnaire had a low correlation (rho=0.25; p<0.001). Thetotal score of the Pain Catastrophizing Scale-Parents differed significantly (p<0.001) in children with a toothache at night (median: 3.0, 25-75 percentile: 25.0-35.5) compared to those who did not have a toothache at night (25.5; 20.0-31.0). CONCLUSIONS: The Brazilian version of the Pain Catastrophizing Scale-Parents was acceptable in this preliminary evaluation and can be used in Brazilian clinical and research practice.

OBJETIVO: No Brasil, não há escala que avalie a catastrofização dos pais sobre a dor das crianças. O objetivo deste estudo foi traduzir e adaptar transculturalmente o Pain Catastrophizing Scale-Parents para a língua portuguesa do Brasil e avaliar preliminarmente as propriedades psicométricas de pais/outros parentes de crianças com e sem dor de dente. MÉTODOS: Foi realizado um estudo transversal com 237 pais/outros parentes de 237 crianças. A adaptação transcultural da escala para o português brasileiro foi feita conforme a abordagem universalista. Para avaliar a confiabilidade e a validade da escala, os pais/outros parentes fizeram um relato sobre a dor de dente da criança e preencheram as versões brasileiras da Escala de Catastrofização da Dor-Pais e o Questionário de Desconforto Dentário. RESULTADOS: Houve equivalência semântica com a versão original após pequenas modificações. O alfa de Cronbach para os 13 itens da escala foi 0,83 e os respectivos coeficientes de correlação intraclasse do teste-reteste variaram de 0,63 a 0,97. Os escores obtidos na Escala de Catastrofização da Dor-Pais e no Questionário de Desconforto Dentário apresentaram baixa correlação (rho=0,25; p<0,001). O escore total da Escala de Catastrofização da Dor-Pais diferiu significativamente (p<0,001) em crianças com dor de dente à noite (mediana: 30,0; percentil 25-75: 25,0-35,5) quando comparado com o daquelas sem dor de dente (25,5; 20,0-31,0). CONCLUSÕES: A versão brasileira da Escala de Catastrofização da Dor-Pais apresentou características aceitáveis nesta avaliação preliminar e pode ser utilizada no Brasil tanto na prática clínica quanto em pesquisas.

Tradução, adaptação transcultural e avaliação preliminar da pain catastrophizing scale-parents para uso no brasil / Translation, cross-cultural adaptation and preliminary evaluation of the brazilian versionof the pain catastrophizing scale-parents

RESUMO Objetivo: No Brasil, não há escala que avalie a catastrofização dos pais sobre a dor das crianças. O objetivo deste estudo foi traduzir e adaptar transculturalmente o Pain Catastrophizing Scale-Parents para a língua portuguesa do Brasil e avaliar preliminarmente as propriedades psicométricas de pais/outros parentes de crianças com e sem dor de dente. Métodos: Foi realizado um estudo transversal com 237 pais/outros parentes de 237 crianças. A adaptação transcultural da escala para o português brasileiro foi feita conforme a abordagem universalista. Para avaliar a confiabilidade e a validade da escala, os pais/outros parentes fizeram um relato sobre a dor de dente da criança e preencheram as versões brasileiras da Escala de Catastrofização da Dor-Pais e o Questionário de Desconforto Dentário. Resultados: Houve equivalência semântica com a versão original após pequenas modificações. O alfa de Cronbach para os 13 itens da escala foi 0,83 e os respectivos coeficientes de correlação intraclasse do teste-reteste variaram de 0,63 a 0,97. Os escores obtidos na Escala de Catastrofização da Dor-Pais e no Questionário de Desconforto Dentário apresentaram baixa correlação (rho=0,25; p<0,001). O escore total da Escala de Catastrofização da Dor-Pais diferiu significativamente (p<0,001) em crianças com dor de dente à noite (mediana: 30,0; percentil 25-75: 25,0-35,5) quando comparado com o daquelas sem dor de dente (25,5; 20,0-31,0). Conclusões: A versão brasileira da Escala de Catastrofização da Dor-Pais apresentou características aceitáveis nesta avaliação preliminar e pode ser utilizada no Brasil tanto na prática clínica quanto em pesquisas.

ABSTRACT Objective: In Brazil, there is no scale to assess parental catastrophizing about their child's pain. This study aimed to translate and cross-culturally adapt the Pain Catastrophizing Scale-Parents to the Brazilian Portuguese language, as well as to preliminarily evaluate its psychometric properties among parents/guardians of children with and without a toothache. Methods: A cross-sectional study was conducted with 237 parents/other relatives of 237 children. Across-cultural adaptation of the scale into Brazilian Portuguese was carried out according to the universalistic approach. To assess the reliability and validity of the scale, parents/other relatives reported on the child's toothache and filled out the Brazilian versions of the Pain Catastrophizing Scale-Parents and the Dental Discomfort Questionnaire. Results: There was semantic equivalence with the original version after minor modifications. TheCronbach's alpha for the 13 items of the scale was 0.83, and the respective test-retest intraclass correlation coefficients ranged from 0.63 to 0.97. The scores obtained from the Pain Catastrophizing Scale-Parents and the Dental Discomfort Questionnaire had a low correlation (rho=0.25; p<0.001). Thetotal score of the Pain Catastrophizing Scale-Parents differed significantly (p<0.001) in children with a toothache at night (median: 3.0, 25-75 percentile: 25.0-35.5) compared to those who did not have a toothache at night (25.5; 20.0-31.0). Conclusions: The Brazilian version of the Pain Catastrophizing Scale-Parents was acceptable in this preliminary evaluation and can be used in Brazilian clinical and research practice.

The use of probiotics for improving lipid profiles in dyslipidemic individuals: an overview protocol.

BACKGROUND: Dyslipidemia is a major risk factor in triggering cardiovascular events, which can lead to the death of millions of people around the world. Thus, several pharmacological and non-pharmacological therapeutic strategies have been developed in recent decades with the objective of improving lipid profiles, including the use of probiotics. Therefore, the purpose of this protocol is to describe the steps that will guide the construction of an overview to demonstrate the scientific evidence of the efficacy of probiotics in improving the lipid profile of dyslipidemic individuals and to propose specific recommendations regarding their use. METHODS: The search will be conducted in the following databases: MEDLINE/PubMed, EMBASE, PROSPERO, Cochrane Library, CINAHL, JBI Database of Systematic Reviews and Implementation Reports, Google Scholar, and CADTH. Reviewers will select systematic evaluations and data analyses from randomized clinical trials that evaluated the effects of probiotics on lipid profiles. The studies will be analyzed for methodology quality by the AMSTAR 2 tool and risk of bias by ROBIS. The data will be extracted by three independent reviewers based on a data extraction sheet, which will include the most relevant variables for the analysis and interpretation of the results. The variables will be categorized and described in narrative form or in tables. DISCUSSION: There are some systematic reviews about the use of probiotics to prevent and/or treat dyslipidemia; however, their outcomes related to the ability of probiotics to improve lipid profiles are conflicting. So, an overview on this topic is needed to clarify this important issue. SYSTEMATIC REVIEW REGISTRATION: PROSPERO CRD42017080328.

What is the level of evidence for the amnestic effects of sedatives in pediatric patients? A systematic review and meta-analyses.

BACKGROUND: Studies have suggested that benzodiazepines are amnestic drug par excellence, but when taken together, what level of evidence do they generate? Are other sedatives as amnestic as benzodiazepines? The aim of this study was to assess the level of scientific evidence for the amnestic effect of sedatives in pediatric patients who undergo health procedures. METHODS: The literature was searched to identify randomized controlled trials that evaluated anterograde and retrograde amnesia in 1-19-year-olds who received sedative drugs during health procedures. Electronic databases, including PubMed, Scopus and Cochrane Library besides clinical trial registries and grey literature were searched. Two independent reviewers performed data extraction and risk of bias assessment using the Cochrane Collaboration's Tool. The meta-analyses were performed by calculating relative risk (RR) to 95% confidence intervals (CI). The quality of the evidence was assessed using Grading of Recommendations Assessment, Development and Evaluation approach. RESULTS: Fifty-four studies were included (4,168 participants). A higher occurrence of anterograde amnesia was observed when benzodiazepines, the most well-studied sedatives (n = 47), were used than when placebo was used (n = 12) (RR = 3.10; 95% CI: 2.30-4.19, P<0.001; I2 = 14%), with a moderate level of evidence. Higher doses of alpha2-adrenergic agonists (clonidine/dexmedetomidine) produced more anterograde amnesia than lower doses (n = 2) (RR = 1.83; 95% CI: 1.03-3.25; P = 0.038; I2 = 0%), with a low level of evidence; benzodiazepines' amnestic effects were not dose-dependent (n = 3) (RR = 1.54; 95% CI: 0.96-2.49; P = 0.07; I2 = 12%) but the evidence was low. A qualitative analysis showed that retrograde amnesia did not occur in 8 out of 10 studies. CONCLUSIONS: In children, moderate evidence support that benzodiazepines induce anterograde amnesia, whereas the evidence for other sedatives is weak and based on isolated and small studies. Further clinical trials focused on the amnesia associated with non-benzodiazepine sedatives are therefore needed. TRIAL REGISTRATION: PROSPERO CRD42015017559.

Intranasal sedation using ketamine and midazolam for pediatric dental treatment (NASO): study protocol for a randomized controlled trial.

BACKGROUND: Uncooperative children may need to receive dental treatment under sedation, which is indicated when nonpharmacological behavior guidance is unsuccessful. There are randomized controlled trials (RCTs) comparing different sedative protocols for dental procedures; however, the evidence for superiority of one form over another is weak. The primary aim of this study is to investigate the efficacy of intranasally administered ketamine plus midazolam for the dental treatment of children. METHODS: We have designed a three-armed, parallel RCT to assess intranasal sedation using ketamine/midazolam in terms of the following measures: efficacy, safety, and cost-effectiveness. Two- to 6-year-old healthy children, referred for dental treatment in a dental sedation center in Brazil due to uncooperative behavior and requiring restorative dental procedures, will be recruited. Each child will be randomly assigned to one of the three groups: A - Intranasal administration of ketamine (4.0 mg/kg, maximum 100 mg) and midazolam (0.2 mg/kg, maximum 5.0 mg); B - Oral administration of ketamine (4.0 mg/kg, maximum 100 mg) and midazolam (0.5 mg/kg, maximum 20 mg); and C - Oral administration of midazolam (1.0 mg/kg, maximum 20 mg). The primary outcome is the child's behavior assessed through an observational scale using digital videos of the restorative dental treatment under sedation. The secondary outcomes are as follows: acceptance of sedative administration; memory of intraoperative events; the child's stress; adverse events; the child's pain during the procedure; the parent's, dentists', and child's perceptions of sedation; and economic analysis. Measures will be taken at baseline and drug administration and during and after the dental procedure. The necessary sample size was estimated to be 84 children after a blinded interim analysis of the first 30 cases. DISCUSSION: This study will provide data that can substantially add to science and pediatric dentistry as it examines the effect of sedative regimes from different perspectives (outcomes). TRIAL REGISTRATION: ClinicalTrials.gov, identifier: NCT02447289 . Registered on 11 May 2015, named "Midazolam and Ketamine Effect Administered Through the Nose for Sedation of Children for Dental Treatment (NASO)."

Does sevoflurane add to outpatient procedural sedation in children? A randomised clinical trial.

BACKGROUND: There is little evidence concerning the effect of sevoflurane in outpatient procedural sedation, especially in children. We hypothesised that the addition of sevoflurane to a sedation regimen improves children's behaviour with minimal adverse events. METHODS: This is a randomised, triple-blind clinical trial conducted on an outpatient basis. Participants were 27 healthy children aged 4 to 6 years, who previously refused dental treatment with non-pharmacologic methods. All participants received oral midazolam (0.5 mg/kg, maximum 20 mg) and oral ketamine (3 mg/kg, maximum 50 mg) and, in addition: Group MK - 100% oxygen; Group MKS - inhalational sevoflurane at a sedative dose (final expired concentration between 0.3 and 0.4%). Dental appointments were video recorded for assessment of the children's sleep patterns, crying, movements, and overall behaviour during the procedure with the Houpt scale. Intra- and post-operative adverse events were systematically reported. Data were analysed by bivariate analyses in the IBM SPSS v. 19, at a significance level of 5%. RESULTS: MK (n = 13) and MKS (n = 14) did not differ regarding the Houpt scores (P > 0.05), but 53.8% of children in the MK group showed hysterical and continuous crying at the time of the local anaesthesia injection, compared to 7.1% of children in the MKS group (P = 0.01; phi = 0.5). There was a trend toward less crying and movement over time during the dental appointment in the MKS group (P = 0.48). Minor adverse events were observed in 10 MK children and 4 MKS children (P = 0.01). CONCLUSIONS: The addition of sevoflurane to oral midazolam-ketamine improved the children's crying behaviour during local anaesthetic administration, and did not increase the occurrence of adverse events. TRIAL REGISTRATION: Clinical Trials NCT02284204 . Registered 5 October 2014.

Moderate sedation helps improve future behavior in pediatric dental patients - a prospective study.

There is little evidence on the long-term effects of pharmacological management in children undergoing dental treatment. This study aimed to assess children's behavior in consecutive dental sessions following oral rehabilitation using different pharmacological regimens for behavioral control. Participants were preschoolers who were previously treated for caries under one of the following: no sedative, oral sedation with midazolam, oral sedation with midazolam/ketamine, or general anesthesia. The children's behavior in the follow-up sessions was assessed using the Ohio State University Behavioral Rating Scale (OSUBRS); higher scores represented less cooperative behavior (range 5-20). Follow-up assessments were conducted on 50 children under four years old for up to 29 months. Data were analyzed by the Friedman/Wilcoxon tests and Cox regression model. OSUBRS mean (standard deviation) scores for the whole sample decreased from 11.9 (5.4) before treatment to 6.8 (3.2) at the final recall session (p < 0.001). Moderate sedation with midazolam (OR 2.9, 95%CI 1.2-6.9) or midazolam/ketamine (OR 4.3, 95%CI 1.6-11.4) improved children's future behavior. The general anesthesia group (n = 4) had a small sample size and the results should be considered with caution. Although invasive dental treatment negatively affected the child's behavior in the dental chair, they became more cooperative over time. Moderately sedated children showed better prospective behavior than those in the non-sedation group.

Professional dental prophylaxis increases salivary cortisol in children with dental behavioural management problems: a longitudinal study.

BACKGROUND: Dental procedures may cause stress and increase the salivary cortisol levels. It is important to known if apparently simple procedures such as professional dental prophylaxis at low speed (DP) are stressful for children with dental behaviour management problems (DBMP) to help with behaviour guidance strategies. This longitudinal study aimed to evaluate if DP changes a physiological marker of stress (salivary cortisol) in children with DBMP who were referred to dental treatment under sedation. METHODS: One paediatric dentist carried out a DP with rubber cup and pumice followed by dental examination in 39 children aged 2-5 years, prior to the dental sedation appointment. Children's saliva was collected at three different moments: upon waking (UW), on arrival at the dental office reception area (RA) and 25 min after the dental prophylaxis (DP). The saliva samples were analysed using an enzyme immunoassay kit. The Wilcoxon test was used in paired comparison (P < 0.05). RESULTS: Salivary cortisol levels decreased from UW (0.34; 0.15-0.54) to RA (0.14; 0.08-0.56) (P = 0.019) and increased from RA to DP (0.25; 0.06-1.48) (P = 0.008). Higher salivary cortisol levels were observed at DP when compared to RA in children who did not have previous dental treatment (P = 0.007), had toothache (P = 0.006), presented some protest behaviour during DP (P = 0.008), or needed protective stabilisation by parents for the dental examination (P = 0.005). CONCLUSIONS: Paediatric dentists should be aware that even simple procedures such as professional dental prophylaxis are related to stress in young children.

How Do Observational Scales Correlate the Ratings of Children's Behavior during Pediatric Procedural Sedation?

Background. There is little information regarding the ability of observational scales to properly assess children's behavior during procedural sedation. Aim. To evaluate the characteristics of the Houpt scales, the Ohio State University Behavioral Rating Scale (OSUBRS) and the Venham Behavior Rating Scale when applied to preschool children undergoing conscious dental sedation. Design. This study included 27 children, 4-6 years old with early childhood caries that participated in a clinical trial (NCT02284204) that investigated two sedative regimes using oral midazolam/ketamine. Dental appointments were video-recorded; five calibrated observers assessed 1,209 minutes of video recording to score the children's behavior, following the instructions of the investigated scales. Data were analyzed by descriptive analysis and Spearman correlation tests (P < 0.05). Results. The Houpt overall behavior and the Venham scale were highly correlated (rho = -0.87; P < 0.001). OSUBRS scores were better correlated with Houpt overall behavior and Venham ratings, when compared to Houpt scores in the categories for movement and crying. Conclusions. The Houpt overall behavior and the Venham scores are global scales that properly measure children's behavior during dental sedation. Continuous assessment with OSUBRS through videos has a chance to give more precise data, while the Houpt categories can easily demonstrate children's behavior during procedures.