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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)." [ABSTRACT FROM AUTHOR]

Background: Some sedatives used in children and adolescents can affect memory function. Memory impairment of traumatic experience can minimize the chance of future psychological trauma. Knowledge about the potential of different sedatives to produce amnesia can help in the decision-making process of choosing a sedative regimen. The aim of this systematic review is to evaluate the effect of different sedatives on memory of perioperative events in children and adolescents. Methods/design: Electronic databases and other sources, such as trial registers, gray literature, and conference abstracts will be searched. Randomized controlled trials will be included that assess memory of perioperative events in children and adolescents 2-19 years old receiving sedative drugs as premedication or as agents for procedural sedation in a medical or dental settings. The outcomes will be loss of memory after and before sedative administration (anterograde and retrograde amnesia). Two independent reviewers will perform screening, study selection, and data extraction. Disagreement at all levels will be resolved by consensus or by involving a third reviewer. Assessment of the risk of bias of included studies will be performed according to "Cochrane Collaboration's Tool for Assessing Risk of Bias in Randomized Trials." Clinical and methodological heterogeneity across studies will be evaluated to determine if it is possible to combine or not combine study results in a meta-analysis. Discussion: To the best of our knowledge, there is no systematic review that specifically addresses this question. Findings from the review will be useful in the decision-making process about the best sedative for minimizing recall of the medical/dental event and possible psychological trauma. [ABSTRACT FROM AUTHOR]

Background A rigorous cross-cultural adaptation process of an existing instrument could be the best option for health measuring in different cultures, instead of developing a new tool, and prior to psychometric and validation testing. The Dental Discomfort Questionnaire (DDQ), a validated instrument for assessing toothache in young children, has not been cross-culturally adapted so far. This study aimed to explore the detailed phases of the cross-cultural adaptation process of a pain assessment tool, presenting the example of the DDQ Brazilian-Portuguese adapted version. Methods The study design was based on the universalist approach, which consists of a sequential analysis to assess the relevant phases of a cross-cultural process before testing the measures of the instrument: conceptual, item, semantic, and operational equivalences. Systematic information was gathered from the literature, expert discussions, translations, and pre-testing through cognitive interviews with Brazilian population. Results Detailed description of the three major phases for a cross-cultural adaptation process was given. Notes of the changes done in the structure of the presented instrument (DDQ) were specifically pointed at each phase. Conceptual and item analyses showed that there are similarities in the DDQ construct between the original and Brazilian cultures that require minor modifications. Translations and back-translations allowed the development of the preliminary Brazilian-Portuguese version of the DDQ, which was tested and underwent other minor changes to improve its comprehensibility. Conclusions Describing the phases was important to show how changes are made in a cross-cultural adaptation process of an instrument. This also could help researchers in adapting similar pediatric pain assessments to different cultures. A Brazilian-Portuguese version of the DDQ was presented. [ABSTRACT FROM AUTHOR]

Background The Dental Discomfort Questionnaire (DDQ) is an observational instrument intended to measure dental discomfort and/or pain in children under 5 years of age. This study aimed to validate a previously cross-culturally adapted version of DDQ in a Brazilian children sample. Methods Participants included 263 children (58.6% boys, mean age 43.5 months) that underwent a dental examination to assess dental caries, and their parent that filled out the cross-culturally adapted DDQ on their behalf. Exploratory factor analysis (principal component analysis form) and psychometric tests were done to assess instrument's dimensionality and reliability. Results Exploratory factor analysis revealed a multidimensional instrument with 3 domains: 'eating and sleeping problems' (Cronbach's alpha 0.81), 'earache problems' (alpha 0.75), and 'problems with brushing teeth' (alpha 0.78). The assessment had excellent stability (weighted-kappa varying from 0.68 to 0.97). Based on the factor analysis, the model with all 7 items included only in the first domain (named DDQ-B) was further explored. The items and total median score of the DDQ-B were related to parent-reported toothache and the number of decayed teeth, demonstrating good construct and discriminant validities. Conclusions DDQ-B was proven a reliable pain assessment tool to screen this group of Brazilian children for caries-related toothache, with good psychometric properties. [ABSTRACT FROM AUTHOR]

Background: Relative analgesia (RA), defined as the use of inhalation sedation with nitrous oxide and oxygen, is one of the most common pharmacological behavior management techniques used to provide sedation and analgesia for dental patients. This study aimed to assess RA licensed Brazilian dentists' practices and opinions about nitrous oxide/oxygen sedation in the dental setting. Methods: A cross sectional national survey was conducted with 281 dentists who were certified to perform RA, using an electronically mailed self-administered questionnaire containing closed questions about their practices and opinions regarding RA. Practice and opinion were individually analyzed by descriptive statistics. Non-parametric tests assessed the relationships between RA practice and independent variables. To test the interplay between practices and opinions, a k-means clusters analysis was used to divide the group for statistical comparisons. Results: The response rate was 45.2%. Women made up 64.6% of the respondents, the mean age was 39.1 years (SD = 9.8), and the mean time since graduation in dentistry was 16 years (SD = 9.7). Seventy-seven percent of respondents reported the use of RA in clinical practice, most of them 'sometimes' (53.5%), and focusing more on adult patients. Patients with certain physical or mental deficiencies were indications associated with RA practice. 'Equipment acquisition' (p<0.001) and 'living in Southeast and South regions' (p<0.02) were also associated with RA practice. The scores for dentists' opinions ranged from 15 to 41 points (mean 29.2, SD = 5.6), based on nine items scored from 1 to 5. Two clusters representing more favorable (n = 65) and less favorable (n = 55) opinions were established. Dentists who were women (p = 0.04), practiced RA in dental settings (p<0.01) or practiced it frequently (p<0.001), had more favorable opinions about RA. Conclusion: Most of the RA licensed Brazilian dentists interviewed currently use RA. Current practice of RA and frequency of use determined the degree of favorable opinion about this inhalation sedation among this group of respondents. [ABSTRACT FROM AUTHOR]