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.

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.

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

Abstract 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.

Evaluation of clinical and laboratory variables associated with anemia in pediatric patients on hemodialysis / Avaliação de variáveis clínicas e laboratoriais associadas à anemia em pacientes pediátricos em hemodiálise

OBJECTIVE: To identify the occurrence of anemia in pediatric patients on hemodialysis and the association between hemoglobin levels and anemia in CKD-related variables. METHODS: This was a retrospective study. Patients aged up to 18 years with chronic kidney disease undergoing hemodialysis at this service between January of 2009 and December of 2010 were selected. Clinical and laboratory data were obtained from medical records. Statistical analysis was performed with chi-squared test, Student's t-test and general estimating equations (GEE) using SPSS 20.0, assuming a significance level of 5%. RESULTS: A total of 357 medical records depicting the monthly evolution of 29 patients were analyzed. The most common etiology for chronic kidney disease was malformations of the genitourinary tract (28%). Hemoglobin showed a mean (standard deviation) value of 9.20 (1.8) g/dL, with the occurrence of anemia in 65.3% of cases. Anemia was associated with hospitalization; antibiotic use; transfusion; use of intravenous iron hydroxide; low values of creatinine, hematocrit, and albumin; and high values of ferritin, aluminum, and equilibrated Kt/V (p < 0.05). The odds ratio for anemia with the use of intravenous iron hydroxide was 0.36 (95% CI: 0.25 to 0.89), i.e., a 2.78-fold higher chance of developing anemia without the use of this medication. CONCLUSIONS: Anemia predominated in children and adolescents with chronic kidney disease; intravenous iron hydroxide use was a protective factor. .

OBJETIVO: Identificar a ocorrência de anemia entre pacientes pediátricos em hemodiálise e a associação entre os valores de hemoglobina e variáveis relacionadas à anemia na DRC. MÉTODOS: Estudo retrospectivo. Selecionados pacientes até 18 anos com doença renal crônica em hemodiálise no serviço entre janeiro de 2009 e dezembro de 2010. Verificados prontuários para coleta de dados clínicos e laboratoriais. Análise estatística com testes de qui-quadrado, t de Student e General Estimating Equations (GEE) em programa Statistical Package for the Social Sciences 20.0, assumindo-se nível de significância de 5%. RESULTADOS: Analisadas 357 fichas de evolução médica mensal de 29 pacientes. A etiologia mais frequente para a doença renal crônica foram as malformações do trato genito-urinário (28%). Hemoglobina apresentou valor médio (desvio padrão) de 9,20 (1,8) g/dL, com ocorrência de anemia em 65,3% das consultas. Anemia associou-se a internação, uso de antibiótico, transfusão, uso de hidróxido de ferro endovenoso, valores baixos de creatinina, hematócrito e albumina e valores altos de ferritina, alumínio e Kt/V equilibrado (p < 0,05). A odds ratio para anemia com uso de hidróxido de ferro endovenoso foi 0,36 (95% IC 0,25-0,89), ou seja, uma chance 2,78 vezes maior de desenvolver anemia sem o uso dessa medicação. CONCLUSÕES: A anemia predominou em crianças e adolescentes com doença renal crônica, tendo como fator protetor o uso de hidróxido de ferro endovenoso. .

Exacerbation of asthma and airway infection: is the virus the villain? / Exacerbação da asma e infecção das vias aéreas: o vírus é o vilão?

OBJECTIVE: To review the available literature on the association between acute viral respiratory tract infection and the onset of asthma exacerbations, identifying the most prevalent viruses, detection methods, as well as preventive and therapeutic aspects. SOURCES: A search was conducted in PubMed, Lilacs, and SciELO databases, between the years 2002 and 2013, using the following descriptors: asthma exacerbation, virus, child, and acute respiratory infection. SUMMARY OF THE FINDINGS: A total of 42 Original Articless addressing the identification of respiratory viruses during episodes of asthma exacerbation were selected, mostly cross-sectional studies. There was a wide variation in the methodology of the assessed studies, particularly in relation to the children's age and methods of collection and viral detection. The results indicate that, in up to 92.2% of exacerbations, a viral agent was potentially the main triggering factor, and human rhinovirus was the most frequently identified factor. The pattern of viral circulation may have been responsible for the seasonality of exacerbations. The association between viral infections and allergic inflammation appears to be crucial for the clinical and functional uncontrolled asthma, but few studies have evaluated other triggering factors in association with viral infection. CONCLUSIONS: Respiratory viruses are present in the majority of asthmatic children during episodes of exacerbation. The involved physiopathological mechanisms are yet to be fully established, and the synergism between allergic inflammation and viral infection appears to determine uncontrolled disease. The role of other triggering and protective agents is yet to be clearly determined. .

OBJETIVO: Rever a literatura disponível sobre a relação entre infecção viral aguda do trato respiratório e o desencadeamento de exacerbações da asma, identificando os vírus mais prevalentes, os métodos de detecção, bem como os aspectos preventivos e terapêuticos. FONTE DOS DADOS : Foi realizada uma busca nas bases de dados PubMed, SciELO e Lilacs utilizando os descritores: asma, exacerbação, vírus, criança e infecção respiratória aguda, entre os anos de 2002 e 2013. SÍNTESE DOS DADOS: Foram selecionados 42 artigos originais que tratavam da identificação de vírus respiratórios durante episódios de exacerbação da asma, em sua maioria estudos transversais. Houve ampla variação na metodologia dos trabalhos avaliados, principalmente em relação à idade das crianças e métodos de coleta e detecção viral. Os resultados apontam que, em até 92,2% das exacerbações, um agente viral foi potencialmente o principal fator desencadeante, sendo o rinovírus humano o mais identificado. O padrão de circulação viral pode ter sido responsável pela sazonalidade das exacerbações. A associação entre infecção viral e inflamação alérgica parece ser determinante para levar ao descontrole clínico-funcional da asma, porém poucos estudos avaliaram outros fatores desencadeantes em associação com a infecção viral. CONCLUSÕES: Os vírus respiratórios estão presentes na maioria das crianças asmáticas durante os episódios de exacerbação. Os mecanismos fisiopatológicos envolvidos ainda não estão totalmente estabelecidos e o sinergismo entre a inflamação alérgica e infecção viral parece ...

Human bocavirus 1 and 3 infection in children with acute gastroenteritis in Brazil

To determine the positivity rate of human bocavirus (HBoV) 1 and 3 among children who presented with acute gastroenteritis symptoms during the period of 1994-2004 in the Central-West Region of Brazil, 762 faecal samples were tested using polymerase chain reaction (PCR) for the detection of HBoV DNA. Primers for a segment of the non-structural viral protein 1 (NS1) gene of HBoV-1 and HBoV-3 were used. Twelve HBoV-positive samples were further characterised via genomic sequencing and phylogenetic analysis. Of the samples tested, 5.8% (n = 44) were positive for HBoV-1 or HBoV-3 and co-infection was observed in 14 (31.8%) of the 44 HBoV-positive samples. Nine of the 14 samples were also positive for Rotavirus A and five were positive for Aichi virus. The genomic sequencing of the NS1 partial sequence of 12 HBoV-samples showed that 11 samples were characterised as HBoV-1 and that one was characterised as HBoV-3. The phylogenetic analysis showed that the HBoV-1 samples had a high sequence homology to others previously identified in China, Sweden and Brazil. This is the first study conducted in the Central-West Region of Brazil to detect HBoV-1 and HBoV-3 in faecal samples from children with acute gastroenteritis. Further studies are required to define the role of HBoVs as aetiological agents of gastroenteritis.