Intraoperative clonidine to prevent postoperative emergence delirium following sevoflurane anesthesia in pediatric patients: a randomized clinical trial.

INTRODUCTION AND OBJECTIVE: Emergence Delirium (ED), particularly in children, is characterized by mental confusion, irritability, disorientation, and inconsolable crying. ED prolongs the time required in the Post-Anesthesia Care Unit (PACU) and increases concern and anxiety in parents. The present study aimed to determine the effectiveness and safety of low-dose clonidine in preventing ED in children receiving sevoflurane anesthesia for tonsillectomy/adenotonsillectomy. METHODS: A randomized, double-blind clinical trial was conducted between November 2013 and January 2014. Sixty-two children aged 2-12 years, scheduled to undergo tonsillectomy/adenotonsillectomy, and classified as American Society of Anesthesiologists (ASA) physical status I/II were included, with 29 being randomized to receive 1 µg.kg-1 clonidine intravenously, and 33 allocated to a control group that received no clonidine. Anesthesia was induced and maintained with sevoflurane. Children with altered state of consciousness, neurological deficit, history of allergy to dipyrone, or receiving other drugs such as preanesthetic agents were excluded from the study. The primary outcome was the presence of ED in the initial 20 minutes in the PACU according to the Pediatric Anesthesia Emergence Delirium (PAED) scale. The Chi-Square test and Fisher's two-tailed exact test were used for statistical analysis, as applicable. Significance level was set at 5%, and Risk Ratios (RR) and their 95% Confidence Intervals (95% CI) were calculated. RESULTS: The frequency of ED was significantly decreased in the group of children who received clonidine (17.2% vs. 57.6%; RR = 0.30; 95% CI 0.13-0.70; p =  0.001). There was no difference between groups with respect to the frequency of postoperative self-harm (falls and bruises), dislodged catheters, and for most of the other adverse events evaluated. CONCLUSIONS: The use of 1 µg.kg-1 intravenous clonidine during anesthesia induction can effectively reduce the incidence of ED in children undergoing elective tonsillectomy/adenotonsillectomy under general inhalation anesthesia with sevoflurane. CLINICALTRIALS. GOV IDENTIFIER: NCT02181543.

Abordagem das reações de hipersensibilidade perioperatória: Orientações da Sociedade Brasileira de Anestesiologia e da Associação Brasileira de Alergia e Imunologia - Parte II: etiologia e diagnóstico / Approach to perioperative hypersensitivity reactions: Guidelines from the Brazilian Society of Anesthesiology and the Brazilian Association of Allergy and Immunology - Part II: etiology and diagnosis

A anafilaxia perioperatória é manifestação importante no contexto de eventos adversos relacionados à cirurgia. Embora frequentemente relacionada à indução anestésica, pode ocorrer por outros agentes administrados por outras vias. A anafilaxia pode se apresentar como colapso cardiovascular, obstrução da via aérea e/ou insuficiência respiratória com ou sem manifestação cutânea, com consequências fatais em muito casos. Apesar de considerada inevitável em alguns casos, a sua incidência poderia (e deveria) ser reduzida através da busca por fármacos mais seguros. A avaliação abrangente de um episódio é um dos elementos primordiais para tornar a exposição subsequente mais segura, com orientações derivadas dessa investigação. Entretanto, representa um desafio estatístico por ser reação rara, randômica e muitas vezes independente de exposições sucessivas dos pacientes a procedimentos de baixo risco. Neste documento são revisados os mecanismos fisiopatológicos, agentes desencadeantes (adultos e crianças), assim como a abordagem diagnóstica durante a crise e após o episódio. Uma avaliação abrangente, a identificação das medicações, antissépticos e outras substâncias usadas em cada região, registros detalhados e nomenclatura padronizada são pontos fundamentais para a obtenção de dados epidemiológicos mais fidedignos sobre a anafilaxia perioperatória.

Perioperative anaphylaxis is an important manifestation in the context of surgery-related adverse events. Although often related to anesthetic induction, it may be caused by other agents administered by other routes. Anaphylaxis may manifest as cardiovascular collapse, airway obstruction and/or respiratory failure with or without skin manifestation, resulting often in death. Although this reaction is considered inevitable in some cases, its incidence could (and should) be reduced by the search for safer drugs. Comprehensive assessment of an allergic reaction is a key element to make subsequent exposure safer, with guidance derived from this investigation. However, surveillance of perioperative anaphylaxis represents a statistical challenge because this is a rare, random reaction and often independent of successive patient exposures to low-risk procedures. This paper reviews pathophysiological mechanisms, triggering agents (adults and children), as well as therapeutic and diagnostic approach during and after an allergic reaction. Comprehensive assessment, identification of medications/antiseptics used in each region and detailed records with standardized terminology are key points for obtaining more reliable epidemiological data on perioperative anaphylaxis.

A Multistage Formulation Based on Full-Length CSP and AMA-1 Ectodomain of Plasmodium vivax Induces High Antibody Titers and T-cells and Partially Protects Mice Challenged with a Transgenic Plasmodium berghei Parasite.

Infections with Plasmodium vivax are predominant in the Americas, representing 75% of malaria cases. Previously perceived as benign, malaria vivax is, in fact, a highly debilitating and economically important disease. Considering the high complexity of the malaria parasite life cycle, it has been hypothesized that an effective vaccine formulation against Plasmodium should contain multiple antigens expressed in different parasite stages. Based on that, we analyzed a recombinant P. vivax vaccine formulation mixing the apical membrane antigen 1 ectodomain (PvAMA-1) and a full-length circumsporozoite protein (PvCSP-AllFL) previously studied by our group, which elicits a potent antibody response in mice. Genetically distinct strains of mice (C57BL/6 and BALB/c) were immunized with the proteins, alone or in combination, in the presence of poly(I:C) adjuvant, a TLR3 agonist. In C57BL/6, high-antibody titers were induced against PvAMA-1 and the three PvCSP variants (VK210, VK247, and P. vivax-like). Meanwhile, mixing PvAMA-1 with PvCSP-AllFL had no impact on total IgG antibody titers, which were long-lasting. Moreover, antibodies from immunized mice recognized VK210 sporozoites and blood-stage parasites by immunofluorescence assay. However, in the BALB/c model, the antibody response against PvCSP-AllFL was relatively low. PvAMA-1-specific CD3+CD4+ and CD3+CD8+ T-cell responses were observed in C57BL/6 mice, and the cellular response was impaired by PvCSP-AllFL combination. More relevant, the multistage vaccine formulation provided partial protection in mice challenged with a transgenic Plasmodium berghei sporozoite expressing the homologous PvCSP protein.

Atualização sobre reações de hipersensibilidade perioperatória: Documento conjunto da Sociedade Brasileira de Anestesiologia e Associação Brasileira de Alergia e Imunologia ­ Parte II: etiologia e diagnóstico / Update on perioperative hypersensitivity reactions: Joint document from the Brazilian Society of Anesthesiology and Brazilian Association of Allergy and Immunology ­ Part II: Etiology and diagnosis

A anafilaxia perioperatória é manifestação importante no contexto de eventos adversos relacionados à cirurgia. Embora frequentemente relacionada à indução anestésica, pode ocorrer por outros agentes administrados por outras vias. A anafilaxia pode se apresentar como colapso cardiovascular, obstrução da via aérea e/ou insuficiência respiratória com ou sem manifestação cutânea, com consequências fatais em muito casos. Apesar de considerada inevitável em alguns casos, a sua incidência poderia (e deveria) ser reduzida através da busca por fármacos mais seguros. A avaliação abrangente de um episódio é um dos elementos primordiais para tornar a exposição subsequente mais segura, com orientações derivadas dessa investigação. Entretanto, representa um desafio estatístico por ser reação rara, randômica e muitas vezes independente de exposições sucessivas dos pacientes a procedimentos de baixo risco. Neste documento são revisados os mecanismos fisiopatológicos, agentes desencadeantes (adultos e crianças), assim como a abordagem diagnóstica durante a crise e após o episódio. Uma avaliação abrangente, a identificação das medicações, antissépticos e outras substâncias usadas em cada região, registros detalhados e nomenclatura padronizada são pontos fundamentais para a obtenção de dados epidemiológicos mais fidedignos sobre a anafilaxia perioperatória.

Perioperative anaphylaxis is an important manifestation in the context of surgery-related adverse events. Although often related to anesthetic induction, it may be caused by other agents administered by other routes. Anaphylaxis may manifest as cardiovascular collapse, airway obstruction and/or respiratory failure with or without skin manifestation, resulting often in death. Although this reaction is considered inevitable in some cases, its incidence could (and should) be reduced by the search for safer drugs. Comprehensive assessment of an allergic reaction is a key element to make subsequent exposure safer, with guidance derived from this investigation. However, surveillance of perioperative anaphylaxis represents a statistical challenge because this is a rare, random reaction and often independent of successive patient exposures to low-risk procedures. This paper reviews pathophysiological mechanisms, triggering agents (adults and children), as well as therapeutic and diagnostic approach during and after an allergic reaction. Comprehensive assessment, identification of medications/antiseptics used in each region and detailed records with standardized terminology are key points for obtaining more reliable epidemiological data on perioperative anaphylaxis.

Brazilian adaptation and validation of the Empowerment of Parents in the Intensive Care-Neonatology (EMPATHIC-N) questionnaire / Adaptação brasileira e validação do questionário Empowerment of Parents in the Intensive Care-Neonatology (EMPATHIC-N)

Abstract Objectives: Considering the lack of questionnaires that propose to evaluate parental satisfaction with the Neonatal Intensive Care Unit (NICU) in Brazil, this study aimed to carry out the translation of the EMPATHIC-N questionnaire into Brazilian Portuguese, the cross-cultural adaptation and validation of its contents. Method: The translation and cultural adaptation of the questionnaire was carried out according to the protocol established by the Translation and Cross-Cultural Adaptation Group of the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) in 2005. The validation of the content was carried out by a panel of experts, who evaluated each item from "very irrelevant" to "very relevant". Items with a mean Likert scale value <3.5 were excluded. Cronbach's alpha of the domains was calculated. Results: The questionnaire was submitted to two pilot tests with mothers of newborns admitted to the NICU of the study, after which some terms were modified to achieve global understanding. Cronbach's alpha remained above 0.7 in all items. Conclusion: The tool resulting from the translation, cultural adaptation, and validation of the EMPATHIC-N questionnaire showed to be adequate to assess satisfaction of parents of newborns admitted to the NICU in Brazil.

Resumo Objetivos: Considerando a ausência de questionários que se proponham a avaliar satisfação de pais em Unidade de Cuidados Intensivos Neonatal (UCIN) no Brasil, o presente estudo teve o objetivo de fazer a tradução do questionário Empowerment of Parents in the Intensive Care- Neonatology (Empathic-N) para o português brasileiro, adaptação transcultural e validação de seu conteúdo. Método: Foi feita tradução e adaptação transcultural do questionário, segundo protocolo estabelecido pelo Grupo da Tradução e Adaptação Transcultural da Sociedade Internacional para Pesquisas Farmacoeconômicas (Ispor) em 2005. A validação do conteúdo foi feita por um comitê de especialistas, que avaliaram cada item de “muito irrelevante” a “muito relevante”. Foram excluídos os itens com média da Escala Likert menor do que 3,5. Foi calculado alfa de Cronbach dos domínios. Resultados: Na tradução foi invertida a ordem de algumas frases de acordo com a sintaxe do português brasileiro e alterado o tempo verbal para terceira pessoa do pretérito imperfeito. A maior parte das afirmativas manteve o sentido com a retradução, as diferenças foram atribuídas ao uso de sinônimos pelos dois tradutores. Foi submetido a dois testes-piloto com mães de recém-nascidos internados na UCIN do estudo, modificaram-se alguns termos até se atingir compreensão global. O alfa de Cronbach permaneceu acima de 0,7 em todos os itens. Conclusão: O instrumento resultante da tradução, adaptação transcultural e validação do Empathic-N mostra-se adequado para avaliar satisfação dos pais de recém-nascidos internados em UCIN no Brasil.

Smartphone-based behavioural intervention alleviates children's anxiety during anaesthesia induction: A randomised controlled trial.

BACKGROUND: Preoperative anxiety negatively influences children's anaesthetic and surgical experience, and results in postoperative complications, such as emergence delirium and behavioural changes. Nonpharmacological management using alternative therapies that alleviate psychological stress can be as important as pharmacological ones in reducing children's anxiety. Nevertheless, their validity as an effective anxiety-reducing strategy in children remains controversial. OBJECTIVE(S): To verify whether nonpharmacological strategies, that is, leaflet and distraction with smartphone application presented to parents/guardians and children, respectively, were effective in preventing children's anxiety during anaesthesia induction. DESIGN: Randomised clinical trial. SETTING: A tertiary care teaching hospital. PATIENTS: In total, 84 children (aged 4 to 8 years; American Society of Anesthesiologists I and II) undergoing minor-to-moderate elective surgical procedures and their parents/guardians. INTERVENTIONS: Children were randomised into four groups: control group, in which the parent/guardian was verbally informed about the anaesthetic procedure; the informed group, in which the parent/guardian was also provided with an information leaflet about the anaesthetic procedure; the smartphone group, in which the parent/guardian was verbally informed and the child received a smartphone application to play with while in the holding area before entering the operating room and the smartphone and informed group, in which the parent/guardian also received an information leaflet and the child, a smartphone application to play with while in the holding area before entering the operating room. MAIN OUTCOME MEASURES: Children's anxiety at two time points: in the holding area of the surgical centre and in the operating room during induction of anaesthesia by facemask. RESULTS: Median (IQR) anxiety levels were greater at time point operating room for children in the control group (55.0; range: 30.0 to 68.4) than in the other groups: informed group, 28.4 (23.4 to 45.0); smartphone group, 23.4 (23.4 to 30.0); smartphone and informed group, 23.4 (23.4 to 25.9). CONCLUSION: The behavioural distraction strategies using smartphones were effective in preventing an increase in children's anxiety during anaesthesia induction. TRIAL REGISTRATION: clinicaltrials.gov identifier: NCT02246062.

Brazilian adaptation and validation of the Empowerment of Parents in the Intensive Care-Neonatology (EMPATHIC-N) questionnaire.

OBJECTIVES: Considering the lack of questionnaires that propose to evaluate parental satisfaction with the Neonatal Intensive Care Unit (NICU) in Brazil, this study aimed to carry out the translation of the EMPATHIC-N questionnaire into Brazilian Portuguese, the cross-cultural adaptation and validation of its contents. METHOD: The translation and cultural adaptation of the questionnaire was carried out according to the protocol established by the Translation and Cross-Cultural Adaptation Group of the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) in 2005. The validation of the content was carried out by a panel of experts, who evaluated each item from "very irrelevant" to "very relevant". Items with a mean Likert scale value <3.5 were excluded. Cronbach's alpha of the domains was calculated. RESULTS: The questionnaire was submitted to two pilot tests with mothers of newborns admitted to the NICU of the study, after which some terms were modified to achieve global understanding. Cronbach's alpha remained above 0.7 in all items. CONCLUSION: The tool resulting from the translation, cultural adaptation, and validation of the EMPATHIC-N questionnaire showed to be adequate to assess satisfaction of parents of newborns admitted to the NICU in Brazil.

The relationship between dual-task and cognitive performance among elderly participants who exercise regularly.

BACKGROUND: The dual-task performance is associated with the functionality of the elderly and it becomes more complex with age. OBJECTIVE: To investigate the relationship between the Timed Up and Go dual task (TUG-DT) and cognitive tests among elderly participants who exercise regularly. METHOD: This study examined 98 non-institutionalized people over 60 years old who exercised regularly. Participants were assessed using the TUG-DT (i.e. doing the TUG while listing the days of the week in reverse order), the Montreal Cognitive Assessment (MoCA), the Clock Drawing Test (CDT), and the Mini Mental State Examination (MMSE). The motor (i.e. time and number of steps) and cognitive (i.e. number of correct words) data were collected from TUG-DT. We used a significance level of α=0.05 and SPSS 17.0 for all data analyses. RESULTS: This current elderly sample featured a predominance of women (69.4%) who were highly educated (median=10 years of education) compared to Brazilian population and mostly non-fallers (86.7%). The volunteers showed a good performance on the TUG-DT and the other cognitive tests, except the MoCA, with scores below the cutoff of 26 points. Significant and weak correlations were observed between the TUG-DT (time) and the visuo-spatial/executive domain of the MoCA and the MMSE. The cognitive component of the TUG-DT showed strong correlations between the total MoCA performance score and its visuo-spatial/executive domain. CONCLUSIONS: The use of the TUG-DT to assess cognition is promising; however, the use of more challenging cognitive tasks should be considered when the study population has a high level of education.

The relationship between dual-task and cognitive performance among elderly participants who exercise regularly

BACKGROUND: The dual-task performance is associated with the functionality of the elderly and it becomes more complex with age. OBJECTIVE: To investigate the relationship between the Timed Up and Go dual task (TUG-DT) and cognitive tests among elderly participants who exercise regularly. METHOD: This study examined 98 non-institutionalized people over 60 years old who exercised regularly. Participants were assessed using the TUG-DT (i.e. doing the TUG while listing the days of the week in reverse order), the Montreal Cognitive Assessment (MoCA), the Clock Drawing Test (CDT), and the Mini Mental State Examination (MMSE). The motor (i.e. time and number of steps) and cognitive (i.e. number of correct words) data were collected from TUG-DT . We used a significance level of α=0.05 and SPSS 17.0 for all data analyses. RESULTS: This current elderly sample featured a predominance of women (69.4%) who were highly educated (median=10 years of education) compared to Brazilian population and mostly non-fallers (86.7%). The volunteers showed a good performance on the TUG-DT and the other cognitive tests, except the MoCA, with scores below the cutoff of 26 points. Significant and weak correlations were observed between the TUG-DT (time) and the visuo-spatial/executive domain of the MoCA and the MMSE. The cognitive component of the TUG-DT showed strong correlations between the total MoCA performance score and its visuo-spatial/executive domain. CONCLUSIONS: The use of the TUG-DT to assess cognition is promising; however, the use of more challenging cognitive tasks should be considered when the study population has a high level of education. .

Lumbar punctures in thrombocytopenic children with cancer.

INTRODUCTION: Lumbar punctures (LP) in patients presenting thrombocytopenia are linked to the possibility of bleeding and spinal hematomas. The minimum platelet count required for the safe performance of spinal procedures is still under discussion. Children with some oncology diseases require routinely lumbar punctures; such patients often present thrombocytopenia, making this group an ideal population to study the association between lumbar puncture in thrombocytopenic patients and complications. OBJECTIVES: To determine the platelet count of oncology children undergone lumbar punctures and the occurrence of spinal hematomas. METHOD: Observational longitudinal study. It included a retrospective analysis of electronic medical records of oncology patients submitted to LP for intrathecal chemotherapy between January 2004 and October 2011, carried out at the 'Instituto de Medicina Integral Prof. Fernando Figueira (IMIP)', Recife, Brazil. RESULTS: We evaluated 9088 lumbar punctures performed in 440 patients. The platelet count distribution before lumbar punctures was as follows: 25 punctures had zero to 10,000 platelets per mm(3), 67 punctures had between 10,000 and 20,000 platelets per mm(3), 88 had between 20,000 and 30,000 platelets per mm(3), 92 punctures had between 30,000 and 40,000 platelets per mm(3), 107 punctures had between 40,000 and 50,000 platelets per mm(3), and 729 punctures had between 50,000 and 100,000 platelets per mm(3). In this series, the incidence of bloody tap was 16.9% (1112 lumbar punctures of 6552 had more than ten erythrocytes). No complications were observed. CONCLUSIONS: Even in thrombocytopenic patient, an epidural hematoma would be a relatively rare complication following lumbar puncture. Despite the large number of punctures performed on patients with platelet counts below 100,000 mm(-3) (n = 1108), further studies are necessary in order to determine a lower safe platelet count threshold for the performance of lumbar punctures in healthy patients undergoing neuraxial anesthesia.

Fatores associados aos óbitos neonatais e pós-neonatais em Moçambique / Factores asociados a los óbitos neonatales e postneonatales en Mozambique / Factors related to neonatal and post-neonatal mortality in Mozambique

Este trabalho procura descrever e analisar os fatores associados aos óbitos neonatais e pós-neonatais em Moçambique, entre 1998 e 2003, com base nas informações da Demographic and Health Survey (DHS). Foram utilizadas as distribuições de frequência das características selecionadas, segundo os segmentos neonatal e pós-neonatal. Empregou-se, também, a regressão logística de resposta binária, múltipla, com entrada sequencial das variáveis, de forma a verificar a mudança na magnitude e a significância dos coeficientes. Entre alguns resultados obtidos, destacam-se os fatores que se relacionaram de forma inequívoca ao aumento da chance de mortalidade neonatal e pós-neonatal: ser o primeiro filho; tamanho pequeno ao nascimento; e residência na região Norte. A idade da mãe entre 30 e 34 anos revelou-se elemento protetor do óbito infantil nos dois segmentos, enquanto a faixa de 10 a 19 anos apresentou-se como fator de aumento da chance do óbito pós-neonatal. O tamanho grande ao nascimento mostrou-se protetor no caso do segmento pós-neonatal, assim como a residência na região Sul. Finalmente, o parto domiciliar revelou-se deletério ao óbito pósneonatal.

Este trabajo procura describir y analizar los factores asociados a los óbitos neonatales y postneonatales en Mozambique, entre 1998 y 2003, en base a la información de Demographic and Health Survey (DHS). Se utilizaron las distribuciones de frecuencia de las características seleccionadas, conforme el segmento neonatal y postneonatal. Se empleó, también, la regresión logística de respuesta binaria, múltiple, con entrada secuencial de las variables, de forma que se pudiese verificar el cambio en la magnitud y la relevancia de los coeficientes. Entre algunos de los resultados obtenidos, se destacan los factores que se relacionaron de forma inequívoca con el aumento de la probabilidad de mortalidad neonatal y postneonatal: ser el primer hijo; tamaño pequeño al nacer; y residir en la región Norte. La edad de la madre entre 30 y 34 años se reveló como un elemento protector del óbito infantil en los dos segmentos, mientras que para la franja de los 10 a 19 años se presentó como un factor de aumento de la probabilidad de óbito postneonatal. El tamaño grande en el nacimiento se mostró como protector en el caso del segmento postneonatal, así como residir en la región Sur. Finalmente, el parto en el domicilio se reveló deletéreo para el óbito postneonatal.

This article describes and analyzes factors related to neonatal and post-neonatal deaths in Mozambique between 1998 and 2003, based on information from the Demographic and Health Survey (DHS). Distributions in the frequency of the selected characteristics for the neonatal and post-neonatal segments were studied. Multiple logistic regression with binary responses, and sequential entrance of the variables were used in order to verify changes in the levels and significance of the coefficients. The most important findings are related to the unequivocal associated factors in the odds of neonatal and post-neonatal deaths, such as being the first child, small size at birth, and residence in the northern region of the country. Mothers' being between the ages of 30 and 34 was seen as a protective element against infant mortality in both segments. In contrast, mothers being in the age group between 10 and 19 was shown to be a factor that increased odds of post-neonatal death. Size at birth was also seen as a factor of protection for the post-neonatal segment, as was residence in the southern region of Mozambique. Finally, the death rate was lower among post-neonatal newborns who were given birth at home.