RESUMO
BACKGROUND: Ketorolac tromethamine (ie, ketorolac) is an NSAID that appears to have several mechanisms of action, including inhibition of prostaglandin synthesis, modulatory effect on opioid receptors, and nitric oxide synthesis. Ketorolac is used in the treatment of pain. There are various generic formulations of sublingual ketorolac available in Mexico. However, a literature search did not identify published data concerning the bioavailability of these formulations in the Mexican population. OBJECTIVE: The aim of this study was to compare the bioavailability of 2 sublingual formulations of ketorolac 30-mg tablets in healthy Mexican adult volunteers. METHODS: This was a randomized-sequence, open-label, single-dose, 2-period crossover (2 dosing periods x 2 treatments) study comparing the bioavailability of two 30-mg sublingual tablet formulations of ketorolac. Healthy Mexican adult (aged, 18-55 years) men and women were eligible for inclusion. Subjects were randomly assigned in a 1:1 ratio to receive a single dose of the test formulation or the reference formulation. After a 12-hour overnight fast, subjects received a single dose of the corresponding formulation. There was a 7-day washout period between administration periods. Plasma samples were obtained over a 24-hour period after administration. Plasma ketorolac concentrations were analyzed by high-performance liquid chromatography for analysis of pharmacokinetic properties, including Cmax, AUC0-24, and AUC0-infinity. Blood samples were drawn immediately after sublingual placement of the drug and at 10, 20, 30, 40, 50, 60, 75, and 90 minutes and 2, 4, 6, 8, 10, 12, and 24 hours after dosing. The formulations were considered bioequivalent if the geometric mean ratios of Cmax and AUC were within the predetermined range of 80% to 125% and if P for the 90% CIs was <0.05. Tolerability was assessed by vital sign monitoring, laboratory analysis results, and subject interviews. RESULTS: A total of 27 subjects (18 women, 9 men; mean [SD] age, 27 [9] years [range, 18-47 years]; weight, 61 [8] kg [48-79 kg]; height, 163 [8] cm [150-180 cm]) were enrolled and completed the study. Fourteen subjects received the test formulation first. No period or sequence effect was observed. The 90% CIs for the corresponding differences in natural log Cmax, AUC0-24, and AUC0-infinity were 95.94% to 114.66%, 98.34% to 105.90%, and 99.25% to 108.36%, respectively (all, (P) < 0.05), meeting the predetermined criteria for bioequivalence. Sixteen subjects experienced a total of 20 adverse events (AEs) during the study. None of the AEs were considered serious. One AE (nausea) appeared to be related to use of the reference formulation. CONCLUSIONS: In this small study in 27 healthy Mexican adult volunteers, the test formulation of a single, 30-mg sublingual tablet of ketorolac appeared to be bioequivalent to the reference formulation based on the rate and extent of absorption. Both formulations were well tolerated.
Assuntos
Anti-Inflamatórios não Esteroides/farmacocinética , Cetorolaco de Trometamina/farmacocinética , Administração Sublingual , Adolescente , Adulto , Análise de Variância , Anti-Inflamatórios não Esteroides/administração & dosagem , Anti-Inflamatórios não Esteroides/efeitos adversos , Área Sob a Curva , Disponibilidade Biológica , Cromatografia Líquida de Alta Pressão , Estudos Cross-Over , Feminino , Humanos , Cetorolaco de Trometamina/administração & dosagem , Cetorolaco de Trometamina/efeitos adversos , Masculino , México , Pessoa de Meia-Idade , Experimentação Humana não Terapêutica , Valores de Referência , Equivalência TerapêuticaRESUMO
Introduction: The COVID-19 pandemic reduced the possibilities of generating stimulating spaces for children's development, as all the systems with which a child interacts during this phase were affected. Objective: To identify the existing scientific evidence about the effects on child development in children aged less than 5 years old that were living with their parents while the social distancing measures adopted due to COVID-19 were in force. Method: An integrative review guided by the framework proposed by Whittemore and Knafl and the PRISMA statement, to consult the following databases: Medline, ScienceDirect, Scopus and SciELO, with a search performed in English using these descriptors: "child development," "growth and development," "parenting," "teleworking," "infant care," "home nursing," "social isolation," "coronavirus infections," and "COVID-19." The eligibility criteria were as follows: quantitative or qualitative studies that addressed the direct effects of the pandemic on children aged less than 5 years old; in turn, the exclusion criteria corresponded to articles with a population comprised of children with diagnosed developmental disorders or disabilities. Results: A total of 17 articles were included, whose findings were classified into the following categories: Exposure to risk stimuli, Deprivation of stimuli, and Exposure to protective stimuli. It is revealed that parental stress, absence of games and lower exposure to interactions that promote development are connected to changes in cognitive, emotional, and learning processing, in addition to exerting a negative impact on motor and language development. Conclusion: The evidence suggests that social distancing can be the main cause for the onset of delays in child development, in its motor, language, cognitive, and socioemotional areas.
Introducción: la pandemia por la covid-19 disminuyó las posibilidades de generar espacios estimulantes para el desarrollo de los niños, puesto que todos los sistemas con los que interactúa un niño en desarrollo se vieron impactados. Objetivo: identificar la evidencia científica que hay sobre los efectos en el desarrollo infantil en menores de 5 años que convivieron con sus padres y madres durante las medidas de distanciamiento social tomadas por causa de la covid-19. Método: revisión integrativa guiada por el marco propuesto por Whittemore y Knafl, y The Prisma Statement, para consultar las bases de datos: Medline, ScienceDirect, Scopus y Scielo, con una búsqueda realizada en inglés, utilizando los descriptores: "child development", "growth and development", "parenting", "teleworking", "infant care", "home nursing", "social isolation", "coronavirus infections", "COVID-19". Los criterios de elegibilidad: estudios cuantitativos o cualitativos que abordaran los efectos directos de la pandemia en niños menores de 5 años; y de exclusión: artículos con población de niñez con trastornos del desarrollo diagnosticados o discapacidad. Resultados: fueron incluidos 17 artículos, cuyos hallazgos se clasifican en las categorías: exposición a estímulos de riesgo, privación de estímulos y exposición a estímulos protectores. Se revela que el estrés parental, la ausencia de juego y una menor exposición a interacciones promotoras del desarrollo se vinculan con alteraciones en el procesamiento cognitivo, emocional y de aprendizaje, y tuvieron un impacto negativo en el desarrollo motriz y del lenguaje. Conclusión: la evidencia sugiere que el distanciamiento social puede ser la causa principal en la aparición de retrasos en el desarrollo infantil, en sus áreas: motriz, de lenguaje, cognitivo y socioemocional.
Introdução: a pandemia de COVID-19 diminuiu as possibilidades de criar espaços estimulantes para o desenvolvimento das crianças, uma vez que todos os sistemas com os quais uma criança em desenvolvimento interage foram afetados. Objetivo: identificar a evidência científica sobre os efeitos no desenvolvimento infantil das crianças com menos de 5 anos que viveram com os pais durante as medidas de distanciamento social adoptadas devido à pandemia de COVID-19. Método: revisão integrativa orientada pelo quadro proposto por Whittemore e Knafl, e The PRISMA Statement, para consultar as seguintes bases de dados: Medline, ScienceDirect, Scopus e SciELO, com uma pesquisa efetuada em inglês, utilizando os descritores: "child development", "growth and development", "parenting", "teleworking", "infant care", "home nursing", "social isolation", "coronavirus infections", "COVID-19". Critérios de elegibilidade: estudos quantitativos ou qualitativos que abordem os efeitos diretos da pandemia em crianças com menos de 5 anos de idade; e critérios de exclusão: artigos com uma população de crianças com distúrbios de desenvolvimento diagnosticados ou deficiência. Resultados: foram incluídos 17 artigos, cujos resultados se enquadram nas categorias: exposição a estímulos de risco, privação de estímulos e exposição a estímulos protetores. Verificou-se que o stress parental, a ausência de brincadeiras e a menor exposição a interações de apoio ao desenvolvimento estavam associados a alterações no processamento cognitivo, emocional e de aprendizagem, e tinham um impacto negativo no desenvolvimento motor e da linguagem. Conclusão: os dados sugerem que o distanciamento social pode ser a principal causa de atrasos no desenvolvimento da criança nas áreas motora, linguística, cognitiva e socioemocional.
Assuntos
Enfermagem Pediátrica , Desenvolvimento Infantil , Cuidadores , Meio Ambiente , Família , COVID-19RESUMO
BACKGROUND: Bright constant light levels in the NICU may have negative effects on the growth and development of preterm infants OBJECTIVE: The aim of this study is to evaluate the benefits of an alternating light/dark cycle in the NICU on weight gain and early discharge from the therapy in premature infants. PATIENTS AND METHODS: A randomized interventional study was designed comparing infants in the NICU of Hospital Juarez de México, exposed from birth either to an LD environment (LD, n=19) or to the traditional continuous light (LL, n=19). The LD condition was achieved by placing individual removable helmets over the infant's heads. Body weight gain was analyzed, as the main indicator of stability and the main criteria for discharge in preterm infants born at 31.73±0.31week gestational age. RESULTS: Infants maintained in an LD cycle gained weight faster than infants in LL and therefore attained a shorter hospital stay, (34.37±3.12 vs 51.11±5.29days; P>0.01). Also, LD infants exhibited improved oxygen saturation and developed a daily melatonin rhythm. CONCLUSIONS: These findings provide a convenient alternative for establishing an LD environment for preterm healthy newborns in the NICU and confirm the beneficial effects of an alternating LD cycle for growth and weight gain and for earlier discharge time. Here we provide an easy and practical alternative to implement light/dark conditions in the NICU.