Pediatrics
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Randomized Controlled Trial Multicenter Study Comparative Study Clinical Trial
A comparison of once-daily extended-release methylphenidate formulations in children with attention-deficit/hyperactivity disorder in the laboratory school (the Comacs Study).
The objective of this study was to evaluate differences in the pharmacodynamic (PD) profile of 2 second-generation extended-release (ER) formulations of methylphenidate (MPH): Metadate CD (MCD; methylphenidate HCl, US Pharmacopeia) extended-release capsules, CII, and Concerta (CON; methylphenidate HCl) extended-release tablets, CII. Little empirical information exists to help the clinician compare the PD effects of the available ER formulations on attention and behavior. Previous studies have shown that the near-equal doses of MCD and CON provide equivalent, total exposure to MPH as measured by area under the plasma concentration time curve, yet their pharmacokinetic (PK) plasma concentration versus time profiles are different. We previously offered a theoretical PK/PD account of the similarities and differences among available ER formulations based on the hypothesis that all formulations produce effects related to MPH delivered by 2 processes: 1) an initial bolus dose of immediate-release (IR) MPH that is expected to achieve peak plasma concentration in the early morning and have rapid onset of efficacy within 2 hours of dosing, which for the MCD capsule is delivered by 30% of the total daily dose as uncoated beads and for the CON tablet is delivered by an overcoat of 22% of the total daily dose; and 2) an extended, controlled delivery of ER MPH that is expected to achieve peak plasma concentrations in the afternoon to maintain efficacy for a programmed period of time after the peak of the initial bolus, which for the MCD capsule is delivered by polymer-coated beads and for the CON tablet by an osmotic-release oral system. According to this PK/PD model, clinical superiority is expected at any point in time for the formulation with the highest MPH plasma concentration. ⋯ Once-daily doses of MCD and CON produced statistically significantly different PD effects on surrogate measures of behavior and performance among children with attention-deficit/hyperactivity disorder in the laboratory school setting. As predicted by the PK/PD model, superiority at any point in time was achieved by the formulation with the highest expected plasma MPH concentration.
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Randomized Controlled Trial Multicenter Study Clinical Trial
A randomized trial of early versus standard inhaled nitric oxide therapy in term and near-term newborn infants with hypoxic respiratory failure.
Inhaled nitric oxide (iNO) reduces the use of extracorporeal membrane oxygenation (ECMO)/incidence of death in term and near-term neonates with severe hypoxic respiratory failure. We conducted a randomized, double masked, multicenter trial to determine whether administration of iNO earlier in respiratory failure results in additional reduction in the incidence of these outcomes. ⋯ iNO improves oxygenation but does not reduce the incidence of ECMO/mortality when initiated at an OI of 15 to 25 compared with initiation at >25 in term and near-term neonates with respiratory failure.
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Randomized Controlled Trial Comparative Study Clinical Trial
A comparison of buffered lidocaine versus ELA-Max before peripheral intravenous catheter insertions in children.
Peripheral intravenous catheter (PIV) insertion is a common, painful experience for many children in the pediatric emergency department. Although local anesthetics such as injected buffered lidocaine have been shown to be effective at reducing pain and anxiety associated with PIV insertion, they are not routinely used. ELA-Max, a topical local anesthetic, has the advantage of needle-free administration but has not been compared with buffered lidocaine for PIV insertion. ⋯ ELA-Max provided similar pain and anxiety reduction during PIV insertion in children compared with injected buffered lidocaine. Technical difficulty and satisfaction by nurses inserting the PIV also were similar.
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Comparative Study
Effectiveness and safety of tissue plasminogen activator in the management of complicated parapneumonic effusions.
The management of parapneumonic effusions in children is controversial. The objective of this study was to evaluate the effectiveness and safety of intrapleural tissue plasminogen activator (tPA) in children who require tube thoracostomy for drainage of a complicated parapneumonic effusion. ⋯ Early administration of intrapleural tPA seems to be a safe and potentially effective treatment in children with complicated parapneumonic effusions. Randomized controlled trial evidence is needed to confirm this finding.
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This study examines patterns of specialist use among children and adolescents by presence of a chronic condition or disability, insurance, and sociodemographic characteristics. ⋯ The results showed that, overall, 13% of children used a specialist in a year. Among the insured, a slightly greater percentage of children used such care (15%). These numbers were slightly lower than the 18% to 28% of pediatric patients referred per year in 5 US health plans, although the sources of data and definitions of specialist use differ. Our results showed that 26% of children with a chronic condition or disability who were insured by Medicaid use a specialist. Although the data are not directly comparable, this is within the range of previous findings showing annual rates by condition of use between 24% and 59%. These findings are consistent also with greater use of many different types of health care by children with special health care needs. Medicaid-utilization rates presented here were similar also to the rates found among privately insured children and children with "other" insurance. In our earlier work examining use of specialists by children insured by Medicaid, we speculated that Medicaid-insured children might face particular difficulty with access (eg, due to transportation or language barriers). The findings presented here suggest that children insured by Medicaid had no different use of specialists than other insured children. We do not know, however, whether similar rates are appropriate. As predicted, sociodemographic differences were pronounced and followed patterns typically found for use of health services. Lower rates of specialist use by non-Hispanic blacks and Hispanics remains even, controlling for chronic condition/disability, status, insurance, and socioeconomic status. This is an important issue that not only needs to be addressed in using specialist care but also in many areas in health care. It is the near poor who seem to have difficulty accessing care (as is evidenced by lower use of specialists). In a study of access to care, similar results were found, with those between 125% and 200% of the federal poverty level being less likely to have a usual source of care. This is roughly the population targeted by the State Children's Health Insurance Programs. These findings cannot determine whether rates of use are too high or too low. Additional work on outcomes for children who do and do not use specialist care would further inform the work presented here. Extending that work to examine patterns of care including but not limited to specialists and generalists would be even better.