No abstract

Ketorolac was administered to 15 healthy volunteers in a phase 1, single-dose, crossover, randomized study. Subjects received open-label randomized 15- and 30-mg intramuscular (i.m.) ketorolac and blinded randomized 15- and 30-mg intranasal (i.n.) ketorolac. The i.n. ketorolac was well tolerated; the only nasal symptoms were some instances of mild irritation. The i.n. ketorolac was rapidly and well absorbed (median tmax, 0.50-0.75 hours), and the half-life was approximately 5 to 6 hours, values that were similar to those following i.m. administration. Relative bioavailability of i.n. compared to i.m. administration at the same doses was approximately 67% to 75%. Dose proportionality was noted between the 15- and 30-mg i.n. and i.m. dose levels. Thus, i.n. ketorolac offers a therapeutic alternative to i.m. administration and may provide benefits in the clinical setting.

BACKGROUND: Our primary aim was to evaluate the effects of 2 family-based obesity management interventions compared with a control group on BMI in low-income adolescents with overweight or obesity. METHODS:In this randomized clinical trial, 360 urban-residing youth and a parent were randomly assigned to 1 of 2 behaviorally distinct family interventions or an education-only control group. Eligible children were entering the sixth grade with a BMI $85th percentile. Interventions were 3 years in length; data were collected annually for 3 years. Effects of the interventions on BMI slope (primary outcome) over 3 years and a set of secondary outcomes were assessed.RESULTS: Participants were primarily African American (77%), had a family income of ,25 000 per year, and obese at enrollment (68%). BMI increased over time in all study groups, with group increases ranging from 0.95 to 1.08. In an intent-to-treat analysis, no significant differences were found in adjusted BMI slopes between either of the family-based interventions and the control group (P = .35). No differences were found between the experimental and control groups on secondary outcomes of diet, physical activity, sleep, perceived stress, or cardiometabolic factors. No evidence of effect modification of the study arms by sex, race and/or ethnicity, household income, baseline levels of child and parent obesity, or exposure to a school fitness program were found. CONCLUSIONS:In this low-income, adolescent population, neither of the family-based interventions improved BMI or health-related secondary outcomes. Future interventions should more fully address poverty and other social issues contributing to childhood obesity.

An achiral/chiral high-performance liquid chromatographic system for the analysis of total warfarin together with the (R)- and (S)-enantiomers in clinical samples has been developed. The achiral analysis is achieved using a C8 column, which is coupled to a chiral stationary phase, alpha 1-acid glycoprotein (AGP), thereby allowing for analysis of warfarin isomers without interfering serum peaks. A 0.015 M phosphate buffer mobile phase with 15% v/v propan-2-ol (pH 7.0) was used on the C8/AGP system. UV analysis at 308 nm was used for quantitation of total warfarin on the C8 column and fluorescence (excitation 300 nm, emission 390 nm) detection was employed for isomer quantitation on the AGP. Retention time of total warfarin on the C8 column was 5.95 min, while that of the (S)- and (R)-warfarin on the AGP column was 10.38 and 12.69 min, respectively. Peak resolution of the warfarin isomers was 1.64. All serum samples were subjected to solid-phase extraction. Data from two patients in a single dose study indicate that a two-compartmental model could represent the warfarin concentration-time data with enterohepatic circulation. In some patients studied during steady state therapy, concentrations of (S)-warfarin were greater than (R)-warfarin indicating that the clearance of the former is slower in these patients.

Background: The Healthy Eating Index (HEI-2010) is a measure of diet quality that examines conformance with the Dietary Guidelines for Americans. The objectives of this study were to estimate baseline diet quality of predominantly low-income minority children using the HEI-2010 and to identify the most important HEI components to target for dietary intervention. Methods: Two or three baseline 24 h dietary recalls were collected in-person or over telephone between May 2012 and June 2014 from 1,745 children and adolescents from four randomized clinical trials in the Childhood Obesity Prevention and Treatment Research (COPTR) Consortium. Nine adequacy and three moderation food components were calculated and averaged to determine overall HEI scores. The overall HEI-2010 scores were categorized as ≥81, 51-80, or ≤ 50 based on the HEI-2005 classification. For each study, mean overall and component HEI scores were estimated using linear regression models. Results: Mean (95% CI) overall HEI scores ranged from 47.9 (46.8, 49.0) to 64.5 (63.6, 65.4). Only 0.3 to 8.1% of children and adolescents had HEI-2010 score ≥ 81. The average component score for green and beans was less than 30% of maximum score for all trials. In contrast, the average component score for protein, dairy (except for IMPACT), and empty calories (except forIMPACT) was more than 80% of maximum score. Conclusions: Based on HEI-2010 scores, few children and adolescents consumed high quality diets. Dietary interventions for children and adolescents should focus on improving intakes of green vegetables and beans.