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Two blinded single-dose studies randomized children 6 months to 11 years old with fever to receive ibuprofen (IBU) pediatric suspension 7.5 mg/kg or acetaminophen (APAP) suspension 10 to 15 mg/kg. The primary efficacy parameter was time-weighted sum of temperature differences (TWSTD) from baseline through 8 hours for each study. Secondary end points included TWSTD from baseline through 6 hours, time to onset and duration of temperature control, and proportion with temperature control. Studies were pooled for post hoc analyses of efficacy and adverse event end points. The primary efficacy parameter significantly favored IBU over APAP in study 1 and the pooled analysis (both P < .001), but was not significant in study 2. Onset of temperature control significantly favored IBU in study 2 (P = .007). Individual and pooled secondary efficacy outcomes supported significant advantages (P < .05) of IBU over APAP. IBU pediatric suspension provided greater temperature reduction versus acetaminophen in febrile children, with a comparable safety profile. [ABSTRACT FROM AUTHOR]

Background. Benefits associated with probiotic administration to children seeking emergency department care with diarrheal disease are unknown. Methods. In this 3-site, double-blind, placebo-controlled study, children aged 4 to 48 months with gastroenteritis were randomized to receive 5 days of placebo, low-dose (4 × 109 colony forming units per day), or high-dose (8 × 109 colony forming units per day) probiotic (Lactobacillus helveticus and Lactobacillus rhamnosus) in a 2:1:1 ratio. The primary outcome was day care absenteeism. Results. The proportion of children missing a day of day care was 63% (39/62) and 61% (37/61) in the placebo and probiotic arms, respectively (95%CI −14.6% to 18.9%). The proportions experiencing unscheduled health care provider visits and intravenous fluid rehydration were 24% (15/62), 7% (4/62), and 30% (18/61), 5% (3/61) in the placebo and probiotic study arms, respectively (P = .52 and P = .65). None of the results differed based on probiotic dose. Conclusions. The probiotic evaluated did not reduce absenteeism. Since power was suboptimal, further evaluation is required. [ABSTRACT FROM AUTHOR]

Background. Clinician-led tactile stimulation (rubbing the skin adjacent to the injection site or applying pressure) has been demonstrated to reduce pain in children and adults undergoing vaccination. Objective. To evaluate the analgesic effectiveness of clinician-led tactile stimulation in infants undergoing vaccination. Methods. This was a partially blinded randomized controlled trial that included infants undergoing vaccination in a private clinic in Toronto. Infants were randomly allocated to tactile stimulation or no tactile stimulation immediately prior to, during, and after vaccination. The primary outcome was infant pain, assessed using a validated observational measure, the Modified Behavioral Pain Scale (MBPS; range = 0-10). Results. Altogether, 121 infants participated (n = 62 tactile stimulation; n = 59 control); demographics did not differ (P > .05) between groups. MBPS scores did not differ between groups: mean = 7.2 (standard deviation = 2.4) versus 7.6 (1.9); P = .245. Conclusion. Tactile stimulation cannot be recommended as a strategy to reduce vaccination pain in infants because of insufficient evidence of a benefit. [ABSTRACT FROM PUBLISHER]

Background. Omega-3 fatty acids supplements lower triglyceride (TG) levels in adults; little pediatric information is available. We evaluated their effect in hypertriglyceridemic adolescents. Methods. Twenty-five patients aged 10 to 19 years with TG levels 150 to 1000 mg/dL were randomized to 6 months double-blind trial of Lovaza (~3360 mg docosahexaenoic acid + eicosapentaenoic acid per day) versus placebo. Results. Baseline mean TG levels were 227 mg/dL (standard deviation = 49). TG levels declined at 3 months in the Lovaza group by 54 ± 27 mg/dL (mean ± standard error; P = .02) and by 34 ± 26 mg/dL (P = .16) in the placebo group. The difference in TG lowering between groups was not significant (P = .52). There were no between-group differences in endothelial function, blood pressure, body mass index, C-reactive protein, or side effects. Conclusions. High-dose omega-3 fatty acid supplements are well tolerated in adolescents. However, declines in TG levels did not differ significantly from Placebo in this small study. [ABSTRACT FROM PUBLISHER]