Ondansetron Safety Regarding Prolong QTc for Children with Head Trauma.

BACKGROUND: There have been recent reports of increased QT interval after head trauma in concussed athletes and adult patients. Ondansetron, which is widely used in treatment of nausea and vomiting symptoms in head injuries, was issued a safety warning from the U.S. Food and Drug Administration regarding QT prolongation and risk of fatal dysrhythmias. OBJECTIVE: The purpose of this study was to evaluate the safety of ondansetron regarding QT prolongation for patients experiencing nausea or vomiting after head trauma. METHODS: Patients aged 1-20 years presenting to a pediatric emergency department with head trauma and who required a dose of ondansetron for nausea or vomiting were enrolled in the study. Patients received a baseline 12-lead electrocardiogram (ECG) prior to administration of either oral or IV ondansetron. A second post-ondansetron 12-lead ECG was performed after administration of ondansetron. All ECGs were reviewed and the QTc calculated manually by a board-certified pediatric cardiologist. RESULTS: Forty-two patients met enrollment criteria. Five patients received IV ondansetron and 37 received oral ondansetron. Mean QTc pre ondansetron was 387.5 ms and mean QTc post ondansetron was 400.9 ms (p = 0.120). We found no statistically significant difference in other ECG parameters pre and post ondansetron. CONCLUSIONS: Ondansetron is safe in regard to QTc prolongation in patients with head trauma. Based on this research, ondansetron should continue to be used for the treatment of nausea and vomiting in emergency department patients who present with head injury.

Single-Dose Dexamethasone Is Not Inferior to 2 Doses in Mild to Moderate Pediatric Asthma Exacerbations in the Emergency Department.

OBJECTIVE: The purpose of this study was to compare the efficacy of a single dose of dexamethasone to 2 doses of dexamethasone in treating mild to moderate asthma exacerbations in pediatric patients. We anticipated that there would not be a difference in the rate of return visits to the emergency department (ED), urgent care, or primary care physician for continued asthma symptoms. METHODS: This was a prospective, randomized, single-center, unblinded, parallel-group randomized clinical trial of patients 2 to 20 years old presenting to a pediatric ED with mild to moderate asthma exacerbations. The patients were randomized to receive 1 or 2 doses of dexamethasone (0.6 mg/kg per dose, maximum of 16 mg). Telephone follow-up interviews were performed on the sixth day after ED visit. The primary outcome measures were return visits to either primary care physician or ED for continued asthma symptoms. Secondary outcomes were days of symptoms, missed school days, and adverse effects. RESULTS: Of the 318 children initially enrolled, 308 patients met the enrollment criteria. These patients were randomized into 2 groups. There were 116 patients in group 1 and 116 patients in group 2. There was no significant difference between groups regarding return visits (group 1, 12.1%; group 2, 10.3%; odds ratio [OR], 0.892 [95% confidence interval {CI}, 0.377-2.110]), days to symptom resolution (group 1, 2.4; group 2, 2.5; OR, 0.974 [95% 95% CI, 0.838-1.132]), missed school days (group 1, 47%; group 2, 51%; OR, 1.114 [95% CI, 0.613-2.023]), or vomiting (group 1, 8.6%; group 2, 3.4%; OR, 2.424 [95% CI, 0.637-9.228]). CONCLUSIONS: In this single-center, unblinded randomized trial of children and adolescents with mild to moderate acute exacerbations of asthma, there was no difference in the rate of return visits for continued or worsened symptoms between patients randomized to 1 or 2 doses of dexamethasone.

Do Your Kids Vape?: Investigating Parent Knowledge of Adolescent e-Cigarette Use.

OBJECTIVE: This study aimed to evaluate parental knowledge of their adolescent's e-cigarette use and their awareness of negative effects. METHODS: Participants were English-speaking 12- to 18-year-old patients and their guardians presenting to a pediatric emergency department. Patients and guardians were invited to complete a survey detailing e-cigarette use, parental awareness, and the understanding of risks. Participants were given separate surveys. They were monitored by research assistants in the room to ensure that answers were kept private. χ2 Analysis was used to interpret the data. RESULTS: A total of 309 paired surveys were obtained over an 8-month period. Of adolescents surveyed, 85 (27.5%) admitted to having ever used an e-cigarette and 33 (10.7%) admitted to regular use. Regular usage was defined as use within the last 30 days. Of the adolescents who used e-cigarettes, the majority (77.8%) had never smoked a traditional cigarette before. For teens who used e-cigarettes, 71.8% of their respective guardians were aware. When the adolescent reported that they did not use e-cigarettes, 91.3% of guardians responded that they did not believe their child was using the device. Guardians were somewhat worse at knowing if their child regularly used e-cigarettes, with only 54.8% of parents reporting to think that their child regularly uses. Finally, both adolescents and guardians reported to know that e-cigarette use was harmful. On a scale of 1 to 5, with 5 being the worst, 83.5% and 88.3% of patients and guardians, respectively, rated e-cigarette usage harm at 4 or 5. CONCLUSIONS: It seems guardians are generally aware of their adolescent's e-cigarette use, and both parents and adolescents are aware of the negative side effects of e-cigarettes on health. We did not investigate whether guardians discussed their concerns on e-cigarette usage with their adolescents. It is also unclear what specific health consequences guardians and adolescents are aware of. These may be points of further investigation and intervention.

Using Low-Cost Models for Training First-Year Pediatric Residents on 4 Accreditation Council for Graduate Medical Education-Required Procedures: A Pilot Study.

OBJECTIVES: The aims of the study were to assess the feasibility of using low-cost models to train first-year pediatric residents and to examine whether residents who receive such training will be as competent as their experienced colleagues in performing 4 American College of Graduate Education-required procedures, including suturing, splinting, lumbar puncture, and venipuncture. METHODS: We performed a pilot study with postgraduate year (PGY) 1 to 3 residents. Postgraduate year 1 residents completed a self-assessment questionnaire before the onset of training. A lecture was given to all PGY levels residents about procedural techniques. The PGY-1 residents practiced these techniques on low-fidelity models immediately after the lecture. One and 9 months after the initial lecture, all residents were assessed on these models using a 10-point checklist for each skill. RESULTS: Thirteen PGY-1 residents, 10 PGY-2 residents, and 10 PGY-3 residents completed the study. There was no statistically significant difference in performance of PGY-1 residents when compared with PGY-2 and PGY-3 residents in performing lumbar puncture, venipuncture, and suturing on models in the initial assessment that was performed 1 month after the lecture. Postgraduate year 1 residents performed equally well to PGY-3 residents and significantly (P < 0.05) better than PGY-2 residents, in splinting.There was no statistically significant difference between groups at final follow-up, supporting that training on models could help enhance proficiency among residents. CONCLUSIONS: This pilot study supports the feasibility of using low-cost models to train residents on invasive and painful procedures. Furthermore, residents trained on models showed maintenance of skills for a 9-month period.

Trimethoprim-Sulfamethoxazole Therapy Reduces Failure and Recurrence in Methicillin-Resistant Staphylococcus aureus Skin Abscesses after Surgical Drainage.

OBJECTIVE: To determine whether a 3-day vs 10-day course of antibiotics after surgical drainage of skin abscesses is associated with different failure and recurrence rates. STUDY DESIGN: Patients age 3 months to 17 years seeking care at a pediatric emergency department with an uncomplicated skin abscess that required surgical drainage were randomized to receive 3 or 10 days of oral trimethoprim-sulfamethoxazole therapy. Patients were evaluated 10-14 days later to assess clinical outcome. Patients were followed for 6 months to determine the cumulative rate of recurrent skin infections. RESULTS: Among the 249 patients who were enrolled, 87% of wound cultures grew Staphylococcus aureus (S aureus) (55% methicillin-resistant S aureus [MRSA], 32% methicillin-sensitive S aureus), 11% other organisms, and 2% no growth. Thirteen patients experienced treatment failure. Among all patients, no significant difference in failure rates between the 3- and 10-day treatment groups was found. After we stratified patients by the infecting organism, only patients with MRSA infection were more likely to experience treatment failure in the 3-day group than the 10-day group (P = .03, rate difference 10.1%, 95% CI 2.1%-18.2%) Recurrent infection within 1 month of surgical drainage was more likely in patients infected with MRSA who received 3 days of antibiotics. (P = .046, rate difference 10.3%, 95% CI 0.8%-19.9%). CONCLUSION: Patients with MRSA skin abscesses are more likely to experience treatment failure and recurrent skin infection if given 3 rather than 10 days of trimethoprim-sulfamethoxazole after surgical drainage. TRIAL REGISTRATION: ClinicalTrials.gov: NCT02024867.

Clinical signs and symptoms associated with intussusception in young children undergoing ultrasound in the emergency room.

OBJECTIVE: The purpose of this study was to evaluate all patients suspected of having intussusception and identify which signs and symptoms were associated with the disease. METHODS: We performed a retrospective review of 553 charts from 2006 to 2010 of patients' age 2 months to 5 years who had an abdominal ultrasound obtained to evaluate for intussusception. Charts were reviewed for signs and symptoms previously shown to be associated with intussusception. RESULTS: There were 452 patients (mean age, 21.5 months, 43% female) evaluated and 101 (22.3%) were found to have intussusception. Of the 18 signs and symptoms, crying (adjusted odds ratio [OR], 3.3; 95% confidence interval [95% CI], 1.3-8.1), abdominal mass (adjusted OR, 15.7; 95% CI, 4.4-55.3), pallor (adjusted OR, 6.5; 95% CI, 1.8-23.5), and vomiting (adjusted OR, 3.1; 95% CI, 1.4-6.5) were associated with disease confirmation in logistic regression analysis. The presence of all 4 clinical signs/symptoms together resulted in a 95% probability of intussusception. Intussusception was unlikely if all 4 clinical indicators were absent (probability = 1.6%). CONCLUSIONS: The presence of crying, abdominal mass, pallor, and vomiting were clinical indicators of intussusception. Individually, none of these variables were helpful in confirming the diagnosis but in the presence of all 4, there is a 95% probability of having the disease. The absence of all 4 of these made the likelihood of having the disease very low.

A brief introduction to institutional review boards in the United States.

China has become one of the main fields for international drug and device trials in the last twenty years. Although China has greatly strengthened the protection of human research participants over this time, there is still room for improvement. In order for Chinese investigators to participate in international clinical trials, compliance with internationally recognized ethical regulations is essential. In the United States (U.S.), research involving human subjects is reviewed by an ethics committee called the Institutional Review Board (IRB). In this article, we briefly introduce the background, composition, and function of the IRB in the U.S. to our Chinese investigators.

A comparison of the effects of oral inoculation with Rotashield and pentavalent reassortant rotavirus vaccine (WC3-PV) on suckling CB17scid mice.

The effects of oral inoculation into infant CB17(scid) mice of two reassortant rotavirus vaccines were compared. The vaccines were Rotashield and WC3-PV, a mixture of five reassortants (G1, G2, G3, G4 and P1; pentavalent reassortant vaccine). Control mice were inoculated with a placebo. At 6 days post-inoculation (p.i.), 8 of 13 (62 %; P<0.005) Rotashield-inoculated mice developed hepatitis and/or bile-duct obstruction compared with none of 11 mice given WC3-PV and none of 14 given placebo. In the Rotashield-inoculated mice, only serotype G3 rhesus rotavirus (RRV) was isolated from multiple sites, including intestine, liver, pancreas, spleen, blood and mesenteric lymph nodes. Recovery of RRV from Rotashield-inoculated mice followed a biphasic pattern. The two peaks of RRV recovery appeared to coincide firstly with replication in the intestine during days 1-3 p.i., and secondly with virus infection of the liver from days 10 to 15 p.i. WC3 reassortants of four different serotypes were detected only at day 1 p.i. in the intestine, liver, pancreas and blood cells from three WC3-PV-inoculated mouse pups. However, WC3-PV did not produce any hepatopathology. Rotashield and WC3-PV appeared to exhibit different biological activity in infant CB17(scid) mouse pups.

Immune responses in rhesus rotavirus-challenged BALB/c mice treated with bifidobacteria and prebiotic supplements.

Bifidobacterium species (B. bifidum and B. infantis), with or without prebiotic compounds (arabino-galactan, short-chain fructo-oligosaccharide, iso-malto-dextrins), were orally fed to Balb/c pups (n = 192) to evaluate their potential synergistic effects on modulating the course of rhesus rotavirus (RRV) infection, as well as their ability to mediate the associated mucosal and humoral immune responses. Rotavirus-specific IgA and IgG in serum, rotavirus antigen, and specific IgA in feces were measured by ELISA. Mucosal total IgA and IgG levels were determined in Peyer's patches by flow cytometry. Significantly delayed onset (p = 0.001) and early resolution (p < 0.001) of diarrhea were observed in bifidobacteria-treated, RRV-infected mice compared with RRV-infected control mice. Supplementation with prebiotic compounds did not shorten the clinical diarrhea course more than that observed with bifidobacteria treatment alone. Rotavirus-specific IgA in feces was 16-fold elevated on d 5 postinfection in bifidobacteria-treated, RRV-infected mice compared with the RRV-infected alone group. In addition, the level of rotavirus-specific IgA in serum was four-fold higher in bifidobacteria-treated, RRV-infected litters versus mice challenged with RRV alone on 28 and 42 d postinfection. No enhancement of the immune response was found in RRV-infected mice that were treated with both bifidobacteria and prebiotic compounds over those treated with bifidobacteria only. The findings suggest that bifidobacteria may act as an adjuvant by modulating early mucosal and strong humoral rotavirus-specific immune responses, and mitigate severity of rotavirus-induced diarrhea.

In vivo effects of bifidobacteria and lactoferrin on gut endotoxin concentration and mucosal immunity in Balb/c mice.

The aim of the present study was to examine the effects of oral supplementation of newborn Balb/c mice with bifidobacteria (B. infantis, B. bifidum) and iron-free apo-lactoferrin (bovine, human) on gut endotoxin concentration and mucosal immunity. Endotoxin concentration was measured in ileocecal filtrates at 7, 14, 21, and 28 days postdelivery by a quantitative limulus amebocyte lysate test. While endotoxin levels in bifidobacteria-fed mice showed a steady rise over time, they were consistently lower than that observed in control animals. Results of lactoferrin supplementation varied depending on the specific time point, but overall by day 28, all treatment groups showed lower intestinal endotoxin concentrations compared to saline fed animals. Neither bifidobacteria nor lactoferrin stimulated an increase in B or T cells, or in cytokine production (IL-6, TNF-alpha, INF-gamma), in Peyer's patches as measured by flow cytometry. Bifidobacteria and lactoferrin were well tolerated as dietary supplements and showed promising potential to reduce gut endotoxin levels.

In vitro growth responses of bifidobacteria and enteropathogens to bovine and human lactoferrin.

A series of in vitro experiments was performed to test the ability of bovine and human lactoferrin to influence the growth of the gram-positive probiotic bacteria, Bifidobacterium bifidum, Bifidobacterium infantis, and Lactobacillus acidophilus, as well as the gram-negative enteric bacteria, E. coli O157:H7 and Salmonella typhimurium. None of the lactoferrin preparations stimulated the growth of the tested strains. However, iron-free apo-lactoferrin (bovine and human) and 66% iron-saturated bovine lactoferrin dramatically slowed the growth of E. coli O157:H7 in single culture experiments, while 98% iron-saturated preparations had no effect. In coculture experiments of B. infantis and E. coli, the iron-limited preparations of lactoferrin also slowed the growth of the latter without inhibiting the bifidobacteria. These results suggest that lactoferrin in iron-limited forms may have the potential to be combined with probiotic bacteria in biotherapeutic products, which could help balance human gut microflora and limit the overgrowth of certain enteric microorganisms.