Medication-related visits in a pediatric emergency department: an 8-years retrospective analysis.

BACKGROUND: There are limited data on the characterization of medication-related visits (MRVs) to the emergency department (ED) in pediatric patients in Italy. We have estimated the frequency, severity, and classification of MRVs to the ED in pediatric patients. METHODS: We retrospectively analyzed data for children seeking medical evaluation for a MRV over an 8 years period. A medication-related ED visit was identified by using a random pharmacist assessment, emergency physician assessment, and in case of conflicting events, by a third investigators random assessment. RESULTS: In this study, regarding a single tertiary center in Italy, on a total of 147,643 patients from 0 to 14 years old, 497 medication-related visits were found, 54% of which occurred in children from 0 to 2 years of age. Severity was classified as mild in 21.6% of cases, moderate in 67.2% of cases, and severe in 11.2% of cases. The most common events were related to drug use without indication (51%), adverse drug reactions (30.3%), supratherapeutic dosage (13.2%) and improper drug selection (4.5%). The medication classes most frequently implicated in an ADE were anti-infective drugs for systemic use (28.9%), central nervous system agents (22.3%) and respiratory system drugs (10.8%). The most common symptom manifestations were dermatologic conditions (46.1%), general disorder and administration site conditions (29.7%) and gastrointestinal symptoms (16.0%). CONCLUSIONS: To our knowledge, this is the first study in Italy evaluating the epidemiologic characteristics of MRVs confirming a significant cause of healthcare contact resulting in ED visits and hospital admissions with associated resource utilization. Our results suggests further future prospective, large-sample sized, and multicenter research is necessary to better understand the impact of MRVs and to develop strategies to provide care plans and monitor patients to prevent medication-related visits. TRIAL REGISTRATION: Not applicable.

Oral Ondansetron versus Domperidone for Acute Gastroenteritis in Pediatric Emergency Departments: Multicenter Double Blind Randomized Controlled Trial.

The use of antiemetics for vomiting in acute gastroenteritis in children is still a matter of debate. We conducted a double-blind randomized trial to evaluate whether a single oral dose of ondansetron vs domperidone or placebo improves outcomes in children with gastroenteritis. After failure of initial oral rehydration administration, children aged 1-6 years admitted for gastroenteritis to the pediatric emergency departments of 15 hospitals in Italy were randomized to receive one oral dose of ondansetron (0.15 mg/kg) or domperidone (0.5 mg/kg) or placebo. The primary outcome was the percentage of children receiving nasogastric or intravenous rehydration. A p value of 0.014 was used to indicate statistical significance (and 98.6% CI were calculated) as a result of having carried out two interim analyses. 1,313 children were eligible for the first attempt with oral rehydration solution, which was successful for 832 (63.4%); 356 underwent randomization (the parents of 125 children did not give consent): 118 to placebo, 119 to domperidone, and 119 to ondansetron. Fourteen (11.8%) needed intravenous rehydration in the ondansetron group vs 30 (25.2%) and 34 (28.8%) in the domperidone and placebo groups, respectively. Ondansetron reduced the risk of intravenous rehydration by over 50%, both vs placebo (RR 0.41, 98.6% CI 0.20-0.83) and domperidone (RR 0.47, 98.6% CI 0.23-0.97). No differences for adverse events were seen among groups. In a context of emergency care, 6 out of 10 children aged 1-6 years with vomiting due to gastroenteritis and without severe dehydration can be managed effectively with administration of oral rehydration solution alone. In children who fail oral rehydration, a single oral dose of ondansetron reduces the need for intravenous rehydration and the percentage of children who continue to vomit, thereby facilitating the success of oral rehydration. Domperidone was not effective for the symptomatic treatment of vomiting during acute gastroenteritis.

The impact of the Italian guidelines on antibiotic prescription practices for acute otitis media in a paediatric emergency setting.

BACKGROUND: Acute otitis media (AOM) is one of the most common childhood infectious diseases. The recent Italian Pediatric Guidelines for the treatment of AOM constitutes a step forward in the management of children with uncomplicated AOM. The aim of this study was to evaluate antibiotic prescription patterns for AOM in a Pediatric Emergency Department (PED) after those guidelines were introduced and to assess the relationship between implementation of the "watchful waiting" strategy and the incidence of acute mastoiditis in the PED. METHODS: This retrospective study was conducted between 1st January 2007 to 31st December 2013 at the PED of the University of Modena and Reggio Emilia in Modena (Italy). All children between 0 and 14 years who were examined because of symptoms and/or signs of AOM and acute mastoiditis were enrolled. Pearson's chi-squared test was used to evaluate if introduction of the Italian Paediatric Guidelines was associated with a reduction in the antibiotic prescription pattern in children with AOM and/or with an increase in mastoiditis frequency. RESULTS: 4,573 (89.4%) patients were included in our analysis, antibiotics were prescribed to 81% cases of the children diagnosed with AOM. The frequency of antibiotic prescribing continued to be stable after the Italian guidelines were introduced (82% versus 81%). Forty children were admitted to hospital with a diagnosis of acute mastoiditis. Our study did not find any association between the number of cases of acute mastoiditis and the percentage of patients treated with antibiotics; the annual incidence of mastoiditis before and after the new guidelines were published was, in fact, stable. CONCLUSIONS: Despite the diffusion of clinical guidelines recommending a "watchful waiting" approach for children with AOM, the antibiotic prescription rate continues to be high. It appears to be more difficult to impact the percentage of cases for which antibiotics are prescribed than the type of antibiotic that is utilized. In view of these findings, a close follow-up control by the primary care paediatrician or a scheduled follow-up appointment at the PED and incisive campaigns to promote parents' awareness of proper antibiotic use appear to be warranted.

Oral ondansetron versus domperidone for symptomatic treatment of vomiting during acute gastroenteritis in children: multicentre randomized controlled trial.

BACKGROUND: Vomiting in children with acute gastroenteritis (AG) is not only a direct cause of fluid loss but it is also a major factor of failure of oral rehydration therapy (ORT). Physicians who provide care to paediatric patients in the emergency department (ED) usually prescribe intravenous fluid therapy (IVT) for mild or moderate dehydration when vomiting is the major symptom. Thus, effective symptomatic treatment of vomiting would lead to an important reduction in the use of IVT and, consequently, of the duration of hospital stay and of frequency of hospital admission. Available evidence on symptomatic treatment of vomiting shows the efficacy of the most recently registered molecule (ondansetron) but a proper evaluation of antiemetics drugs largely used in clinical practice, such as domperidone, is lacking. OBJECTIVES: To compare the efficacy of ondansetron and domperidone for the symptomatic treatment of vomiting in children with AG who have failed ORT. METHODS/DESIGN: Multicentre, double-blind randomized controlled trial conducted in paediatric EDs. Children aged from 1 to 6 years who vomiting, with a presumptive clinical diagnosis of AG, and without severe dehydration will be included. After the failure of a initial ORS administration in ED, eligible children will be randomized to receive: 1) ondansetron syrup (0,15 mg/Kg of body weight); 2) domperidone syrup (0,5 mg/Kg of body weight); 3) placebo. The main study outcome will be the percentage of patients needing nasogastric or IVT after symptomatic oral treatment failure, defined as vomiting or fluid refusal after a second attempt of ORT. Data relative to study outcomes will be collected at 30 minute intervals for a minimum of 6 hours. A telephone follow up call will be made 48 hours after discharge. A total number of 540 children (i.e. 180 patients in each arm) will be enrolled. DISCUSSION: The trial results would provide evidence on the efficacy of domperidone, which is largely used in clinical practice despite the lack of proper evaluation and a controversial safety profile, as compared to ondansetron, which is not yet authorized in Italy despite evidence supporting its efficacy in treating vomiting. The trial results would contribute to a reduction in the use of IVT and, consequently, in hospital admissions in children with AG. The design of this RCT, which closely reflect current clinical practice in EDs, will allow immediate transferability of results. TRIAL REGISTRATION: ClinicalTrials.gov: NCT01257672.

Severe syncope and sudden death in children with inborn salt-losing hypokalaemic tubulopathies.

BACKGROUND: Potassium deficiency may cause cardiac arrhythmias culminating in syncope or sudden death. METHODS: An inquiry performed among physicians caring for a total of 249 patients with inborn salt-losing tubulopathies revealed that acute cardiac complications occurred in seven children. RESULTS: Four patients died suddenly and three had severe syncope. These episodes occurred in the context of severe chronic hypokalaemia (< or =2.5 mmol/l) or were precipitated by acute diseases, which exacerbated hypokalaemia (< or =2.0 mmol/l). CONCLUSIONS: In conclusion, severe chronic or acute hypokalaemia is hazardous in inborn salt-losing tubulopathies.

Acute hepatitis in course of rotavirus gastroenteritis: a case report.

We report a case of an immunocompetent child with acute rotavirus gastroenteritis who developed an acute liver damage during infection. Acute rotavirus-related hepatitis has been previously described in immunodeficient children, but never in a normal child.

Risk of non-Hodgkin lymphoma in celiac disease.

CONTEXT: Celiac disease is one of the most common lifelong disorders. Non-Hodgkin lymphoma is a possible complication of celiac disease and may lead to a large portion of lymphoma cases. OBJECTIVE: To quantify the risk for developing non-Hodgkin lymphoma of any primary site associated with celiac disease. DESIGN AND SETTING: Multicenter, case-control study conducted between January 1996 and December 1999 throughout Italy. PATIENTS: Cases were older than 20 years (median, 57; range, 20-92 years) with non-Hodgkin lymphoma of any primary site and histological type and were recruited at the time of the diagnosis. Controls were healthy adults (2739 men and 2981 women) from the general population. MAIN OUTCOME MEASURE: Positive test result for class A serum antiendomysial antibody. RESULTS: Celiac disease was diagnosed in 6 (0.92%) of 653 patients with lymphoma. Of the 6 cases, 3 were of B-cell and 3 were of T-cell origin. Four of 6 cases had lymphoma primarily located in the gut. In the control group, 24 (0.42%) had celiac disease. The odds ratio (adjusted for age and sex) for non-Hodgkin lymphoma of any primary site associated with celiac disease was 3.1 (95% confidence interval [CI], 1.3-7.6), 16.9 (95% CI, 7.4-38.7) for gut lymphoma, and 19.2 (95% CI, 7.9-46.6) for T-cell lymphoma, respectively. The risk for non-Hodgkin lymphoma for the overall population, which was adjusted for age and sex, was 0.63% (95% CI, - 0.12% to 1.37%). CONCLUSION: Celiac disease is associated with an increased risk for non-Hodgkin lymphoma, especially of T-cell type and primarily localized in the gut. However, the association does not represent a great enough risk to justify early mass screening for celiac disease.