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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.

Rationale and aim The aim of the present study is to acquire a better understanding of Non Food Foreign Bodies (NFFB) injuries in children with particular regard to the quantification of the risk of complications and hospitalization associated with patient characteristics, FB features, FB location and circumstances of the accident, as emerging from the SUSY Safe Web-Registry. Methods The present study uses data provided by the SUSY Safe Project, a DG SANCO co-funded project which was aimed to collect as many scientific data as possible regarding Foreign Bodies (FB) injuries in children aged 0–14 years and to serve as a basis for a knowledge-based consumer protection activity in the Europe market. FBs were characterized by size, shape and consistency. Descriptive statistics (absolute and relative number or median, I and III quartile according to the categorical or continuous variable, respectively) were calculated for each considered non food item characteristics; FB features distribution by children class age and site of obstruction were assessed. Two different outcomes were considered: hospitalization and complication. FBs which most frequently cause complications were identified. The association between children age, adult presence, object characteristics and outcomes was computed using crude odds ratios and the related 95% confidence intervals. Results 16,878 FB injuries in children aged 0–14 yrs have been recorded in the Susy Safe databases. FB type was specified in 10,564 cases; among them 7820 (74%) were due to a non food item. Almost two thirds of injuries occurred in patients 3 years or more old. 53% of patients were males, while 47% were females. When injury happened, the great part of children (86%) was playing. Almost 30% (2339) of injuries happened under adults’ supervision. Complications occurred in 299 cases and the most documented was infections (10% of cases) followed by perforation (5%). Conclusions The inhalation/aspiration of a FB, as well as the ingestion and the insertion in the orifices of a FB may result in significant morbidity. Particularly, long-standing or hazardous foreign bodies can cause extensive damage. Some objects, because of their composition, contour, or location, are particularly hazardous: for instance, objects with sharp edges pose a significant risk of laceration and perforation, while fragments of toys have been found only in 2 cases. Parents are frequently unconscious of hazard related with some objects and they are not adequately able to promptly recognize dangerous objects and risky situations. Moreover, also clinicians seem to pay little attention to adult role in the dynamic of the accident: in fact in case series descriptions, data regarding adult presence are often under-reported. On the contrary, since many injuries to children cannot be prevented without some degree of active behavior on the part of parents, the dissemination of information regarding safe behaviors and the implementation of educational strategies aiming to improve parent's attention toward this issue could be fundamental in preventing injuries and need to be promoted by family pediatricians and health practitioners.

Objectives To provide an epidemiological framework of symptoms related to Foreign Body (FB) injuries due to Button Battery (BB). Methods Data on BB ingestion/inhalation have been obtained from the ButtonBatteryDB. The ButtonBatteryDB is a database collecting information on BB injuries in children (0–18 years of age). Data on 348 BB injures have been derived from the Registry of Foreign Body Injuries “Susy Safe” (269 cases) and from published scientific literature reporting case reports of FB injuries (79 cases). Results Most of injured children were male and BBs were found more often in the mouth/esophagus/stomach (ICD935) and in the nose (ICD932). Analyzing symptoms related to BB located in the esophagus/mouth/stomach, we found that children had higher probability of experiencing dysphagia (30.19%, 95% C.I. 17.83–42.55), fever and cough (26.42%, 95% C.I. 14.55–38.28), compared to the other symptoms. Referring to the probability that symptoms occurred simultaneously, fever and cough are more likely (3.72%, 95% C.I. 1.0–6-43) to jointly showing up in children with BB in mouth/esophagus/stomach (ICD935), followed by fever and dysphagia (2.66%, 95% C.I. 0.36–4.96) and by fever and irritability/crying, fever and drooling, dysphagia and irritability/crying (2.13% C.I. 0.00–4.19, 95% C.I.) Conclusions These findings provide new insight in clinical presentation of BB injuries: the identification of unique patterns of symptoms related to BB injuries is useful to perform an early diagnosis (and to guarantee a prompt medical reaction), also when the injury is un-witnessed.

Il singhiozzo è una contrazione spasmodica intermittente del diaframma e dei muscoli inspiratori accessori, accompagnata da una violenta inspirazione interrotta dalla chiusura improvvisa della glottide che causa il caratteristico rumore che lo caratterizza immediatamente, meglio di ogni descrizione più o meno scientifica.

Objective: An active surveillance system to estimate adverse drug and vaccine events in children is coordinated by the National Institute of Health in Italy. The study is conducted in some Italian paediatric hospitals and departments. Methods: The study includes children hospitalised through the Emergency Department for thrombocytopenia, esophageal and gastroduodenal lesions, neurological disorders, muco-cutaneous diseases. Drug exposure is retrieved through interview to parents. The association between drugs (or vaccines) and events is estimated with a case-control study design. Results: 2,887 children hospitalised have been enrolled from November 1999 to June 2006. A 2.2 risk of thrombocytopenia has been associated with antibiotics. An increased risk associated with MMR vaccine has been confirmed (OR 2.7). An increased risk of non febrile seizures has been associated with hexavalent vaccines (OR 2.7). Conclusion: The study confirmed and quantified recommendations coming from the spontaneous reporting system and it is an important support for the Italian national pharmacovigilance.

Rationale and aim: The purpose of this study is to acquire a better understanding of Food Foreign Bodies (FFB) injuries in children characterizing the risk of complications and prolonged hospitalization due to food items according to patients' characteristics, circumstances of the accident, Foreign Body (FB) features and FB location, as emerging from the SUSY Safe Web-Registry. Methods: The present study uses data provided by the SUSY Safe Project, a DG SANCO co-funded project started in February 2005, which was aimed at establishing an international registry of cases of Foreign Bodies (FB) injuries in children aged 0-14 years. The analysis was carried out on injuries due to a food item.FB location was reported according to ICD9-CM code: ears (ICD931), nose (ICD932), pharynx and larynx (ICD933) trachea, bronchi and lungs (ICD934), mouth, esophagus and stomach (ICD935).Age and gender injury distributions were assessed. Data regarding adult supervision and activity before injury were also evaluated. FBs which most frequently cause complications were identified. The association between children age, adult presence, object characteristics and hospitalization/complications was computed using unweighted odds ratios and the related 95% confidence intervals. Results: 16,878 FB injuries occurred in children aged 0-14 years have been recorded in the SUSY Safe databases. FB type was specified in 10,564 cases; among them 2744 (26%) were due to a food item. FB site was recorded in 1344 cases: FB was located in the ears in 99 patients, while 1140 occurred in the upper and lower respiratory tract; finally, 105 food items were removed from mouth, esophagus and stomach. Complications occurred in 176 cases and the most documented was pulmonary or bronchial infections (23%) followed emphysema or atelectasis and by and asthma (7%). Bones were the commonest retrieved FFB encountered in this study, while nuts seem to be the FFB most frequently associated to complications. Conclusions: On the basis of this study we make the strong recommendation that parents should be adequately educated and provide age-appropriate food to their children and be present in order to supervise them during eating especially during a critical period ranging from 2 to 3 years of age.

OBJECTIVES: To assess the effectiveness of sublingual ketorolac versus sublingual tramadol in reducing the pain associated with fracture or dislocation of extremities in children. PATIENTS AND METHODS: A double-blind, randomised, controlled, non-inferiority trial was conducted in the paediatric emergency department of a research institute. One hundred and thirty-one children aged 4-17 years with suspected bone fracture or dislocation were enrolled. Eligible children were randomised to ketorolac (0.5 mg/kg) and placebo, or to tramadol (2 mg/kg) and placebo by sublingual administration, using a double-dummy technique. Pain was assessed by the patients every 20 min, for a maximum period of 2 h, using the McGrath scale for patients up to 6 years of age, and the Visual Analogue Scale for those older than 6 years of age. RESULTS: The mean pain scores fell significantly from eight to four and five in the ketorolac and tramadol groups, respectively, by 100 min (Wilcoxon sign rank test, p