Increasing awareness of food-choking and nutrition in children through education of caregivers: the CHOP community intervention trial study protocol.

BACKGROUND: Choking is one of the leading causes of death among unintentional injuries in young children. Food choking represents a considerable public health burden, which might be reduced through increased effective preventative education programs. We present a protocol for a community intervention trial termed CHOP (CHOking Prevention project) that aimed to teach Italian families how to prevent food choking injuries and increase knowledge relating to nutrition. METHODS: Italian educational facilities were enrolled. Stratified randomization blocked by geographical area was performed. Each stratum was randomized to one of three different intervention strategies or to a control group. Educational intervention was delivered in the schools by experts and certified trainers as per the following three intervention strategies: directly to families (Strategy A); to teaching staff only, who subsequently delivered the same educational intervention to families (Strategy B); to health service staff only, who then delivered the educational intervention to teaching staff, who subsequently delivered the intervention to families (Strategy C). Participants completed a questionnaire about their knowledge on the topics presented during the educational interventions (pre-, post-, and follow-up of intervention). Information from the questionnaires was synthetized into 6 indicators in order to measure how effective each intervention strategy was. DISCUSSION: The issue of food choking injuries in children is relevant to public health. The protocol we present provides an opportunity to progress towards overcoming such challenges through a working model that can be implemented also in other countries. TRIAL REGISTRATION: ClinicalTrials.gov NCT03218618. The study was registered on 14 July 2017.

Nationwide study of headache pain in Italy shows that pain assessment is still inadequate in paediatric emergency care.

AIM: Italian national guidelines on pain management were published in 2010, but there is little information on how effective pain management is in paediatric emergency care, with other countries reporting poor levels. Using headache as an indicator, we described pain assessment in Italian emergency departments and identified predictors of algometric scale use. METHODS: All Italian paediatric and maternal and child hospitals participated, plus four general hospitals. Data on all children aged 4-14 years admitted during a one-month period with headache as their chief complaint were abstracted from clinical records. Multivariable analyses identified predictors of algometric assessment, taking into account the cluster study design. RESULTS: We studied 470 admissions. During triage, pain was assessed using a standardised scale (41.5%), informally (15.5%) or was not recorded (42.9%). Only 32.1% of the children received analgesia in the emergency department. The odds ratios for predictors of algometric assessment were non-Italian nationality (3.6), prehospital medication (1.8), admission to a research hospital (7.3) and a more favourable nurses-to-admissions ratio of 10.8 for the highest versus lowest tertile. CONCLUSION: Despite national guidelines, paediatric pain assessment in Italian emergency care was suboptimal. Hospital variables appeared to be stronger predictors of adequate assessment than patient characteristics.

Off-label prescribing patterns of antiemetics in children: a multicenter study in Italy.

UNLABELLED: Acute gastroenteritis (AG) represents both the main cause of acute vomiting in children under 3 years old and a major cause of access to the emergency department. Even if several drugs may be able to reduce the emesis, the pharmacological treatment of vomiting in children remains a controversial issue, and several drugs are prescribed outside their authorized drug label with respect dosage, age, indication, or route of administration and are named as off-label. The aim of present study was to assess the off-label use of antiemetic drugs in patients less than 18 years with vomiting related to AG. This study was carried out in eight pediatric emergency departments in Italy. The following data were obtained crossing the pharmacy distribution records with emergency departments' patient data: sex and age of the patients and detailed information for each drug used (indication, dose, frequency, and route of administration). We recorded that antiemetic drugs were prescribed in every year, particularly in children up to 2 years old, and compared with both literature data and data sheet; 30 % of the administered antiemetics were used off-label. In particular, domperidone was the only antiemetic used labeled for AG treatment in pediatric patients, while metoclopramide and ondansetron have been off-label for both age and indications (i.e., AG treatment). CONCLUSIONS: In conclusion, we documented an off-label use of antiemetics in children, and this could represents a problem of safety for the patient and a legal risk for the prescribing physician if patients have an unwanted or bad outcome from treatment.

Pain management policies and practices in pediatric emergency care: a nationwide survey of Italian hospitals.

BACKGROUND: Pain experienced by children in emergency departments (EDs) is often poorly assessed and treated. Although local protocols and strategies are important to ensure appropriate staff behaviours, few studies have focussed on pain management policies at hospital or department level. This study aimed at describing the policies and reported practices of pain assessment and treatment in a national sample of Italian pediatric EDs, and identifying the assocoated structural and organisational factors. METHODS: A structured questionnaire was mailed to all the 14 Italian pediatric and maternal and child hospitals and to 5 general hospitals with separate pediatric emergency room. There were no refusals. Information collected included the frequency and mode of pain assessment, presence of written pain management protocols, use of local anaesthetic (EMLA cream) before venipuncture, and role of parents. General data on the hospital and ED were also recorded. Multiple Correspondence Analysis was used to explore the multivariable associations between the characteristics of hospitals and EDs and their pain management policies and practices. RESULTS: Routine pain assessment both at triage and in the emergency room was carried out only by 26% of surveyed EDs. About one third did not use algometric scales, and almost half (47.4%) did not have local protocols for pain treatment. Only 3 routinely reassessed pain after treatment, and only 2 used EMLA. All EDs allowed parents' presence and most (17, 89.9%) allowed them to stay when painful procedures were carried out. Eleven hospitals (57.9%) allowed parents to hold their child during blood sampling. Pediatric and maternal and child hospitals, those located in the North of Italy, equipped with medico-surgical-traumatological ED and short stay observation, and providing full assessment triage over 24 hours were more likely to report appropriate policies for pain management both at triage and in ER. A nurses to admissions ratio ≥ median was associated with better pain management at triage. CONCLUSIONS: Despite availability of national and international guidelines, pediatric pain management is still sub-optimal in Italian emergency departments. Multifaceted strategies including development of local policies, staff educational programs, and parental involvement in pain assessment should be carried out and periodically reinforced.

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.

Assessing school-based intervention strategies to foster the prevention of choking injuries in children: The results of the CHOP (CHOking Prevention) trial.

There are few public health programs aimed at reducing choking injuries, even though choking is one of the leading causes of death among unintentional injuries in young children. We present the results from the CHOP (CHOking Prevention) project community intervention trial, which aimed to compare three different school-based intervention strategies for food choking prevention. The trial enrolled 41 educational facilities, which were randomized to one of three different intervention strategies to inform about prevention of food choking, or to serve as the control group. In strategy A, education was delivered directly to families, whereas in strategy B, education was delivered first to teachers and by them to families, and in strategy C, education was delivered only to healthcare coordinators in each school and by them to teachers and families. All educational interventions were delivered in the schools by experts and certified trainers. The participants were asked about sociodemographic information and completed questionnaires (pre-, post- and follow-up of intervention). Information from the postintervention and follow-up questionnaires was synthesized into four indicators to evaluate the effectiveness of each intervention strategy. Of the 1,426 participants, 298 were involved in strategy A, 474 in strategy B, 491 in strategy C and 163 in the control group. At postintervention, the scores of the indicators in each strategy significantly outperformed those of the control group, with adjusted p < 0.05. At follow-up, the distribution of the indicator scores of each strategy was found to be not significantly different compared to those of the control group (p > 0.05). The results of this study suggest that a sustainable school-based public health intervention mediated by teachers is effective as direct training for families in improving knowledge about food choking injury prevention. Nevertheless, further improvements could be made to increase long-term information retention.

Sublingual ketorolac versus sublingual tramadol for moderate to severe post-traumatic bone pain in children: a double-blind, randomised, controlled trial.

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<0.001). The mean pain scores for ketorolac were lower than those for tramadol, but these differences were not significant at any time point (Mann-Whitney U Test, p values: 0-20 min: 0.167; 20-40 min: 0.314; 40-60 min: 0.223; 60-80 min: 0.348; 80-100 min: 0.166; 100-120 min: 0.08). The rescue dose of paracetamol-codeine was administered in 2/60 children in the ketorolac group versus 8/65 in the tramadol group (Fisher exact test, p=0.098). There were no statistically significant differences between the two groups in the frequency of adverse effects. CONCLUSIONS: Both sublingual ketorolac and tramadol were equally effective for pain management in children with suspected fractures or dislocations.

A descriptive study of injuries in a pediatric population of North-Eastern Italy.

Childhood injuries are a major public health problem in Italy. From a study conducted in 1984, injury rates were found to be higher in Trieste, in the north-east of the country, than in other Italian areas. We conducted a new study to evaluate whether injury rates and patterns have changed in Trieste. There are three emergency rooms (ER) in Trieste. We collected and analyzed information on all injured children 0-16 years of age attending these ER in 2003 (child population 0-16 years of age was 28,000). We calculated the annual injury risk overall and by age. We described characteristics of the children (age, sex) and injuries (place, cause, type, affected body part, severity). 5,928 injured children attended the ER, and the annual injury risk was 21.5%. The home was the most frequent place where injuries occurred, especially among the youngest children. The most commonly injured body parts were the limbs and, among the youngest children, the head and face. Approximately 20% of children had moderate to severe injuries (AIS>1), and less then 3% were admitted to the hospital. In comparison to the previous study, there have been no significant changes in the annual risk of childhood injury and in the injury patterns. On the contrary, we observed a dramatic reduction in the frequency of hospitalization, which is probably attributable to the recent implementation of short observation and to the improvement of diagnostic/therapeutic paths in the ER. In conclusion, childhood injuries are still a relevant public health problem in this Italian area and new efforts are needed to prevent them.

Predictors of intracranial injuries in children after blunt head trauma.

UNLABELLED: This study was conducted to determine if clinical features can predict the risk of intracranial injury (ICI) in pediatric closed head trauma. We enrolled 3,806 children under 16 years consecutively referred for acute closed head trauma to the paediatric emergency room of five Italian children's hospitals. Relevant outcomes were death and diagnosis of ICI. Clinical symptoms and signs were evaluated as possible outcome predictors. Children were also classified into five groups according to their clinical presentation. The association of ICI with signs and symptoms and the appropriateness of the five-group classification in predicting the likelihood of ICI were evaluated by logistic regression analyses. ICI was diagnosed in 22 children; 2 of them died. The risk of fatal and nonfatal ICI was 0.5 and 5.2 per 1,000 children with closed head trauma respectively. Significant associations were found between ICI and loss of consciousness, prolonged headache, persistent drowsiness, abnormal mental status, focal neurological signs, signs of skull fracture in non-frontal areas and signs of basal skull fracture. The five-group classification of children allowed an excellent prediction in terms of likelihood of ICI (ROC area 0.972). CONCLUSIONS: Selection of children with closed head trauma based on different combinations of signs and symptoms allows for early identification of subjects at different risk for ICI. In patients with minor head injuries, the absence of loss of consciousness, drowsiness, amnesia, prolonged headache, clinical evidence of basal or non-frontal skull fracture identified 100% of children without lesions. Validation of our results with a larger sample of patients with ICI would be highly desirable.