Hyoscine butylbromide versus acetaminophen for nonspecific colicky abdominal pain in children: a randomized controlled trial.

BACKGROUND: Less than two-thirds of children with abdominal pain in the emergency department receive analgesia. We sought to determine whether hyoscine butylbromide was superior to acetaminophen for children with nonspecific colicky abdominal pain. METHODS: We randomly allocated children aged 8-17 years with nonspecific colicky abdominal pain who presented to the pediatric emergency department of London Health Sciences Centre, London, Ontario to receive hyoscine butylbromide, 10 mg given orally, or acetaminophen, 15 mg/kg given orally (maximum 975 mg). We considered the minimal clinically important difference for the primary outcome (self-reported pain at 80 min) to be 13 mm on a 100 mm visual analogue scale. Secondary outcomes included administration of rescue analgesia, adverse effects and pain score less than 30 mm at 80 minutes. RESULTS: A total of 236 participants (120 in the hyoscine butylbromide group and 116 in the acetaminophen group) were included in the trial. The mean visual analogue scale scores at 80 minutes were 29 mm (standard deviation [SD] 26 mm) and 30 mm (SD 29 mm) with hyoscine butylbromide and acetaminophen, respectively (adjusted difference 1, 95% confidence interval -7 to 7). Rescue analgesia was administered to 4 participants (3.3%) in the hyoscine butylbromide group and 1 participant (0.9%) in the acetaminophen groups (p = 0.2). We found no significant differences in rates of adverse effects between hyoscine butylbromide (32/116 [27.6%]) and acetaminophen (28/115 [24.3]) (p = 0.5); no serious adverse effects were observed. The proportion with a pain score less than 30 mm at 80 minutes was 66 (55.0%) with hyoscine butylbromide and 63 (54.3%) with acetaminophen (p = 0.9). INTERPRETATION: Hyoscine butylbromide was not superior to acetaminophen in this setting. Both agents were associated with clinically important pain reduction, and either can be considered for children presenting to the emergency department with nonspecific colicky abdominal pain. Trial registration: Clinicaltrials.gov, no. NCT02582307.

Endogenous Glucocorticoid Response to Single-Dose Dexamethasone for Croup in Children: A Pharmacodynamic Study.

OBJECTIVES: Dexamethasone is associated with adrenal insufficiency in adults and children with chronic disease. This association has not been studied after single-dose oral dexamethasone, the standard of care for children with croup. We hypothesized that single-dose oral dexamethasone in children with croup is associated with a transient decrease in endogenous glucocorticoids. METHODS: We conducted a prospective, 2-arm, pharmacodynamic study of single-dose oral dexamethasone 0.6 mg/kg (maximum, 12 mg) in children older than 2 years with croup compared with controls (children with febrile upper respiratory tract infections who did not receive dexamethasone). Primary outcome was urinary 6ß-hydroxycortisol-cortisol ratio. RESULTS: Twenty-seven children were analyzed (22 with croup and 5 with upper respiratory tract infections). Median 6ß-hydroxycortisol-cortisol ratios before dexamethasone, the following morning, and on days 1, 3, and 7 were 2.8, 2.2, 2.0, 2.8, and 2.6, respectively. Among controls, the median 6ß-hydroxycortisol-cortisol ratios at the same time intervals was 1.9, 1.5, 1.8, 2.5, and 1.7, respectively. There were no significant differences in the change from time 0 between groups at any time point. There were no serious adverse events or infectious complications. CONCLUSIONS: Single-dose oral dexamethasone is not associated with decreased endogenous corticosteroid levels in children with croup. Future studies should use criterion standard tests to rule out suppression of the hypothalamic-pituitary-adrenal axis and be powered sufficiently to identify adverse clinical outcomes.

The impact of pediatric emergency department crowding on patient and health care system outcomes: a multicentre cohort study.

BACKGROUND: Emergency department overcrowding has been associated with increased odds of hospital admission and mortality after discharge from the emergency department in predominantly adult cohorts. The objective of this study was to evaluate the association between crowding and the odds of several adverse outcomes among children seen at a pediatric emergency department. METHODS: We conducted a retrospective cohort study involving all children visiting 8 Canadian pediatric emergency departments across 4 provinces between 2010 and 2014. We analyzed the association between mean departmental length of stay for each index visit and hospital admission within 7 days or death within 14 days of emergency department discharge, as well as hospital admission at index visit and return visits within 7 days, using mixed-effects logistic regression modelling. RESULTS: A total of 1 931 465 index visits occurred across study sites over the 5-year period, with little variation in index visit hospital admission or median length of stay. Hospital admission within 7 days of discharge and 14-day mortality were low across provinces (0.8%-1.5% and < 10 per 100 000 visits, respectively), and their association with mean departmental length of stay varied by triage categories and across sites but was not significant. There were increased odds of hospital admission at the index visit with increasing departmental crowding among visits triaged to Canadian Triage and Acuity Scale (CTAS) score 1-2 (odds ratios [ORs] ranged from 1.01 to 1.08) and return visits among patients with a CTAS score of 4-5 discharged at the index visit at some sites (ORs ranged from 1.00 to 1.06). INTERPRETATION: Emergency department crowding was not significantly associated with hospital admission within 7 days of the emergency department visit or mortality in children. However, it was associated with increased hospital admission at the index visit for the sickest children, and with return visits to the emergency department for those less sick.

Validation and refinement of a clinical decision rule for the use of computed tomography in children with minor head injury in the emergency department.

BACKGROUND: There is uncertainty about which children with minor head injury need to undergo computed tomography (CT). We sought to prospectively validate the accuracy and potential for refinement of a previously derived decision rule, Canadian Assessment of Tomography for Childhood Head injury (CATCH), to guide CT use in children with minor head injury. METHODS: This multicentre cohort study in 9 Canadian pediatric emergency departments prospectively enrolled children with blunt head trauma presenting with a Glasgow Coma Scale score of 13-15 and loss of consciousness, amnesia, disorientation, persistent vomiting or irritability. Phys icians completed standardized assessment forms before CT, including clinical predictors of the rule. The primary outcome was neurosurgical intervention and the secondary outcome was brain injury on CT. We calculated test characteristics of the rule and used recursive partitioning to further refine the rule. RESULTS: Of 4060 enrolled patients, 23 (0.6%) underwent neurosurgical intervention, and 197 (4.9%) had brain injury on CT. The original 7-item rule (CATCH) had sensitivities of 91.3% (95% confidence interval [CI] 72.0%-98.9%) for neurosurgical intervention and 97.5% (95% CI 94.2%-99.2%) for predicting brain injury. Adding "≥ 4 episodes of vomiting" resulted in a refined 8-item rule (CATCH2) with 100% (95% CI 85.2%-100%) sensitivity for neurosurgical intervention and 99.5% (95% CI 97.2%-100%) sensitivity for brain injury. INTERPRETATION: Among children presenting to the emergency department with minor head injury, the CATCH2 rule was highly sensitive for identifying those children requiring neurosurgical intervention and those with any brain injury on CT. The CATCH2 rule should be further validated in an implementation study designed to assess its clinical impact.

Treating and reducing anxiety and pain in the paediatric emergency department-TIME FOR ACTION-the TRAPPED quality improvement collaborative.

BACKGROUND/OBJECTIVES: In 2013, the TRAPPED-1 survey reported inconsistent availability of pain and distress management strategies across all 15 Canadian paediatric emergency department (PEDs). The objective of the TRAPPED-2 study was to utilize a procedural pain quality improvement collaborative (QIC) and evaluate the number of newly introduced pain and distress-reducing strategies in Canadian PEDs over a 2-year period. METHODS: A QIC was created to increase implementation of new strategies, through collaborative information sharing among PEDs. In 2015, 11 of the 15 Canadian PEDs participated in the TRAPPED QIC. At the end of the year, the TRAPPED-2 survey was electronically sent to a representative member at each of the 15 PEDs. The successful introduction of the chosen strategies by the QIC was assessed as well as the addition of new strategies per site. The number of new strategies introduced in the participating and nonparticipating QIC sites were described. RESULTS: All 15 PEDs (100%) completed the TRAPPED-2 survey. Overall, 10/11 of QIC-participating sites implemented the strategy they had initially identified. All 15 Canadian PEDs implemented some new strategies during the study period; participants in the QIC reported a mean of 5.2 (1-11) new strategies compared to 2.5 (1-4) in the nonactively participating sites. CONCLUSION: While all PEDs introduced new strategies during the study, QIC-participating sites successfully introduced the majority of their previously identified new strategies in a short time period. Sharing deadlines and information between centres may have contributed to this success.

Atypical Presentation of Right Ventricular Outflow Tract Ventricular Tachycardia.

BACKGROUND: Ventricular tachycardia (VT) in the pediatric population is rare, has a wide differential diagnosis, and can present in numerous ways. In the absence of underlying heart disease, VT is considered idiopathic and is associated with an excellent prognosis. Right ventricular outflow tract ventricular tachycardia (RVOT-VT) represents the most common form of idiopathic VT. The differential diagnosis, mechanism, presentation, management, and prognosis of RVOT-VT in the pediatric population will be discussed. CASE REPORT: We report a case of RVOT-VT that was incidentally discovered in an 11-year-old girl during an emergency department workup for severe headache. WHY SHOULD AN EMERGENCY PHYSICIAN BE AWARE OF THIS?: It is essential for emergency physicians to have an approach to pediatric VT and appreciate the wide range of potential presentations. Differentiating idiopathic VT, such as RVOT-VT, from more malignant forms of VT can be challenging and requires expert consultation for further diagnostic workup and management.

Is pelvic ultrasound associated with an increased time to appendectomy in pediatric appendicitis?

BACKGROUND: Appendicitis is a common pediatric condition requiring urgent surgical intervention to prevent complications. Pelvic ultrasound (US) as a diagnostic aid has become increasingly common. Despite its advantages, evidence suggests US can lead to delayed definitive management. OBJECTIVE: The objective was to test the hypothesis that US is associated with an increased time to appendectomy in children with acute appendicitis. METHODS: A chart review was conducted of all children aged 0-17 years who presented to the pediatric emergency department (ED) with a discharge diagnosis of appendicitis. The primary outcome variable was the interval between initial evaluation to appendectomy between patients who received an US and those who did not. RESULTS: Of 662 cases included, 424 patients (64%) underwent a pelvic US and 238 patients underwent an appendectomy without US. Median time interval from initial evaluation in the ED by a physician to appendectomy among patients who received an US was 9.7 h (interquartile range [IQR]: 6.8-15.0 h) compared with 5.5 h (IQR: 3.8-8.6 h) among patients who did not receive an US (Mann-Whitney, p < 0.001). The increased time to appendectomy in patients who received an US was dependent on the patient being female and presenting to the ED after hours (univariate analysis of variance test for interaction, p < 0.05). CONCLUSIONS: Female pediatric patients and those presenting after hours that undergo an US have a significantly increased time to appendectomy compared with those who do not undergo diagnostic imaging.

Performance of the Canadian Triage and Acuity Scale for children: a multicenter database study.

STUDY OBJECTIVE: We evaluate the association between triage levels assigned using the Canadian Triage and Acuity Scale and surrogate markers of validity for real-life children triaged in multiple emergency departments (EDs). METHODS: This was a retrospective cohort study evaluating the triage assessment and outcomes of all children presenting to 12 pediatric EDs, all of which are members of the Pediatric Emergency Research Canada group, during a 1-year period (2010 to 2011). Anonymous data were retrieved from the ED computerized databases. The primary outcome measure was the proportion of children hospitalized for each triage level. Other outcomes were ICU admission, proportion of patients who left without being seen by a physician, and length of stay in the ED. Evaluation of all children visiting these EDs during 1 year was expected to provide more than 1,000 patients in each triage category. RESULTS: A total of 550,940 children were included. Pooled data demonstrated hospitalization proportions of 61%, 30%, 10%, 2%, and 0.9% for patients in Canadian Triage and Acuity Scale levels 1, 2, 3, 4, and 5, respectively. There was a strong association between triage level and admission to the ICU, probability of leaving without being seen by a physician, and length of stay. CONCLUSION: The strong association between triage level and multiple markers of severity in 12 Canadian pediatric EDs suggests validity of the Canadian Triage and Acuity Scale for children.

Epinephrine and dexamethasone in children with bronchiolitis.

BACKGROUND: Although numerous studies have explored the benefit of using nebulized epinephrine or corticosteroids alone to treat infants with bronchiolitis, the effectiveness of combining these medications is not well established. METHODS: We conducted a multicenter, double-blind, placebo-controlled trial in which 800 infants (6 weeks to 12 months of age) with bronchiolitis who were seen in the pediatric emergency department were randomly assigned to one of four study groups. One group received two treatments of nebulized epinephrine (3 ml of epinephrine in a 1:1000 solution per treatment) and a total of six oral doses of dexamethasone (1.0 mg per kilogram of body weight in the emergency department and 0.6 mg per kilogram for an additional 5 days) (the epinephrine-dexamethasone group), the second group received nebulized epinephrine and oral placebo (the epinephrine group), the third received nebulized placebo and oral dexamethasone (the dexamethasone group), and the fourth received nebulized placebo and oral placebo (the placebo group). The primary outcome was hospital admission within 7 days after the day of enrollment (the initial visit to the emergency department). RESULTS: Baseline clinical characteristics were similar among the four groups. By the seventh day, 34 infants (17.1%) in the epinephrine-dexamethasone group, 47 (23.7%) in the epinephrine group, 51 (25.6%) in the dexamethasone group, and 53 (26.4%) in the placebo group had been admitted to the hospital. In the unadjusted analysis, only the infants in the epinephrine-dexamethasone group were significantly less likely than those in the placebo group to be admitted by day 7 (relative risk, 0.65; 95% confidence interval, 0.45 to 0.95, P=0.02). However, with adjustment for multiple comparisons, this result was rendered insignificant (P=0.07). There were no serious adverse events. CONCLUSIONS: Among infants with bronchiolitis treated in the emergency department, combined therapy with dexamethasone and epinephrine may significantly reduce hospital admissions. (Current Controlled Trials number, ISRCTN56745572.)

The Canadian Triage and Acuity Scale for children: a prospective multicenter evaluation.

STUDY OBJECTIVE: The aims of the study are to measure both the interrater agreement of nurses using the Canadian Triage and Acuity Scale in children and the validity of the scale as measured by the correlation between triage level and proxy markers of severity. METHODS: This was a prospective multicenter study of the reliability and construct validity of the Canadian Triage and Acuity Scale in 9 tertiary care pediatric emergency departments (EDs) across Canada during 2009 to 2010. Participants were a sample of children initially triaged as Canadian Triage and Acuity Scale level 2 (emergency) to level 5 (nonurgent). Participants were recruited immediately after their initial triage to undergo a second triage assessment by the research nurse. Both triages were performed blinded to the other. The primary outcome measures were the interrater agreement between the 2 nurses and the association between triage level and hospitalization. Secondary outcome measures were the association between triage level and health resource use and length of stay in the ED. RESULTS: A total of 1,564 patients were approached and 1,464 consented. The overall interrater agreement was good, as demonstrated by a quadratic weighted κ score of 0.74 (95% confidence interval 0.71 to 0.76). Hospitalization proportions were 30%, 8.3%, 2.3%, and 2.2% for patients triaged at levels 2, 3, 4, and 5, respectively. There was also a strong association between triage levels and use of health care resources and length of stay. CONCLUSION: The Canadian Triage and Acuity Scale demonstrates a good interrater agreement between nurses across multiple pediatric EDs and is a valid triage tool, as demonstrated by its good association with markers of severity.

Developing measures of quality for the emergency department management of pediatric suicide-related behaviors.

OBJECTIVE: Given the public health importance of suicide-related behaviors and the corresponding gap in the performance measurement literature, we sought to identify key candidate process indicators (quality of care measures) and structural measures (organizational resources and attributes) important for emergency department (ED) management of pediatric suicide-related behaviors. METHODS: We reviewed nationally endorsed guidelines and published research to establish an inventory of measures. Next, we surveyed expert pediatric ED clinicians to assess the level of agreement on the relevance (to patient care) and variability (across hospitals) of 42 candidate process indicators and whether 10 hospital and regional structural measures might impact these processes. RESULTS: Twenty-three clinicians from 14 pediatric tertiary-care hospitals responded (93% of hospitals contacted). Candidate process indicators identified as both most relevant to patient care (≥87% agreed or strongly agreed) and most variable across hospitals (≥78% agreed or strongly agreed) were wait time for medical assessment; referral to crisis intervention worker/program; mental health, psychosocial, or risk assessment requested; any inpatient admission; psychiatric inpatient admission; postdischarge treatment plan; wait time for first follow-up appointment; follow-up obtained; and type of follow-up obtained. Key hospital and regional structural measures (≥87% agreed or strongly agreed) were specialist staffing and type of specialist staffing in or available to the ED; regional policies, protocols, or procedures; and inpatient psychiatric services. CONCLUSIONS: This study highlighted candidate performance measures for the ED management of pediatric suicide-related behaviors. The 9 candidate process indicators (covering triage, assessment, admission, discharge, and follow-up) and 4 hospital and regional structural measures merit further development.

How safe are paediatric emergency departments? A national prospective cohort study.

BACKGROUND: Despite the high number of children treated in emergency departments, patient safety risks in this setting are not well quantified. Our objective was to estimate the risk and type of adverse events, as well as their preventability and severity, for children treated in a paediatric emergency department. METHODS: Our prospective, multicentre cohort study enrolled children presenting for care during one of 168 8-hour study shifts across nine paediatric emergency departments. Our primary outcome was an adverse event within 21 days of enrolment which was related to care provided at the enrolment visit. We identified 'flagged outcomes' (such as hospital visits, worsening symptoms) through structured telephone interviews with patients and families over the 21 days following enrolment. We screened admitted patients' health records with a validated trigger tool. For patients with flags or triggers, three reviewers independently determined whether an adverse event occurred. RESULTS: We enrolled 6376 children; 6015 (94%) had follow-up data. Enrolled children had a median age of 4.3 years (IQR 1.6-9.8 years). One hundred and seventy-nine children (3.0%, 95% CI 2.6% to 3.5%) had at least one adverse event. There were 187 adverse events in total; 143 (76.5%, 95% CI 68.9% to 82.7%) were deemed preventable. Management (n=98, 52.4%) and diagnostic issues (n=36, 19.3%) were the most common types of adverse events. Seventy-nine (42.2%) events resulted in a return emergency department visit; 24 (12.8%) resulted in hospital admission; and 3 (1.6%) resulted in transfer to a critical care unit. CONCLUSION: In this large-scale study, 1 in 33 children treated in a paediatric emergency department experienced an adverse event related to the care they received there. The majority of events were preventable; most were related to management and diagnostic issues. Specific patient populations were at higher risk of adverse events. We identify opportunities for improvement in care.

An Innovative Model of Pediatric Emergency Department Mental Health Care: Protocol for a Multicenter Type 1 Effectiveness-Implementation Cluster Randomized Trial.

Over the past decade, visits to American and Canadian emergency departments (EDs) for child and youth mental health care have increased substantially.1,2 Acute mental health crises can occur as a result of a variety of concerns, including those that are life threatening (eg, suicide attempts), pose safety concerns (eg, suicidal intentions, aggressive behaviors, alcohol and other drug use), and are physically distressing to the child or youth (eg, panic attacks). ED health care providers play a vital role in assessing the safety and well-being of the child or youth and referring them to services for ongoing care.3,4 During the ED visit, assessment and care should pinpoint risks, inform treatment, and consider family needs and preferences as part of a patient-centered approach. Yet, this approach to care is not widely adopted in EDs. Most EDs do not require the use of pediatric-specific mental health tools to guide assessments or have patient-centered procedures in place to guide the care of patients with mental health emergencies.5-7 Our team believes these limitations have led to the provision of acute mental health care that can lack sufficient quality and efficiency. This study protocol describes a trial designed to evaluate if a novel mental health care bundle that was co-designed with parents and youth results in greater improvements in the well-being of children and youth 30 days after seeking ED care for mental health and/or substance misuse concerns compared with existing care protocols. We hypothesize that the bundle will positively impact child and youth well-being, while also providing cost-effective health care system benefits.

Risk of asthma in children diagnosed with bronchiolitis during infancy: protocol of a longitudinal cohort study linking emergency department-based clinical data to provincial health administrative databases.

INTRODUCTION: The Canadian Bronchiolitis Epinephrine Steroid Trial (CanBEST) and the Bronchiolitis Severity Cohort (BSC) study enrolled infants with bronchiolitis during the first year of life. The CanBEST trial suggested that treatment of infants with a combined therapy of high-dose corticosteroids and nebulised epinephrine reduced the risk of admission to hospital. Our study aims to-(1) quantify the risk of developing asthma by age 5 and 10 years in children treated with high-dose corticosteroid and epinephrine for bronchiolitis during infancy, (2) identify risk factors associated with development of asthma in children with bronchiolitis during infancy, (3) develop asthma prediction models for children diagnosed with bronchiolitis during infancy. METHODS AND ANALYSIS: We propose a longitudinal cohort study in which we will link data from the CanBEST and BSC study with routinely collected data from provincial health administrative databases. Our outcome is asthma incidence measured using a validated health administrative data algorithm. Primary exposure will be treatment with a combined therapy of high-dose corticosteroids and nebulised epinephrine for bronchiolitis. Covariates will include type of viral pathogen, disease severity, medication use, maternal, prenatal, postnatal and demographic factors and variables related to health service utilisation for acute lower respiratory tract infection. The risk associated with development of asthma in children treated with high-dose corticosteroid and epinephrine for bronchiolitis will be assessed using multivariable Cox proportional hazards regression models. Prediction models will be developed using multivariable logistic regression analysis and internally validated using a bootstrap approach. ETHICS AND DISSEMINATION: Our study has been approved by the ethics board of all four participating sites of the CanBEST and BSC study. Finding of the study will be disseminated to the academic community and relevant stakeholders through conferences and peer-reviewed publications. TRIAL REGISTRATION NUMBER: ISRCTN56745572; Post-results.

CATCH: a clinical decision rule for the use of computed tomography in children with minor head injury.

BACKGROUND: There is controversy about which children with minor head injury need to undergo computed tomography (CT). We aimed to develop a highly sensitive clinical decision rule for the use of CT in children with minor head injury. METHODS: For this multicentre cohort study, we enrolled consecutive children with blunt head trauma presenting with a score of 13-15 on the Glasgow Coma Scale and loss of consciousness, amnesia, disorientation, persistent vomiting or irritability. For each child, staff in the emergency department completed a standardized assessment form before any CT. The main outcomes were need for neurologic intervention and presence of brain injury as determined by CT. We developed a decision rule by using recursive partitioning to combine variables that were both reliable and strongly associated with the outcome measures and thus to find the best combinations of predictor variables that were highly sensitive for detecting the outcome measures with maximal specificity. RESULTS: Among the 3866 patients enrolled (mean age 9.2 years), 95 (2.5%) had a score of 13 on the Glasgow Coma Scale, 282 (7.3%) had a score of 14, and 3489 (90.2%) had a score of 15. CT revealed that 159 (4.1%) had a brain injury, and 24 (0.6%) underwent neurologic intervention. We derived a decision rule for CT of the head consisting of four high-risk factors (failure to reach score of 15 on the Glasgow coma scale within two hours, suspicion of open skull fracture, worsening headache and irritability) and three additional medium-risk factors (large, boggy hematoma of the scalp; signs of basal skull fracture; dangerous mechanism of injury). The high-risk factors were 100.0% sensitive (95% CI 86.2%-100.0%) for predicting the need for neurologic intervention and would require that 30.2% of patients undergo CT. The medium-risk factors resulted in 98.1% sensitivity (95% CI 94.6%-99.4%) for the prediction of brain injury by CT and would require that 52.0% of patients undergo CT. INTERPRETATION: The decision rule developed in this study identifies children at two levels of risk. Once the decision rule has been prospectively validated, it has the potential to standardize and improve the use of CT for children with minor head injury.

A pragmatic randomized controlled trial of multi-dose oral ondansetron for pediatric gastroenteritis (the DOSE-AGE study): statistical analysis plan.

BACKGROUND: Acute gastroenteritis is a leading cause of emergency department visits and hospitalizations among children in North America. Oral-rehydration therapy is recommended for children with mild-to-moderate dehydration, but children who present with vomiting are frequently offered intravenous rehydration in the emergency department (ED). Recent studies have demonstrated that the anti-emetic ondansetron can reduce vomiting, intravenous rehydration, and hospitalization when administered in the ED to children with dehydration. However, there is little evidence of additional benefit from prescribing ondansetron beyond the initial ED dose. Moreover, repeat dosing may increase the frequency of diarrhea. Despite the lack of evidence and potential adverse side effects, many physicians across North America provide multiple doses of ondansetron to be taken following ED disposition. Thus, the Multi-Dose Oral Ondansetron for Pediatric Gastroenteritis (DOSE-AGE) trial will evaluate the effectiveness of prescribing multiple doses of ondansetron to treat acute gastroenteritis-associated vomiting. This article specifies the statistical analysis plan (SAP) for the DOSE-AGE trial and was submitted before the outcomes of the study were available for analysis. METHODS/DESIGN: The DOSE-AGE study is a phase III, 6-center, placebo-controlled, double-blind, parallel design randomized controlled trial designed to determine whether participants who are prescribed multiple doses of oral ondansetron to administer, as needed, following their ED visit have a lower incidence of experiencing moderate-to-severe gastroenteritis, as measured by the Modified Vesikari Scale score, compared with a placebo. To assess safety, the DOSE-AGE trial will investigate the frequency and maximum number of diarrheal episodes following ED disposition, and the occurrence of palpitations, pre-syncope/syncope, chest pain, arrhythmias, and serious adverse events. For the secondary outcomes, the DOSE-AGE trial will investigate the individual elements of the Modified Vesikari Scale score and caregiver satisfaction with the therapy. DISCUSSION: The DOSE-AGE trial will provide evidence on the effectiveness of multiple doses of oral ondansetron, taken as needed, following an initial ED dose in children with acute gastroenteritis-associated vomiting. The data from the DOSE-AGE trial will be analyzed using this SAP. This will reduce the risk of producing data-driven results and bias in our reported outcomes. The DOSE-AGE study was registered on ClinicalTrials.gov on February 22, 2019. TRIAL REGISTRATION: ClinicalTrials.gov NCT03851835 . Registered on 22 February 2019.

Multi-dose Oral Ondansetron for Pediatric Gastroenteritis: study Protocol for the multi-DOSE oral ondansetron for pediatric Acute GastroEnteritis (DOSE-AGE) pragmatic randomized controlled trial.

BACKGROUND: There are limited treatment options that clinicians can provide to children presenting to emergency departments with vomiting secondary to acute gastroenteritis. Based on evidence of effectiveness and safety, clinicians now routinely administer ondansetron in the emergency department to promote oral rehydration therapy success. However, clinicians are also increasingly providing multiple doses of ondansetron for home use, creating unquantified cost and health system resource use implications without any evidence to support this expanding practice. METHODS/DESIGN: DOSE-AGE is a randomized, placebo-controlled, double-blinded, six-center, pragmatic clinical trial being conducted in six Canadian pediatric emergency departments (EDs). In September 2019 the study began recruiting children aged 6 months to 18 years with a minimum of three episodes of vomiting in the 24 h preceding enrollment, <72 h of gastroenteritis symptoms and who were administered a dose of ondansetron during their ED visit. We are recruiting 1030 children (1:1 allocation via an internet-based, third-party, randomization service) to receive a 48-h supply (i.e., six doses) of ondansetron oral solution or placebo, administered on an as-needed basis. All participants, caregivers and outcome assessors will be blinded to group assignment. Outcome data will be collected by surveys administered to caregivers 24, 48 and 168 h following enrollment. The primary outcome is the development of moderate-to-severe gastroenteritis in the 7 days following the ED visit as measured by a validated clinical score (the Modified Vesikari Scale). Secondary outcomes include duration and frequency of vomiting and diarrhea, proportions of children experiencing unscheduled health care visits and intravenous rehydration, caregiver satisfaction with treatment and safety. A preplanned economic evaluation will be conducted alongside the trial. DISCUSSION: Definitive data are lacking to guide the clinical use of post-ED visit multidose ondansetron in children with acute gastroenteritis. Usage is increasing, despite the absence of supportive evidence. The incumbent additional costs associated with use, and potential side effects such as diarrhea and repeat visits, create an urgent need to evaluate the effect and safety of multiple doses of ondansetron in children focusing on post-emergency department visit and patient-centered outcomes. TRIAL REGISTRATION: ClinicalTrials.gov: NCT03851835. Registered on 22 February 2019.

Intranasal Dexmedetomidine for Procedural Distress in Children: A Systematic Review.

CONTEXT: Intranasal dexmedetomidine (IND) is an emerging agent for procedural distress in children. OBJECTIVE: To explore the effectiveness of IND for procedural distress in children. DATA SOURCES: We performed electronic searches of Medline (1946-2019), Embase (1980-2019), Google Scholar (2019), Cumulative Index to Nursing and Allied Health Literature (1981-2019), and Cochrane Central Register. STUDY SELECTION: We included randomized trials of IND for procedures in children. DATA EXTRACTION: Methodologic quality of evidence was evaluated by using the Cochrane Collaboration's risk of bias tool and the Grading of Recommendations Assessment, Development, and Evaluation system, respectively. The primary outcome was the proportion of participants with adequate sedation. RESULTS: Among 19 trials (N = 2137), IND was superior to oral chloral hydrate (3 trials), oral midazolam (1 trial), intranasal midazolam (1 trial), and oral dexmedetomidine (1 trial). IND was equivalent to oral chloral hydrate (2 trials), intranasal midazolam (2 trials), and intranasal ketamine (3 trials). IND was inferior to oral ketamine and a combination of IND plus oral ketamine (1 trial). Higher doses of IND were superior to lower doses (4 trials). Adverse effects were reported in 67 of 727 (9.2%) participants in the IND versus 98 of 591 (16.6%) in the comparator group. There were no reports of adverse events requiring resuscitative measures. LIMITATIONS: The adequacy of sedation was subjective, which possibly led to biased outcome reporting. CONCLUSIONS: Given the methodologic limitations of included trials, IND is likely more effective at sedating children compared to oral chloral hydrate and oral midazolam. However, this must be weighed against the potential for adverse cardiovascular effects.

Additive value of nuclear medicine shuntograms to computed tomography for suspected cerebrospinal fluid shunt obstruction in the pediatric emergency department.

OBJECTIVE: To measure the predictive value of nuclear medicine studies (cerebrospinal fluid [CSF] shuntograms) and radiographic studies (computed tomographic [CT] scans) in a cohort of children undergoing evaluation for suspected shunt obstruction in a tertiary care pediatric emergency department (ED). METHODS: A retrospective chart review was conducted on patients younger than 18 years who presented to the pediatric ED of the Children's Hospital of Western Ontario and had both CT of the head and a CSF shuntogram ordered by the attending pediatric emergency medicine physician between December 1998 and April 2003 because of suspected shunt obstruction. RESULTS: A total of 69 patients were evaluated for suspected shunt obstruction in the ED during this period with both a CT and a CSF shuntogram. Twenty-seven patients (39.1%) subsequently required corrective surgery for suspected shunt obstruction that was confirmed intraoperatively. The CT scans showed abnormalities suggestive of CSF shunt obstruction in 21 of the patients who required surgery (sensitivity, 77.8%; negative predictive value, 82.4%), whereas the CSF shuntograms showed abnormalities suggestive of CSF obstruction in 25 of the patients who required surgery (sensitivity, 92.6%; negative predictive value, 92.6%). The CT scans and the shuntograms combined revealed abnormalities suggestive of CSF shunt obstruction in 26 of the 27 patients who required surgery (sensitivity, 96.3%; negative predictive value, 97.4%). CONCLUSIONS: Over one third of pediatric ED patients evaluated with CT and CSF shuntograms required surgical management. Sensitivity was increased with CT and CSF shuntogram compared with CT alone. Prospective studies are required to assess the use of radiographic and nuclear medicine tests for the shunt evaluation in conjunction with the development of a clinical prediction rule for the pediatric emergency physician.

A needs assessment for obesity-related anticipatory guidance in the paediatric emergency department.

BACKGROUND: The prevalence of Canadian childhood obesity has been increasing, resulting in a call for improved prevention efforts and anticipatory guidance. OBJECTIVE: To evaluate interest in obesity-related anticipatory guidance in a paediatric emergency department. METHODS: Between September 2005 and September 2006, parents or patients older than 14 years of age were approached at the emergency department of the Children's Hospital (London, Ontario) to complete a survey. The survey compiled demographic data and asked questions regarding self-perceived weight status, use of dieting and/or exercise for weight loss, desire for nutrition and/or exercise information, and interest in receiving anticipatory guidance related to obesity. RESULTS: Two hundred people completed the survey; the vast majority (92%) of respondents were parents. The mean (+/- SD) age of the children was 12.6+/-3.9 years. Forty-one per cent of the respondents indicated an interest in further information on obesity (95% CI 34% to 48%). Fifty-two per cent of respondents considered themselves overweight or obese (95% CI 45% to 59%), and 52% reported someone in their family who was dieting, exercising or both to lose weight. Parents who stated that their children considered themselves to be overweight or obese were significantly less interested in anticipatory guidance than parents who did not believe that their children considered themselves to be overweight or obese (67% versus 90%, respectively; P=0.009). DISCUSSION: Many patients in the paediatric emergency department desire information on nutrition and exercise. Further research into risk-stratified targeting of patients and parents are needed to help identify good candidates for anticipatory guidance.