QuestionAmong children discharged from the emergency department (ED) with vomiting due to acute gastroenteritis, which patient characteristics are associated with persistent vomiting?FindingsIn this secondary analysis of a randomized clinical trial, among 977 children, those aged 6 months to less than 2 years, those with a short duration of vomiting and/or diarrhea, and those with 10 episodes or more of vomiting during the 24 hours preceding ED presentation were statistically significantly more likely to have 3 or more episodes of postdischarge vomiting in a 24-hour period, as well as greater health care utilization.MeaningThese findings suggest that young children and those early in their illness with significant vomiting are most likely to experience ongoing vomiting after ED discharge and to utilize health care resources. ImportanceChildren with acute gastroenteritis-associated vomiting discharged from emergency departments (EDs) have improved outcomes when provided with ondansetron for home use. However, only one-third of children who present with significant vomiting experience ongoing vomiting after discharge.ObjectiveTo identify characteristics associated with 3 or more vomiting episodes among pediatric patients within 24 hours of ED discharge.Design, Setting, and ParticipantsThis nonprespecified secondary analysis of a randomized clinical trial of children aged 6 months to less than 18 years presenting to EDs between September 14, 2019, and June 27, 2024, with acute gastroenteritis-associated vomiting and who were followed up for 7 days. A prognostic score was derived using generalized linear mixed models across 10 imputed datasets. Data analysis was performed between May 9, 2025, and February 13, 2026.Main Outcomes and MeasuresThe primary outcome was 3 or more episodes of vomiting within 24 hours of ED discharge. Secondary outcomes included unscheduled health care revisits, intravenous fluid administration, and hospitalization within 7 days after the ED visit.ResultsOf 1030 children enrolled, 977 had follow-up data available and were included in this analysis (median age, 47.0 months [IQR, 22.1-80.1 months]; 493 [50.5%] girls; 925 [89.8%] with complete follow-up data). Eighty of 927 children (8.6%) had 3 or more episodes of vomiting in the 24 hours after ED discharge. In unadjusted analysis, only age 6 months to less than 2 years was associated with ongoing vomiting after discharge (odds ratio [OR], 2.17; 95% CI, 1.37-3.43). In multivariable regression analysis, variables associated with postdischarge vomiting included age 6 months to less than 2 years, symptom duration of 24 to 48 hours, or 10 or more vomiting episodes in the 24 hours preceding the ED visit. In a predictive model, a score of 4 points or more was associated with a 13.6% (95% CI, 9.9%-18.1%) probability of 3 or more vomiting episodes within 24 hours of ED discharge, with a sensitivity of 0.50 (95% CI, 0.39-0.61) and specificity of 0.70 (95% CI, 0.67-0.73). Children with 3 or more vomiting episodes within 24 hours of discharge, compared with those without, were more likely to have an unscheduled health care visit (33 of 80 [41.3%] vs 65 of 846 [7.7%]; difference, 33.6%; 95% CI, 22.6%-44.5%), receive intravenous fluids (9 of 80 [11.3%] vs 15 of 846 [1.8%]; difference, 9.5%; 95% CI, 2.5%-16.5%), and be hospitalized (5 of 80 [6.2%] vs 9 of 846 [1.1%]; difference, 5.2%; 95% CI, -0.2% to 10.5%) within 7 days of discharge.Conclusions and RelevanceIn this analysis of children presenting for ED care with vomiting, younger children and those unwell for 24 to 48 hours with 10 or more episodes of vomiting at presentation were more likely to have persistent vomiting after discharge. Based on these findings, these children are most likely to benefit from being provided ondansetron for home administration.Trial RegistrationClinicalTrials.gov Identifier: NCT03851835 This secondary analysis of a randomized clinical trial examines independent risk factors associated with ongoing vomiting among pediatric patients within 24 hours of ED discharge.
Importance:Children with acute gastroenteritis-associated vomiting discharged from emergency departments (EDs) have improved outcomes when provided with ondansetron for home use. However, only one-third of children who present with significant vomiting experience ongoing vomiting after discharge. Objective:To identify characteristics associated with 3 or more vomiting episodes among pediatric patients within 24 hours of ED discharge. Design, Setting, and Participants:This nonprespecified secondary analysis of a randomized clinical trial of children aged 6 months to less than 18 years presenting to EDs between September 14, 2019, and June 27, 2024, with acute gastroenteritis-associated vomiting and who were followed up for 7 days. A prognostic score was derived using generalized linear mixed models across 10 imputed datasets. Data analysis was performed between May 9, 2025, and February 13, 2026. Main Outcomes and Measures:The primary outcome was 3 or more episodes of vomiting within 24 hours of ED discharge. Secondary outcomes included unscheduled health care revisits, intravenous fluid administration, and hospitalization within 7 days after the ED visit. Results:Of 1030 children enrolled, 977 had follow-up data available and were included in this analysis (median age, 47.0 months [IQR, 22.1-80.1 months]; 493 [50.5%] girls; 925 [89.8%] with complete follow-up data). Eighty of 927 children (8.6%) had 3 or more episodes of vomiting in the 24 hours after ED discharge. In unadjusted analysis, only age 6 months to less than 2 years was associated with ongoing vomiting after discharge (odds ratio [OR], 2.17; 95% CI, 1.37-3.43). In multivariable regression analysis, variables associated with postdischarge vomiting included age 6 months to less than 2 years, symptom duration of 24 to 48 hours, or 10 or more vomiting episodes in the 24 hours preceding the ED visit. In a predictive model, a score of 4 points or more was associated with a 13.6% (95% CI, 9.9%-18.1%) probability of 3 or more vomiting episodes within 24 hours of ED discharge, with a sensitivity of 0.50 (95% CI, 0.39-0.61) and specificity of 0.70 (95% CI, 0.67-0.73). Children with 3 or more vomiting episodes within 24 hours of discharge, compared with those without, were more likely to have an unscheduled health care visit (33 of 80 [41.3%] vs 65 of 846 [7.7%]; difference, 33.6%; 95% CI, 22.6%-44.5%), receive intravenous fluids (9 of 80 [11.3%] vs 15 of 846 [1.8%]; difference, 9.5%; 95% CI, 2.5%-16.5%), and be hospitalized (5 of 80 [6.2%] vs 9 of 846 [1.1%]; difference, 5.2%; 95% CI, -0.2% to 10.5%) within 7 days of discharge. Conclusions and Relevance:In this analysis of children presenting for ED care with vomiting, younger children and those unwell for 24 to 48 hours with 10 or more episodes of vomiting at presentation were more likely to have persistent vomiting after discharge. Based on these findings, these children are most likely to benefit from being provided ondansetron for home administration. Trial Registration:ClinicalTrials.gov Identifier: NCT03851835.
BACKGROUND:Bronchiolitis exerts a high burden on children, their families and the healthcare system. The Canadian Bronchiolitis Epinephrine Steroid Trial (CanBEST) assessed whether administering epinephrine alone, dexamethasone alone, or in combination (EpiDex) could reduce bronchiolitis-related hospitalizations among children less than 12 months of age compared to placebo. CanBEST demonstrated a statistically significant reduction in 7-day hospitalization risk with EpiDex in an unadjusted analysis but not after adjustment. OBJECTIVE:To explore the probability that EpiDex results in a reduction in hospitalizations using Bayesian methods. STUDY DESIGN:Using prior distributions that represent varying levels of preexisting enthusiasm or skepticism, i.e., how confident or doubtful one is that EpiDex may reduce hospitalizations, and information about the treatment effect before data were collected, the posterior distribution of the relative risk of hospitalization compared to placebo was determined. The probability that the treatment effect is less than 1, 0.9, 0.8 and 0.6, indicating increasing reductions in hospitalization risk, are computed alongside 95% credible intervals. RESULTS:Combining a minimally informative prior distribution with the data from CanBEST provides comparable results to the original analysis. Unless strongly skeptical views about the effectiveness of EpiDex were considered, the 95% credible interval for the treatment effect lies below 1, indicating a reduction in hospitalizations. There is a 90% probability that EpiDex results in a clinically meaningful reduction in hospitalization of 10% even when incorporating skeptical views, with a 67% probability when considering strongly skeptical views. CONCLUSION:A Bayesian analysis demonstrates a high chance that EpiDex reduces hospitalization rates for bronchiolitis, although strongly skeptical individuals may require additional evidence to change practice. TRIAL REGISTRATION:Clinical Trial registry name, registration number: Current Controlled Trials number, ISRCTN56745572.
Abstract Background Emergency medical care inherently carries a potential for adverse events. With the increase in virtual medical care due to its ease of access and ability to limit the spread of infection, there is a need to evaluate the safety of paediatric emergency medicine virtual clinics. Objectives To elucidate the frequency of adverse events occurring within 7 days of accessing medical care provided by a Paediatric Emergency Medicine Virtual Clinic. We then seek to characterize the severity, nature, and preventability of the adverse events and to provide a knowledge base for future work related to patient safety in the virtual emergency care domain. Design/Methods This study was a prospective cohort study where the primary outcome was the proportion of patients who experienced an adverse event within 7 days of accessing care through a virtual emergency clinic. Data was collected through telephone interviews and chart analysis with the use of a validated adverse events trigger tool to determine which charts required independent physician review. The final data was categorized using descriptive statistics, and logistic regression analysis was conducted to examine potential predictors of adverse events. Results Of 593 eligible families, 232 (39%) consented to participate and completed the interview process. Of these families, 89 were flagged for further review, and subsequent analysis concluded that 5 (2.2%) had experienced an adverse event. Of the adverse events, 4 (80%) were considered preventable and the most common type of adverse event was sub-optimal follow up (60%). The median patient age was 3.0 years (IQR 1.0-5.0). There were no clinically significant differences between the patients who experienced an adverse event and those that did not across the parameters studied (age, sex, gender, medical complexity, length of symptoms, language of fluency, and self-identification of visible minority status). Conclusion 2.2% of patients, approximately 1 in 45, experienced adverse events related to the care they received at the virtual clinic. The majority of these adverse events were preventable. That said, the rates of events were within the published norm, suggesting the virtual clinic provides a viable option in paediatric emergency medicine.
BACKGROUND:Ondansetron improves outcomes when administered in emergency departments to children with acute gastroenteritis-associated vomiting. It is commonly prescribed at discharge to reduce symptoms, but evidence to support this practice is limited. METHODS:We conducted a double-blind, randomized superiority trial involving children 6 months to less than 18 years of age with acute gastroenteritis-associated vomiting in six pediatric emergency departments. Caregivers were provided with six doses of oral ondansetron or placebo to administer in response to ongoing vomiting during the first 48 hours after enrollment. The primary outcome was moderate-to-severe gastroenteritis, defined by a score of 9 or higher on the modified Vesikari scale (scores range from 0 to 20, with higher scores indicating greater severity), during the 7 days after enrollment. Secondary outcomes included the presence of vomiting, the duration of vomiting (defined as the time from enrollment to the last vomiting episode), the number of vomiting episodes within 48 hours after enrollment, unscheduled physician visits within 7 days after enrollment, and receipt of intravenous fluids. RESULTS:A total of 1030 children underwent randomization. Moderate-to-severe gastroenteritis occurred in 5.1% (23 of 452 participants for whom data were available) in the ondansetron group and 12.5% (55 of 441) in the placebo group (unadjusted risk difference, -7.4 percentage points; 95% confidence interval [CI], -11.2 to -3.7). After adjustment for site, weight, and missing data, ondansetron was associated with a lower risk of moderate-to-severe gastroenteritis than placebo (adjusted odds ratio, 0.50; 95% CI, 0.40 to 0.60). Although we did not observe any meaningful difference between the groups in the presence or median duration of vomiting, the total number of vomiting episodes within 48 hours after enrollment was lower with ondansetron than with placebo (adjusted rate ratio, 0.76; 95% CI, 0.67 to 0.87). The percentage of children who had unscheduled health care visits and the percentage who received intravenous fluids after enrollment did not differ substantially between the groups. The incidence of adverse events also did not differ meaningfully between the groups (odds ratio, 0.99; 95% CI, 0.61 to 1.61). CONCLUSIONS:Among children with gastroenteritis-associated vomiting, the provision of ondansetron after an emergency department visit led to lower risk of moderate-to-severe gastroenteritis during the subsequent 7 days than the provision of placebo. (Funded by the Canadian Institutes of Health Research and others; ClinicalTrials.gov number, NCT03851835.).
Introduction:Bronchiolitis exerts a significant burden of illness on infants worldwide. National guidelines advise only supportive care. There is evidence that treating infants with bronchiolitis with a combination of inhaled epinephrine and dexamethasone may reduce hospital admissions. Objective:The aim of this study is to determine if infants with bronchiolitis treated with inhaled epinephrine (delivered by metered dose inhaler with spacer or nebuliser) in the emergency department and a 2-day course of oral dexamethasone have fewer hospitalisations compared to infants treated with placebo. Methods:The BIPED study (Bronchiolitis in Infants Placebo versus Epinephrine and Dexamethasone) is a randomised, placebo-controlled, observer, investigator, clinician and patient blinded superiority clinical trial being conducted in 12 emergency departments across three countries (Canada, New Zealand and Australia). We will recruit 864 infants between 60 days and 12 months of age with bronchiolitis to receive either: 1) two inhaled epinephrine treatments (3 mg via nebuliser or 625 µg via metered dose inhaler with spacer) 30 min apart and a simultaneous dose of oral dexamethasone (0.6 mg·kg-1, maximum 10 mg) in the emergency department with the dexamethasone repeated at 24 h; or 2) inhaled placebo and oral placebo. The primary outcome is hospital admission for bronchiolitis within 7 days (168 h) of enrolment. Secondary outcomes include hospital admission during enrolment and all-cause hospital admissions within 21 days of enrolment. Conclusion:Given the burden of bronchiolitis, there is urgent need for a trial to confirm if combination therapy with epinephrine and dexamethasone is effective.
Background Bronchiolitis exerts a high burden on children, their families and the healthcare system. The Canadian Bronchiolitis Epinephrine Steroid Trial (CanBEST) assessed whether administering epinephrine alone, dexamethasone alone, or in combination (EpiDex) could reduce bronchiolitis-related hospitalizations among children less than 12 months of age compared to placebo. CanBEST demonstrated a statistically significant reduction in 7-day hospitalization risk with EpiDex in an unadjusted analysis but not after adjustment. Objective To explore the probability that EpiDex results in a reduction in hospitalizations using Bayesian methods. Study Design Using prior distributions that represent varying levels of preexisting enthusiasm or skepticism and information about the treatment effect before data were collected, the Bayesian distribution of the relative risk of hospitalization compared to placebo was determined. The probability that the treatment effect is less 1, 0.9, 0.8 and 0.6, indicating increasing reductions in hospitalization risk, are computed alongside 95% credible intervals. Results Combining a minimally informative prior distribution with the data from CanBEST provides comparable results to the original analysis. Unless strongly skeptical views about the effectiveness of EpiDex were considered, the 95% credible interval for the treatment effect lies below 1, indicating a reduction in hospitalizations. There is a 90% probability that EpiDex results in a clinically meaningful reduction in hospitalization of 10% even when incorporating skeptical views, with a 67% probability when considering strongly skeptical views. Conclusion A Bayesian analysis demonstrates a high chance that EpiDex reduces hospitalization rates for bronchiolitis, although strongly skeptical individuals may require additional evidence to change practice. ### Competing Interest Statement Amy C. Plint receives in-kind support from Amphastar for a clinical trial in bronchiolitis. The other authors have no relevant conflicts to disclose. ### Clinical Trial Current Controlled Trials number, ISRCTN56745572 ### Clinical Protocols <https://pubmed.ncbi.nlm.nih.gov/19439742/> ### Funding Statement Yes ### Author Declarations I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained. Yes The details of the IRB/oversight body that provided approval or exemption for the research described are given below: Children's Hospital of Eastern Ontario Research Ethics Board gave approval in May 2004 for the CanBEST study with REB Number 02/59E. I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals. Yes I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance). Yes I have followed all appropriate research reporting guidelines, such as any relevant EQUATOR Network research reporting checklist(s) and other pertinent material, if applicable. Yes Data cannot be shared publicly because participants of this study did not agree for their data to be shared publicly. Data are available from CHEO for researchers who meet the criteria for access to confidential data.
Background: Bronchiolitis exerts a significant burden of illness on infants worldwide predominantly due to need for hospitalization. Currently only supportive care is advised by national guidelines for infants with bronchiolitis. There is evidence that treating infants with bronchiolitis with a combination of inhaled epinephrine and dexamethasone may reduce hospital admissions. Synergy between beta-agonists and corticosteroids is recognized in asthma management and basic science literature demonstrates that co-administration of these medications enhances each other’s effectiveness. Objective: To determine if infants with bronchiolitis treated with inhaled epinephrine (delivered by metered dose inhaler with spacer or nebulizer) in the emergency department and a 2-day course of oral dexamethasone have fewer hospitalizations (due to bronchiolitis) over 7 days compared to infants treated with placebo. Design: The BIPED study (Bronchiolitis in Infants Epinephrine versus Dexamethasone and Placebo) is a randomized, placebo-controlled, observer, investigator, clinician, and patient blinded superiority clinical trial being conducted in 12 emergency departments across three countries (Canada, New Zealand, and Australia). We will recruit 864 infants between 60 days and 12 months of age with bronchiolitis to receive either (1) two inhaled epinephrine treatments (3 mg via nebulizer or 625 mcg via metered dose inhaler with spacer) 30 minutes apart and a simultaneous dose of oral dexamethasone (0.6 mg/kg, maximum 10 mg) in the emergency department with the dexamethasone repeated at 24 hours or (2) inhaled placebo and oral placebo. The primary outcome is hospital admission for bronchiolitis within 7 days (168 hours) of enrolment. Secondary outcomes include hospital admission during enrolment, and all cause hospital admissions and healthcare provider visits within 21 days of enrolment. We will use a Bayesian approach for data analysis and inference. Discussion: Given the healthcare burden of bronchiolitis, there is urgent need for a trial to confirm if combination therapy with epinephrine and dexamethasone is effective. Trial registration: ClinicalTrials.gov: [NCT03567473][1]. Registered on 2018-06-13. Protocol version: CTO 1423, dated 20 January 2023 Sponsor-Investigator: Dr. Amy C Plint, Children’s Hospital of Eastern Ontario, Ottawa, Ontario, Canada Secondary Sponsor: Children’s Hospital of Eastern Ontario Research Institute, Ottawa, Ontario, Canada ### Competing Interest Statement The authors have declared no competing interest. ### Clinical Trial ClinicalTrials.gov: [NCT03567473][1] ### Funding Statement This study was funded by the following. Canadian Institutes of Health Research. National Health Medical Research Council. Perth Childrens Hospital Foundation. Telethon Perth Childrens Hospital Research Fund. Starship Foundation. Cure Kids New Zealand. Childrens Hospital Research Institute of Manitoba and Research Manitoba. Women and Childrens Health Research Institute. Alberta Childrens Hospital Research Institute. Childrens Hospital of Eastern Ontario Research Institute. Hospital for Sick Children Research Institute. Department of Pediatrics at the University of Western Ontario. Centre Hospitalier Universitaire Ste Justine. ACP is supported by a University of Ottawa Research Chair. AH and TPK are supported Canada Research Chairs. SRD is supported by the Cure Kids Chair of Child Health Research. ### Author Declarations I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained. Yes The details of the IRB/oversight body that provided approval or exemption for the research described are given below: Ethics committee of Centre Hospitalier Universitaire Sainte-Justine gave ethical approval for this work. Ethics committee of the Childrens Hospital of Eastern Ontario gave ethical approval for this work. Ethics committee of the University of Manitoba (Biomedical Research Board) gave ethical approval for this work. Ethics committee of the University of Alberta gave ethical approval for this study. Ethics committee of the University of Calgary gave ethical approval for this work. The Health and Disability Ethics Committee of New Zealand gave ethic approval for this study. The Child and Adolescent Health Services Human Research Ethics Committee of Australia gave ethical approval for this study. I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals. Yes I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance). Yes I have followed all appropriate research reporting guidelines, such as any relevant EQUATOR Network research reporting checklist(s) and other pertinent material, if applicable. Yes De-identified data from this study may be requested by other researchers 2 years after the publication of the primary manuscript by contacting the principal investigator (ACP). Consent for this data sharing will be obtained at the time of consent to enrolment in the trial. Researchers that wish to study the data must have the new study approved by a research ethics board and sign an agreement ensuring confidentiality and restricting data use only to the approved study. [1]: /lookup/external-ref?link_type=CLINTRIALGOV&access_num=NCT03567473&atom=%2Fmedrxiv%2Fearly%2F2024%2F12%2F08%2F2024.12.05.24318262.atom
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.
BackgroundDespite 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.MethodsOur 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.ResultsWe 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.ConclusionIn 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.
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 (ISRCTN56745572, post-results) 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.
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
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 6β-hydroxycortisol-cortisol ratio.RESULTS:Twenty-seven children were analyzed (22 with croup and 5 with upper respiratory tract infections). Median 6β-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 6β-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.
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.
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.
Journal Article 116 Hyoscine butylbromide (Buscopan) for abdominal pain in children: a randomized controlled trial Get access Naveen Poonai, Naveen Poonai Western University Search for other works by this author on: Oxford Academic Google Scholar Sharlene Elsie, Sharlene Elsie Western University Search for other works by this author on: Oxford Academic Google Scholar Kriti Kumar, Kriti Kumar Western University Search for other works by this author on: Oxford Academic Google Scholar Kamary Coriolano, Kamary Coriolano Western University Search for other works by this author on: Oxford Academic Google Scholar Shaily Brahmbhatt, Shaily Brahmbhatt Western University Search for other works by this author on: Oxford Academic Google Scholar Emily Dzongkowski, Emily Dzongkowski Western University Search for other works by this author on: Oxford Academic Google Scholar Holly Stevens, Holly Stevens Western University Search for other works by this author on: Oxford Academic Google Scholar Priti Gupta, Priti Gupta Western University Search for other works by this author on: Oxford Academic Google Scholar Michael Miller, Michael Miller Western University Search for other works by this author on: Oxford Academic Google Scholar Dhandapani Ashok, Dhandapani Ashok Western University Search for other works by this author on: Oxford Academic Google Scholar ... Show more Gary Joubert, Gary Joubert Western University Search for other works by this author on: Oxford Academic Google Scholar Andreana Butter, Andreana Butter Western University Search for other works by this author on: Oxford Academic Google Scholar Samina Ali Samina Ali University of Alberta Search for other works by this author on: Oxford Academic Google Scholar Paediatrics & Child Health, Volume 24, Issue Supplement_2, June 2019, Pages e44–e45, https://doi.org/10.1093/pch/pxz066.115 Published: 31 May 2019
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.
Introduction: Abdominal pain is one of the most frequent reasons for an emergency department (ED) visit. Most cases are functional and no therapy has proven effective. Our objective was to determine if hyoscine butylbromide (HBB) (BuscopanTM) is effective for children who present to the ED with functional abdominal pain. Methods: We conducted a randomized, blinded, superiority trial comparing HBB 10 mg plus acetaminophen placebo to oral acetaminophen 15 mg/kg (max 975 mg) plus HBB placebo using a double-dummy approach. We included children 8-17 years presenting to the ED at London Health Sciences Centre with colicky abdominal pain rated >40 mm on a 100 mm visual analog scale (VAS). The primary outcome was VAS pain score at 80 minutes post-administration. Secondary outcomes included adverse effects; caregiver satisfaction with pain management using a five-item Likert scale; recidivism and missed surgical diagnoses within 24-hours of discharge. Analysis was based on intention to treat. Results: We analyzed 225 participants (112 acetaminophen; 113 HBB). The mean (SD) age was 12.4 (3.0) years and 148/225 (65.8%) were females. Prior to enrollment, the median (IQR) duration of pain prior was 2 (4.5) hours and analgesia was provided to 101/225 (44.9%) of participants. The mean (SD) pre-intervention pain scores in the acetaminophen and HBB groups were 62.7 (15.9) mm and 60.3 (17.3) mm, respectively. At 80 minutes, the mean (SD) pain scores in the acetaminophen and HBB groups were 30.1 (28.8) mm and 29.4 (26.4) mm, respectively and there were no significant differences adjusting for pre-intervention scores (p = 0.96). The median (IQR) caregiver satisfaction was high in the acetaminophen [5 (2)] and HBB [5 (1)] groups (p = 0.79). The median (IQR) length of stay between acetaminophen [235 (101)] and HBB [234 (103)] was not significantly different (p = 0.53). The proportion of participants with a return visit for abdominal pain was 4/112 (3.5%) in the acetaminophen group and 6/113 (5.3%) in the HBB group. The most common adverse effect was nausea (9% in each group) and there were no significant differences in adverse effects between acetaminophen (26/112, 23.2%) and HBB (31/113, 27.4%) (p = 0.52). There were no missed surgical diagnoses. Conclusion: For children with presumed functional abdominal pain who present to the ED, both acetaminophen and HBB produce a clinically important (VAS < 30 mm) reduction in pain and should be routinely considered in this clinical setting.
BACKGROUNDParents take neonates to the emergency department for many reasons, often nonurgent, pressuring an already burdened system. We aimed to characterize these visits and families to identify potential strategies to decrease neonatal emergency department visits.METHODSWe developed and implemented a survey that explored characteristics of neonates and parents/guardians evaluated in the emergency department, perspectives of parents and use of health care services. Parents presenting with a neonate to the emergency department in 5 large academic hospitals in Ontario were surveyed between December 2013 and June 2015. We used descriptive statistics to report survey data and explored correlations between factors.RESULTSA total of 1533 surveys were completed. The most common reasons for presenting were jaundice (441 [28.8%]) and feeding issues (251 [16.4%]). The majority of respondents (73.9% [1104/1494]) had received advice before going to the emergency department. In most cases (86.4% [954/1104]), this was from a health care provider, who frequently advised going to the emergency department. Although most parents (86.8% [1280/1475]) reported high confidence in caring for a sick or injured child, 42.3% (643/1519) were unsure of the severity, and most (90.4% [578/639]) of these parents felt that the infant required assessment immediately or the same day. Of parents who felt the condition was not serious, 83.2% (198/238) thought that same-day evaluation was required. Nearly half of respondents (44.4% [621/1400]) said they would have gone to their health care provider with a same-day appointment, and 28.1% (344/1225) would have gone to their care provider with a next-day appointment.INTERPRETATIONParents' reported confidence in caring for sick or injured infants does not match the perceived urgency of neonatal conditions, which likely contributes to emergency department overuse. Any system to decrease nonurgent emergency department use by neonates would need to be immediately responsive, providing same-day help.