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.

Prospective assessment of practice pattern variations in the treatment of pediatric gastroenteritis.

OBJECTIVES: We aimed to determine whether significant variations in the use of intravenous rehydration existed among institutions, controlling for clinical variables, and to assess variations in the use of ancillary therapeutic and diagnostic modalities. METHODS: We conducted a prospective cohort study of children 3 to 48 months of age who presented to 11 emergency departments with acute gastroenteritis, using surveys, medical record reviews, and telephone follow-up evaluations. RESULTS: A total of 647 eligible children were enrolled and underwent chart review; 69% (446 of 647 children) participated in the survey, and 89% of survey participants (398 of 446 children) had complete follow-up data. Twenty-three percent (149 of 647 children) received intravenous rehydration (range: 6%-66%; P < .001) and 13% (81 of 647 children) received ondansetron (range: 0%-38%; P < .001). Children who received intravenous rehydration had lower Canadian Triage Acuity Scale scores at presentation (3.1 ± 0.5 vs 3.5 ± 0.5; P < .0001). Regression analysis revealed that the greatest predictor of intravenous rehydration was institution location (odds ratio: 3.0 [95% confidence interval: 1.8-5.0]). Children who received intravenous rehydration at the index visit were more likely to have an unscheduled follow-up health care provider visit (29% vs 19%; P = .05) and to revisit an emergency department (20% vs 9%; P = .002). CONCLUSIONS: In this cohort, intravenous rehydration and ondansetron use varied dramatically. Use of intravenous rehydration at the index visit was significantly associated with the institution providing care and was not associated with a reduction in the need for follow-up care.

Cost-effectiveness of epinephrine and dexamethasone in children with bronchiolitis.

OBJECTIVE: Using data from the Canadian Bronchiolitis Epinephrine Steroid Trial we assessed the cost-effectiveness of treatments with epinephrine and dexamethasone for infants between 6 weeks and 12 months of age with bronchiolitis. METHODS: An economic evaluation was conducted from both the societal and health care system perspectives including all costs during 22 days after enrollment. The effectiveness of therapy was measured by the duration of symptoms of feeding problems, sleeping problems, coughing, and noisy breathing. Comparators were nebulized epinephrine plus oral dexamethasone, nebulized epinephrine alone, oral dexamethasone alone, and no active treatment. Uncertainty around estimates was assessed through nonparametric bootstrapping. RESULTS: The combination of nebulized epinephrine plus oral dexamethasone was dominant over the other 3 comparators in that it was both the most effective and least costly. Average societal costs were $1115 (95% credible interval [CI]: 919-1325) for the combination therapy, $1210 (95% CI: 1004-1441) for no active treatment, $1322 (95% CI: 1093-1571) for epinephrine alone, and $1360 (95% CI: 1124-1624) for dexamethasone alone. The average time to curtailment of all symptoms was 12.1 days (95% CI: 11-13) for the combination therapy, 12.7 days (95% CI: 12-13) for no active treatment, 13.0 days (95% CI: 12-14) for epinephrine alone, and 12.6 days (95% CI: 12-13) for dexamethasone alone. CONCLUSION: Treating infants with bronchiolitis with a combination of nebulized epinephrine plus oral dexamethasone is the most cost-effective treatment option, because it is the most effective in controlling symptoms and is associated with the least costs.

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.