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.

Knowledge, attitudes and practices of Canadian pediatric emergency physicians regarding short-term opioid use: a descriptive, cross-sectional survey.

BACKGROUND: In the midst of the current opioid crisis, physicians are caught between balancing children's optimal pain management and the risks of opioid therapy. This study describes pediatric emergency physicians' practice patterns for prescribing, knowledge and attitudes regarding, and perceived barriers to and facilitators of short-term use of opioids. METHODS: We created a survey tool using published methodology guidelines and distributed it from October to December 2017 to all physicians in the Pediatric Emergency Research Canada database using Dillman's tailored design method for mixed-mode surveys. We performed bivariable binomial logistic regressions to ascertain the effects of clinically significant variables (e.g., training, age, sex, degree of worry regarding severe adverse events) on use of opioids as a first-line treatment for moderate pain in the emergency department, and prescription of opioids for moderate or severe pain for at-home use in children. RESULTS: Of the 224 physicians in the database, 136 (60.7%) completed the survey (60/111 [54.1%] women; median age 44 yr). Of the 136, 74 (54.4%) had subspecialty training. Intranasally administered fentanyl was the most commonly selected opioid for first-line treatment of moderate (47 respondents [34.6%]) and severe (82 [60.3%]) pain due to musculoskeletal injury. On a scale of 0 (not worried) to 100 (extremely worried), physicians' median score for worry regarding physical dependence was 6.0 (25th percentile 0.0, 75th percentile 16.0), for worry regarding addiction 10.0 (25th percentile 2.0, 75th percentile 20.0) and for worry regarding diversion of opioids 24.5 (25th percentile 14.0, 75th percentile 52.0). On a scale of 0 (not at all) to 100 (extremely), the median score for influence of the opioid crisis on willingness to prescribe opioids was 22.0 (25th percentile 8.0, 75th percentile 49.0). The top 3 reported barriers to prescribing opioids were parental reluctance (57 [41.9%]), lack of clear guidelines for pediatric opioid use (35 [25.7%]) and concern about adverse effects (33 [24.3%]). Binomial logistic regression did not identify any statistically significant variables affecting use of opioids in the emergency department or prescribed for use at home. INTERPRETATION: Emergency department physicians appeared minimally concerned about physical dependence, addiction risk and the current opioid crisis when prescribing opioids to children. Evidence-based development of guidelines and protocols for use of opioids in children may improve physicians' ability to manage pain in children responsibly and adequately.

Development and pretesting of an electronic learning module to train health care professionals on the use of the Pediatric Respiratory Assessment Measure to assess acute asthma severity.

BACKGROUND: Severity-specific guidelines based on the Pediatric Respiratory Assessment Measure (PRAM), a validated clinical score, reduce pediatric asthma hospitalization rates. OBJECTIVE: To develop, pretest the educational value of and revise an electronic learning module to train health care professionals on the use of the PRAM. METHODS: The respiratory efforts of 32 children with acute asthma were videotaped and pulmonary auscultation was recorded. A pilot module, composed of a tutorial and 18 clinical cases, was developed in French and English. Health care professionals completed the module and provided feedback. The performance of participants, case quality and difficulty, and learning curve were assessed using the Rasch test; quantitative and qualitative feedback served to revise the module. RESULTS: Seventy-two participants (19 physicians, 22 nurses, four respiratory therapists and 27 health care trainees) with a balanced distribution across self-declared expertise (26% beginner, 35% competent and 39% expert) were included. The accuracy of experts was superior to beginners (OR 1.79, 1.15 and 2.79, respectively). Overall performance significantly improved between the first and latter half of cases (P<0.001). Participants assessed the module to be clear (96%), relevant (98%), realistic (94%) and useful (99%) to learn the PRAM. The qualitative/quantitative analysis led to the deletion of three cases, modification of remaining cases to further enhance quality and reordering within three levels of difficulty. DISCUSSION: Using rigorous educational methods, an electronic module was developed to teach health care professionals on use of the PRAM score. Using the back-translation technique, both French and English versions were developed and validated simultaneously. The pilot module comprised a tutorial and three case-scenario sections, and was tested on a target audience of physicians, nurses, respiratory therapists and medical trainees. CONCLUSION: The final electronic learning module met the clarity and quality requirements of a good teaching tool, with a demonstrated learning effect and high appreciation by health care professionals. Available in French and English, it is offered to facilitate implementation of PRAM-based acute pediatric asthma guidelines.

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.