clinicaltrials.gov Identifier: NCT01718275.

Background This study reports national estimates of population characteristics and outcomes for patients with EA/TEF and evaluates relationships between hospital volume and outcomes. Methods Patients admitted within 30 days of life who had ICD-9-CM diagnosis and procedure codes relevant to EA/TEF during 1999–2012 were identified using the Pediatric Health Information System database. Baseline demographics, comorbidities, and post-operative outcomes, including predictors of in-hospital mortality, were examined up to 2 years following EA/TEF repair. Results We identified 3479 patients with EA/TEF treated at 43 children’s hospitals; 37% were premature and 83.5% had ≥1additional congenital anomaly, with cardiac anomalies (69.6%) being the most prevalent. Within two years of discharge, 54.7% were readmitted, 5.2% had a repeat TEF ligation, 11.4% had a repeat operation for their esophageal reconstruction, and 11.7% underwent fundoplication. In-hospital mortality was 5.4%. Independent predictors of mortality included lower birth weight, congenital heart disease, other congenital anomalies, and preoperative mechanical ventilation. There was no significant relationship between hospital volume and mortality or repeat TEF ligation. Conclusions This study describes population characteristics and outcomes, including predictors of in-hospital mortality, in EA/TEF patients treated at children’s hospitals across the United States. Across these hospitals, rates of mortality or repeat TEF ligation were not dependent on hospital volume.

IMPORTANCE Although opioids are an important component of pain management for children recovering from surgery, postoperative opioid prescribing has contributed to the current opioid crisis in the United States because these medications are often prescribed in excess and are rarely properly disposed. One potential strategy to combat opioid misuse is to remove excess postoperative opioids from circulation by providing patients with drug disposal products that enable safe disposal of opioids in the home garbage. OBJECTIVE To determine whether the provision of a drug disposal bag increases proper opioid disposal among the families of pediatric patients undergoing ambulatory surgery. DESIGN, SETTING, AND PARTICIPANTS This randomized clinical trial enrolled 202 parents or guardians of children 1 to 17 years of age who underwent otolaryngologic or urologic surgery at the outpatient surgery centers of a tertiary children's hospital in Columbus, Ohio, from June to December 2018 and who received an opioid prescription prior to discharge. INTERVENTIONS Families randomized to intervention were provided a drug disposal bag containing activated charcoal and instructions for use plus standard postoperative discharge instructions on opioid use, storage, and disposal. Families in standard care arm received standard postoperative discharge instructions only. All participants completed a baseline survey and a follow-up survey 2 to 4 weeks postoperatively. MAIN OUTCOMES AND MEASURES Primary outcome was proper opioid disposal, defined as disposal using a drug disposal bag or a disposal method recommended by the US Food and Drug Administration. RESULTS Of 202 parents or guardians enrolled, 181 completed follow-up (92 in intervention arm and 89 in standard care arm). Most patients in both groups were white (75 [73.5%] vs 79 [80.6%]) and male (63 [61.2%] vs 54 [54.6%]), and the median (interquartile range) age was 6 (5-9) years in the intervention arm and 7 (6-10) years in the standard care arm. For intention-to-treat analyses, 92 families receiving a disposal bag and 89 families not receiving a disposal bag were included. Among them, 66 families (71.7%) randomized to receive a disposal bag reported properly disposing of their child's opioids, whereas 50 parents (56.2%) who did not receive a disposal bag reported proper opioid disposal (difference in proportions, 15.5%; 95% CI, 1.7%-29.3%; P = .03). Among only those families who filled an opioid prescription and had leftover opioids after resolution of their child's pain, 66 of 77 parents or guardians (85.7%) who had received a disposal bag and 50 of 77 parents or guardians (64.9%) who had received standard care reported properly disposing of their child's opioids (difference in proportions, 20.8%; 95% CI, 7.6%-34.0%). CONCLUSIONS AND RELEVANCE Results of this study indicated that providing drug disposal bags to families of children receiving postoperative opioids increased the likelihood of excess opioid disposal. Greater availability of disposal products may complement ongoing prescr...

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