Objectives: Opioids and benzodiazepines are commonly used to provide analgesia and sedation for critically ill children with cardiac disease. These medications have been associated with adverse effects including delirium, dependence, withdrawal, bowel dysfunction, and potential neurodevelopmental abnormalities. Our objective was to implement a risk-stratified opioid and benzodiazepine weaning protocol to reduce the exposure to opioids and benzodiazepines in pediatric patients with cardiac disease. Design: A prospective pre- and postinterventional study. Patients: Critically ill patients less than or equal to 21 years old with acquired or congenital cardiac disease exposed to greater than or equal to 7 days of scheduled opioids ± scheduled benzodiazepines between January 2013 and February 2015. Setting: A 24-bed pediatric cardiac ICU and 21-bed cardiovascular acute ward of an urban stand-alone children’s hospital. Intervention: We implemented an evidence-based opioid and benzodiazepine weaning protocol using educational and quality improvement methodology. Measurements and Main Results: One-hundred nineteen critically ill children met the inclusion criteria (64 post intervention, 55 pre intervention). Demographics and risk factors did not differ between groups. Patients in the postintervention period had shorter duration of opioids (19.0 vs 30.0 d; p < 0.01) and duration of benzodiazepines (5.3 vs 22.7 d; p < 0.01). Despite the shorter duration of wean, there was a decrease in withdrawal occurrence (% Withdrawal Assessment Tool score ≥ 4, 4.9% vs 14.1%; p < 0.01). There was an 8-day reduction in hospital length of stay (34 vs 42 d; p < 0.01). There was a decrease in clonidine use (14% vs 32%; p = 0.02) and no change in dexmedetomidine exposure (59% vs 75%; p = 0.08) in the postintervention period. Conclusions: We implemented a risk-stratified opioid and benzodiazepine weaning protocol for critically ill cardiac children that resulted in reduction in opioid and benzodiazepine duration and dose exposure, a decrease in symptoms of withdrawal, and a reduction in hospital length of stay.
Objectives Half of prescription drugs commonly given to children lack product labeling on pediatric safety, efficacy, and dosing. Two drugs most widely used off-label in pediatrics are azithromycin and fentanyl. We sought to determine the risk of serious adverse events (SAEs) when oral azithromycin or intravenous/intramuscular fentanyl are used off-label compared to on-label in pediatric intensive care units (ICUs). Study Design Six pediatric hospitals participated in a retrospective chart review of patients administered oral azithromycin (n = 241) or intravenous/intramuscular fentanyl (n = 367) between January 5, 2013 and December 26, 2014. Outcomes were SAEs by drug and labeling status: off-label compared to on-label by Food and Drug Administration (FDA)-approved age and/or indication. Statistical analysis was performed using logistic regression to estimate odds ratios (ORs) and Cox regression to estimate hazard ratios (HRs). Results Twenty-one (9%) children receiving azithromycin experienced SAEs. Off-label use of azithromycin was not associated with a higher risk of SAE (OR 0.87, 95% CI 0.27–2.71, p = 0.81). Ninety-five (26%) children receiving fentanyl experienced SAEs. Fentanyl off-label use by both age and indication was not associated with a higher risk of overall SAEs compared to on-label use (OR 1.99, 95% CI 0.94–4.19, p = 0.07). However, the risk of the SAE respiratory depression was significantly greater when fentanyl was used off-label by both age and indication (OR 5.05, 95% CI 1.08–23.56, p = 0.044). Results based on HRs were similar. Conclusions Azithromycin off-label use in pediatric ICUs does not appear to be associated with an increased risk of SAEs. Off-label use of fentanyl appears to be more frequently associated with respiratory depression when used off-label by both age and indication in pediatric ICUs. Prospective studies should be undertaken to assess the safety and efficacy of fentanyl in the pediatric population so that data can be added to the FDA labeling.
OBJECTIVES Postoperative fluid overload is ubiquitous in neonates and infants following operative intervention for congenital heart defects; ineffective diuresis is associated with poor outcomes. Diuresis with furosemide is widely used, yet there is often resistance at higher doses. In theory, furosemide resistance may be overcome with chlorothiazide; however, its efficacy is unclear, especially in lower doses and in this population. We hypothesized the addition of lower-dose, intravenous chlorothiazide following surgery in patients on high-dose furosemide would induce meaningful diuresis with minimal side effects. METHODS This was a retrospective, cohort study. Postoperative infants younger than 6 months, receiving high-dose furosemide, and given lower-dose chlorothiazide (1–2 mg/kg every 6–12 hours) were identified. Diuretic doses, urine output, fluid balance, vasoactive-inotropic scores, total fluid intake, and electrolyte levels were recorded. RESULTS There were 73 patients included. The addition of lower-dose chlorothiazide was associated with a significant increase in urine output (3.8 ± 0.18 vs 5.6 ± 0.27 mL/kg/hr, p < 0.001), more negative fluid balance (16.1 ± 4.2 vs −25.0 ± 6.3 mL/kg/day, p < 0.001), and marginal changes in electrolytes. Multivariate analysis was performed, demonstrating that increased urine output and more negative fluid balance were independently associated with addition of chlorothiazide. Subgroup analysis of 21 patients without a change in furosemide dose demonstrated the addition of chlorothiazide significantly increased urine output (p = 0.03) and reduced fluid balance (p < 0.01), further validating the adjunct effects of chlorothiazide. CONCLUSION Lower-dose, intravenous chlorothiazide is an effective adjunct treatment in postoperative neonates and infants younger than 6 months following cardiothoracic surgery.
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