Pediatric opioid and benzodiazepine withdrawal are avoidable complications of pain and sedation management that is well described in the literature. To prevent withdrawal from occurring, practitioners regularly use a steady decrease of pain and sedation medications, also known as a weaning or tapering schedule. The weaning schedule is highly variable based on clinician preference and is usually dependent on the clinician. The purposes of this review are to evaluate the current literature on the process of opioid and benzodiazepine weaning in pediatric patients and to assess the various standardized protocols used to decrease withdrawal occurrences. We conducted a search of the PubMed, MEDLINE, Cochrane Library, Cumulative Index of Nursing and Allied Health (CINAHL), Academic Search Premier, and PsycInfo databases. Studies were included if they described a wean or taper in pediatric patients aged 18 years or younger. Studies describing neonatal abstinence syndrome were excluded from the review. A total of 97 studies published between 2000 and 2014 were retrieved; of those, 15 studies met the inclusion criteria. Studies were evaluated for selection of withdrawal assessment tool, wean protocol summary, preferred weaning agents, benzodiazepine withdrawal, and wean-at-home regimen. The most common opioid-weaning protocol approaches described a 10-20% dose decrease per day. Benzodiazepine weaning was not regularly standardized or described. The use of a standardized opioid-weaning protocol reduced withdrawal rates compared with nonstandardized weaning plans. Benzodiazepine weaning was inconsistently evaluated and may have affected study outcomes. Identified areas of improvement include the use of newer withdrawal assessment tools validated in the older pediatric population and standardized withdrawal assessment and reporting.
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.
A B S T R A C T BACKGROUND AND OBJECTIVE: Children receiving long-term antibiotic therapy (LTAT) atChildren's Hospital Colorado (CHCO) are treated with both oral and intravenous (IV) agents and often experience complications not comprehensively described by the literature. We sought to describe adverse drug events (ADEs) and venous access complications (VACs) in pediatric patients managed with oral and IV antibiotics so as to inform clinical decision-making, drug monitoring, and patient counseling at CHCO. METHODS:We conducted a retrospective review of children receiving LTAT through the CHCO infectious disease service from 2006 to 2012. Demographic, microbiologic, diagnostic data, ADEs, and VACs were recorded for each patient.RESULTS: From 2006 to 2012, 521 patients received 1876 courses, accounting for 71 306 days of antimicrobial therapy. A total of 219 patients (42 %) developed an ADE with discontinuation of the offending agent in 65% of courses associated with an ADE. The most common ADEs were neutropenia, rash, and diarrhea. Central lines were placed in 376 patients with 106 (28%) experiencing $1 VACs. IV agents were associated with a fourfold increase in the rate of ADEs compared with oral agents, and a fivefold increase when VACs were included. CONCLUSIONS:Practitioners may make more informed decisions and risk assessments by using descriptive ADE information for specific agents and mode of drug delivery to mitigate risk, thereby improving the quality of care. Patients should be counseled regarding risks of LTAT, including increased risk with IV therapy, and actively monitored for side effects.
Traumatic brain injury remains a leading cause of morbidity and mortality in children. The use of hyperosmolar therapy to offset increased intracranial pressure (ICP) is described in pediatric guidelines, yet some controversy remains regarding which option to select. A search was conducted using the PubMed, MEDLINE, Cumulative Index of Nursing and Allied Health, Academic Search Premier, PsycInfo, and Cochrane Library databases. Studies were included if they described the hyperosmolar therapy use, involved severe traumatic brain injury (TBI), and patient age was 0 to 18 years. A total of 331 studies published between 1987 and 2017 were retrieved; of these, 9 met the inclusion criteria. Included studies were evaluated for the type and concentration of hyperosmolar therapy, associated mortality outcomes, ICP and coronary perfusion pressure (CPP) measurements, concurrent medications, and reported serum sodium and serum osmolarity or osmolality values. Hypertonic saline was the most commonly reported hyperosmolar therapy. Mannitol was less studied, but collectively demonstrated a higher incidence of mortality than hypertonic saline. There were several studies that did not report monitoring outcomes associated with serum sodium and/or serum osmolarity, despite the use of hyperosmolar therapies. Inconsistencies were noted between the studies in the overall study design as well as reported monitoring parameters and length of stay. Hypertonic saline appears to be safe and efficacious at several concentrations for treatment of increased ICP associated with severe TBI in pediatric patients. The limited available data regarding the use of mannitol do not allow a strong conclusion to be made regarding its use.
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