Optimization of Antibiotic Prophylaxis Delivery for Pediatric Surgical Procedures.

OBJECTIVES: To optimize prophylactic antibiotic timing and delivery across all surgeries performed at a single large pediatric tertiary care center. METHODS: A multidisciplinary surgical quality team conducted a quality improvement initiative from July 2015 to December 2019 by using the A3 problem-solving method to identify and evaluate interventions for appropriate antibiotic administration. The primary outcome measure was the percentage of surgical encounters for pediatric patients with appropriate timing of antibiotic administration before surgical incision. Surgical site infection rates was the secondary outcome. Intervention effectiveness was assessed by using statistical process control. RESULTS: A total of 32 192 eligible surgical cases for pediatric patients were completed during the study period. Identified barriers to timely perioperative antibiotic administration included failure to order antibiotics before the surgical date and lack of antibiotic availability in the operating room at the time of administration. Resulting sequential interventions included updating institutional guidelines to reflect procedure-specific antibiotic choices and clarifying timing of administration to optimize pharmacokinetics, creating a hard-stop antibiotic order within electronic health record case requests, optimizing pharmacy and nursing workflow, and implementing an automatic antibiotic prophylaxis timer in the operating room. Administration of prophylactic antibiotics during the recommended preincision time window significantly improved; the correct timing was recorded in 38.6% of preintervention cases versus 94.0% at the conclusion of rollout of the sequential interventions (P < .001). Surgical site infection rates remained stable. CONCLUSIONS: Here we demonstrate utility of the A3 problem-solving schematic to successfully optimize prophylactic antibiotic timing and delivery in the surgical setting for pediatric patients by implementing systems-based interventions.

Acetaminophen clearance during ex vivo continuous renal replacement therapies.

Intravenous acetaminophen is an adjuvant to opioid use in critically ill and surgical patients requiring continuous renal replacement therapy (CRRT). The objective of this study was to determine the ex vivo transmembrane clearance of intravenous acetaminophen during continuous hemofiltration and hemodialysis. Transmembrane clearance was assessed using a validated ex vivo bovine blood model for CRRT using an F8 or HF1400 hemodiafilter. Ultrafiltrate and dialysate flow rates were 1, 2, and 3 L/h. Urea and acetaminophen clearances were calculated and compared. Acetaminophen was readily cleared by continuous hemofiltration with both hemodiafilters. Acetaminophen clearance rates were 92-98% of ultrafiltrate production rates. Similarly, dialytic acetaminophen clearances approximated dialysate flow rates for both hemodiafilters. Acetaminophen is readily cleared by CRRT. Patients receiving CRRT and acetaminophen may require increased doses for adequate pain control.

Retrospective evaluation of antimicrobial prophylaxis in prevention of surgical site infection in the pediatric population.

BACKGROUND AND OBJECTIVES: Few studies have been conducted in pediatric patients evaluating efficacy of prophylactic antibiotics for prevention of surgical site infection (SSI). This retrospective study was undertaken to determine the effect of antibiotic prophylaxis in the prevention of SSI in children. METHODS: With IRB approval, our perioperative electronic clinical information database was queried. Pediatric patients (≤18 years) undergoing general surgery, cardiac surgery, and spinal surgery at Mott Children's Hospital from January 2000 to April 2010 were included. Demographics and preoperative data were obtained from the Centricity Intraoperative Database, and any episodes of SSI were obtained by review of the infection control records. RESULTS: A total 5023 pediatric patients underwent surgery from January 2000 to April 2010. The average age of the children in the sample was 4.16 ± 5.5 years, and of these, 57% were boys. Overall, 119 (2.37%) cases of SSI were identified. There were no associations between the various patient factors and the development of SSIs. Children for whom antibiotics were administered incorrectly had a 1.7-fold increased risk of SSIs compared with children who received antibiotics within the recommended guidelines (P < 0.02). Children who received antibiotics were more likely to suffer an SSI compared with those who did not. CONCLUSIONS: Proper administration of preoperative antibiotics in pediatric patients is one of the few modifiable and significant factors in prevention of SSI.

Extended stability of intravenous acetaminophen in syringes and opened vials.

PURPOSE: The stability of i.v. acetaminophen beyond the manufacturer-recommended usage limit of six hours for opened vials was evaluated. METHODS: Intravenous acetaminophen (10 mg/mL) was obtained. Three identical samples of 100 mg (10 mL in a 10-mL syringe), 250 mg (25 mL in a 30-mL syringe), 500 mg (50 mL in a 60-mL syringe), 250 mg (25 mL in the original vial), and 900 mg (90 mL in original vial) were prepared. A 0.5-mL volume of each sample was withdrawn, diluted with mobile phase to an expected concentration of 50 µg/mL, and assayed in duplicate using high-performance liquid chromatography immediately after preparation and at 24, 48, 72, and 84 hours. The samples were visually inspected for any change in color, and pH was assessed at each time of analysis. The stability of the solutions was determined by calculating the percentage of the initial acetaminophen concentration remaining at each test hour. Stability was defined as the retention of at least 90% of the initial acetaminophen concentration. RESULTS: At least 99% of the initial concentration of acetaminophen remained in the original vials and polypropylene syringes throughout the 84-hour study period. There were no detectable changes in color, pH, visible microbial growth, or visible drug precipitation. CONCLUSION: Intravenous acetaminophen (10 mg/mL) was physically and chemically stable in a range of volumes for up to 84 hours in the opened vials and in polypropylene syringes at room temperature.

Contribution of body mass index to postoperative outcome in minority patients.

OBJECTIVE: The purpose of this investigation was to examine the association of body mass index (BMI) category with short-term outcomes in minority surgical patients-a relationship that previously has not been well characterized. METHODS: Data from the National Surgical Quality Improvement Program were used to calculate the BMI of minority patients undergoing surgery from 2005 to 2008. Patients were stratified into 5 BMI classes. Stepwise logistic regression was used to calculate odds ratios for mortality after controlling for known clinically relevant covariates. MAIN OUTCOME MEASURES: Morbidity and mortality at 30 days, across all 5 BMI classes. RESULTS: Among 119,619 minority patients studied, 50% were African American, 36% Hispanic, 10% Asian and Pacific Islanders, and 4% American Indian and Alaskan natives. Seventy percent were overweight or obese. Women were more likely to be obese or severely obese. The overall mortality rate was 1.5%, and this varied significantly by BMI class. Distribution of 30-day mortality demonstrated a progressive decrease, with the highest risk of death in the underweight class, and the lowest risk of death in the severely obese class. This relationship was maintained, even in patients with at least 1 major postoperative complication. CONCLUSION: The prevalence of being overweight or obese was high in this nationally representative cohort of minority surgical patients. Although BMI class is a significant predictor of 30-day mortality, the effect appeared paradoxical. The poorest outcomes were in the underweight and normal BMI patients. Severely obese patients had the lowest risk of mortality, even after experiencing a major postoperative complication.

A systematic approach to improving medication safety in a pediatric intensive care unit.

Safety and quality improvement are major issues in children's hospitals. Improving pediatric medication safety often takes on a larger role in pediatric units than in adult units due to the larger size differences and dose ranges found in a pediatric intensive care unit. This article reviews the literature and our own experience at the CS Mott Children's Hospital, University of Michigan, to improve medication safety. The issues identified include (1) an effective pediatric medication safety governance structure within a larger hospital, (2) practice standardization strategies for physicians, nurses, and pharmacists, (3) use of pharmacy technicians as unit medication managers, which reduces medication costs and decreases nursing time spent hunting for medications, and (4) methods to improve the safety culture in a pediatric intensive care unit.

Epidural analgesia compared with intravenous analgesia after pediatric posterior spinal fusion.

BACKGROUND: Pain management remains challenging for pediatric patients after posterior spinal fusion (PSF). This study compares the effectiveness of hydromorphone and bupivacaine administered through patient-controlled epidural analgesia (PCEA) with hydromorphone patient-controlled intravenous analgesia (IV-PCA) in this population. METHODS: Patients aged 8 to 18 years undergoing PSF for idiopathic scoliosis were randomized to receive either PCEA (0.1% bupivacaine plus hydromorphone 10 mcg/mL at 8 mL/h plus bolus dosing) or IV-PCA (hydromorphone 2 mcg/kg/h continuous infusion; 2 mcg/kg bolus dose). Pain scores, severity of muscle spasms, and analgesic doses were recorded for 3 postoperative days (PODs). Adverse events were followed until discharge. RESULTS: Thirty-eight patients were included (19 PCEA and 19 IV-PCA). Seven in the PCEA group (37%) experienced early epidural failure, and 2 in the IV-PCA group remained intubated, sedated, and ventilated for several hours postoperatively; these patients were included in the intention-to-treat analysis. All data are presented as "per protocol" unless otherwise specified. Pain scores were significantly lower on days 2 and 3 (P < or = 0.042). Eight percent of the patients who received PCEA experienced moderate-to-severe spasms through POD 3 compared with 35% of those in the IV-PCA group (P=NS). Seven (58%) patients in the PCEA group and 17 (100%) in the IV-PCA group required diazepam (P=0.007). CONCLUSIONS: Epidural catheters provide modestly improved analgesia in patients after PSF for idiopathic scoliosis. However, the high failure rate in this population emphasizes a need for a close assessment for adequate blockade early in the recovery period. This study provides an excellent platform on which to build future trials that could include increased baseline dosing for the epidural medications, radiographic confirmation of catheter placement, and dual catheter techniques toward the goal of improving pain control in these patients. LEVEL OF EVIDENCE: Level 2, randomized, controlled trial.

Assessing parents preferences for the avoidance of undesirable anesthesia side effects in their children undergoing surgical procedures.

BACKGROUND: Willingness to pay (WTP) surveys have proven to be useful tools in determining patient preferences though relatively few pediatric studies have utilized them. Studies in the adult surgical population have used such methods to assess patients' perspectives regarding the avoidance of anesthesia side effects or outcomes. The purpose of this survey was to assess parental preferences, using a relative WTP model, for the avoidance of anesthesia side effects in their children undergoing surgery. METHODS: The survey was distributed to 150 parents of children who were undergoing surgery. Parents were asked to rank order (1 = most unwanted to 7 = least troublesome) six stated potential anesthesia side effects and to allocate a fixed dollar percentage of a $100 toward prevention of each. A total of 142 surveys were returned (95% response rate). RESULTS: Parents ranked vomiting as the least desirable side effect for their child (rank order = 1.9) and pain as second (rank order = 2.14). However, parents allocated $33.48 to prevent pain compared with $28.89 for vomiting as a relative dollar amount. CONCLUSIONS: This study suggests that targeting management toward the prevention of these adverse outcomes may improve parental satisfaction with anesthesia care of their children.

Ondansetron oral disintegrating tablets for the prevention of postoperative vomiting in children undergoing strabismus surgery.

Strabismus surgery in pediatric patients is associated with a high incidence of postoperative nausea and vomiting (PONV). Ondansetron disintegrating tablets (ODT), an oral freeze-dried formulation of the 5-HT(3) antagonist, are well-tolerated and have been shown to reduce chemotherapy-induced vomiting. The purpose of this study was to assess the efficacy of the ODT in preventing postoperative vomiting (POV) in children undergoing strabismus repair. Healthy children aged 4-12 years of age were administered a 4 mg ODT 30 minutes prior to the induction of general anesthesia. Induction and maintenance of anesthesia were standardized; each child received acetaminophen and ketorolac pre-emptively for analgesia. This study group was compared with a historical control group who received a placebo in previously conducted identical trials of POV. The 35 children included in this study were compared with 31 controls. The incidence and severity of POV and use of rescue antiemetics were significantly lower in children who received ODT compared with placebo (p

Stability of dolasetron in two oral liquid vehicles.

The stability of dolasetron 10 mg/mL over 90 days when prepared as an oral liquid formulation from commercially available tablets in both strawberry syrup and a sugar-free vehicle was studied. A liquid suspension of dolasetron mesylate 10 mg/mL was prepared from commercially available dolasetron tablets, OraPlus, and Ora-Sweet or strawberry syrup. Six samples of each formulation were prepared and stored in amber plastic bottles. Three samples of each formulation were refrigerated (3-5 degrees C) and three were stored at room temperature (23-25 degrees C). A 1-mL sample was withdrawn from each of the 12 bottles immediately and after 7, 14, 30, 60, and 90 days. After further dilution to an expected concentration of 10 micrograms/mL with sample diluent, the solutions were assayed in duplicate using high-performance liquid chromatography. The samples were also inspected for color and odor changes, and the pH of each sample was determined. The stability-indicating capability of the dolasetron assay was determined by forced degradation of four separate 10-mg/mL samples exposed to direct sunlight for 90 days. There were no detectable changes in color, odor, or taste and no visible microbial growth in any sample. At least 98% of the initial dolasetron concentration remained throughout the 90-day study period for all samples. An extemporaneously compounded oral liquid preparation of dolasetron mesylate 10 mg/mL in a 1:1 mixture of Ora-Plus and strawberry syrup or Ora-Sweet was stable for at least 90 days when stored at 3-5 or 23-25 degrees C.

Relative analgesic potencies of levobupivacaine and ropivacaine for epidural analgesia in labor.

BACKGROUND: The minimum local analgesic concentration has been defined as the median effective local analgesic concentration (EC50) in a 20-ml volume for epidural analgesia in the first stage of labor. The aim of this study was to assess the relative analgesic potencies of epidural levobupivacaine and ropivacaine by determination of their respective minimum local analgesic concentrations. METHODS: Parturients at 7 cm of cervical dilation or less who requested epidural analgesia were allocated to one of two groups in this double-blind, randomized, prospective study. After lumbar epidural catheter placement, 20 ml of the test solution was given: levobupivacaine (n = 35) or ropivacaine (n = 35). The concentration of local anesthetic was determined by the response of the previous patient in that group to a higher or lower concentration using up-down sequential allocation. Analgesic efficacy was assessed using 100-mm visual analog pain scale scores, with 10 mm or less within 30 min defined as effective. An effective result directed a 0.01% wt/vol decrement for the next patient. An ineffective result directed a 0.01% wt/vol increment. RESULTS: Of 105 women enrolled, 35 were excluded, leaving 70 for analysis. The minimum local analgesic concentration of levobupivacaine was 0.087% wt/vol (95% CI, 0.081-0.094%), and the minimum local analgesic concentration of ropivacaine was 0.089% wt/vol (95% CI, 0.075-0.103%). Levobupivacaine and ropivacaine were of similar potency with a ropivacaine:levobupivacaine potency ratio of 0.98 (95% CI, 0.80-1.20). No difference in motor effects was observed. CONCLUSIONS: This study demonstrated that levobupivacaine and ropivacaine are of similar potency for epidural analgesia in the first stage of labor.

Effect of epidural epinephrine on the minimum local analgesic concentration of epidural bupivacaine in labor.

BACKGROUND: The minimum local analgesic concentration (MLAC) has been defined as the median effective local analgesic concentration in a 20-ml volume for epidural analgesia in the first stage of labor. The aim of this study was to determine the local anesthetic-sparing efficacy of epidural epinephrine by its effect on the MLAC of bupivacaine. METHODS: In this double-blind, randomized, prospective study, 70 parturients who were at 7 cm or less cervical dilation and who requested epidural analgesia were allocated to one of two groups. After lumbar epidural catheter placement, 20 ml bupivacaine (n = 35) or bupivacaine with epinephrine 1:300,000 (n = 35) was administered. The concentration of bupivacaine was determined by the response of the previous patient in that group to a higher or lower concentration using up-down sequential allocation. Analgesic efficacy was assessed using 100-mm visual analog pain scores, with 10 mm or less within 30 min defined as effective. RESULTS: The MLAC of bupivacaine alone was 0.091% wt/vol (95% confidence interval, 0.081-0.102). The addition of epinephrine 1:300,000 (66.7 microg) resulted in a significant reduction (P < 0.01) in the MLAC of bupivacaine to 0.065% wt/vol (95% confidence interval, 0.047-0.083). The lowest maternal blood pressure was significantly lower in the bupivacaine-epinephrine group (P = 0.03). There were statistically significant reductions in fetal heart rate (P = 0.011) in the bupivacaine-epinephrine group that were not clinically significant. CONCLUSIONS: The addition of epidural epinephrine 1:300,000 (66 microg) resulted in a significant 29% reduction in the MLAC of bupivacaine. Coincident reductions in fetal heart rate and maternal blood pressure were also observed that were not clinically significant.