A multicenter study to evaluate the pharmacokinetics and safety of liposomal bupivacaine for postsurgical analgesia in pediatric patients aged 6 to less than 17 years (PLAY).

Efficacy of liposomal bupivacaine in spine surgery: a systematic review.

**Background:** Approximately 60% of hospitalized children undergoing surgery experience at least 1 day of moderate-to-severe pain after surgery. Pain following spine surgery may affect opioid exposure, length of stay (LOS), and costs in hospitalized pediatric patients. This is a retrospective cohort analysis of pediatric patients undergoing inpatient primary spine surgery.

**Objectives:** To examine the association of opioid-related and economic outcomes with postsurgical liposomal bupivacaine (LB) or non-LB analgesia in pediatric patients who received spine surgery.

**Methods:** Premier Healthcare Database records (January 2015–September 2019) for patients aged 1–17 years undergoing inpatient primary spine surgery were retrospectively analyzed. Outcomes included in-hospital postsurgical opioid consumption (morphine milligram equivalents [MMEs]), opioid-related adverse events (ORAEs), LOS (days), and total hospital costs. A generalized linear model adjusting for baseline characteristics was used.

**Results:** Among 10 189 pediatric patients, the LB cohort (n=373) consumed significantly fewer postsurgical opioids than the non-LB cohort (n=9816; adjusted MME ratio, 0.53 [95% confidence interval (CI), 0.45–0.61]; P<0.0001). LOS was significantly shorter in the LB versus non-LB cohort (adjusted rate ratio, 0.86 [95% CI, 0.80–0.94]; P=0.0003). Hospital costs were significantly lower in the LB versus non-LB cohort overall (adjusted rate ratio, 0.92 [95% CI, 0.86–0.99]; P=0.0227) mostly because of decreased LOS and central supply costs. ORAEs were not significantly different between groups (adjusted rate ratio, 0.84 [95% CI, 0.65–1.08]; P=0.1791).

**Discussion:** LB analgesia was associated with shorter LOS and lower hospital costs compared with non-LB analgesia in pediatric patients undergoing spine surgery. The LB cohort had lower adjusted room and board and central supply costs than the non-LB cohort. These data suggest that treatment with LB might reduce hospital LOS and subsequently health-care costs, and additional cost savings outside the hospital room may factor into overall health-care cost savings. LB may reduce pain and the need for supplemental postsurgical opioids, thus reducing pain and opioid-associated expenses while improving patient satisfaction with postsurgical care.

**Conclusions:** Pediatric patients undergoing spine surgery who received LB had significantly reduced in-hospital postsurgical opioid consumption, LOS, and hospital costs compared with those who did not.

/pdf/clinical-and-economic-outcomes-associated-with-use-of-4sq36cq2yu.pdf

Clinical and Economic Outcomes Associated With Use of Liposomal Bupivacaine Versus Standard of Care for Management of Postsurgical Pain in Pediatric Patients Undergoing Spine Surgery.

Epilepsy is a common diagnosis and can quickly progress to status epilepticus which requires rapid treatment. Levetiracetam is a frequent treatment choice in these situations. The approved administration of intravenous levetiracetam is an infusion over 15 min. In recent years, studies have been published on faster infusion rates of levetiracetam. The objective of this review is to discuss the safety of levetiracetam as an intravenous push at a rate quicker than recommended. A literature search using PubMed, Cochrane Library, ClinicalTrials.gov, and Google Scholar resulted in 192 articles. Inclusion criteria consisted of English language, human studies, use of levetiracetam administered intravenously at a rate faster than 15 min, discussion of safety, and full‐text availability. After screening, nine articles remained for inclusion. Of the nine articles, one was a prospective, open‐label study, six were retrospective studies, and two were open‐label, randomized controlled trials. The most common rapid infusion speed was 5 min and doses ranged from 280 to 4500 mg. Some of these trials used undiluted levetiracetam and many reported that peripheral access was used for a portion or all of the administrations. There were few adverse effects, including specific adverse effects relating to medication concentration and speed of infusion, in all the studies. Administration of intravenous levetiracetam at a rate faster than recommended in the labeling information appears to be safe and tolerable and can be given via a peripheral line. Rapid infusion of levetiracetam is a beneficial method of administration in an acute care setting where patients need rapid attainment of therapeutic levels of antiepileptic medications. Additional research is needed to ensure that rapid administration of intravenous levetiracetam is as efficacious as the traditional dosing method.

The safety of rapid infusion levetiracetam: A systematic review

http://manuscript.elsevier.com/S187887502200376X/pdf/S187887502200376X.pdf

Perioperative Pain Management for Elective Spine Surgery: Opioid Use and Multimodal Strategies.

STUDY DESIGN Retrospective comparative cohort study. OBJECTIVE To evaluate: (1) pain relief efficacy; (2) opioid consumption; (3) length of stay (LOS); (4) discharge disposition (DD); and (5) safety and adverse effects of liposomal bupivacaine (LB) in pediatric patients who underwent spinal deformity correction. SUMMARY OF BACKGROUND DATA LB is a long-acting, locally injectable anesthetic. Previous orthopedic studies investigating its use have been limited to adult patients. The use of LB as part of postoperative pain management in pediatric patients undergoing spine deformity correction surgery is yet to be evaluated. MATERIALS AND METHODS A total of 195 patients that received LB as part of their postoperative pain management regimen were compared with 128 patients who received standard pain management without LB. Pain intensity, opioid consumption, LOS, and DD were recorded. Potential LB-related complications were reported as frequencies and statistically compared for superiority. Noninferiority tests were performed using the Farrington-Manning score test. Multivariate tests based on generalized estimating equations were performed to determine the common and average treatment effects. Odds ratios (OR) with 95% confidence intervals (CI) were calculated. RESULTS The LB cohort demonstrated lower pain scores [postoperative day 1 (POD 1)-median=2, interquartile range (IQR)=(0-5) vs. 5 (2.5-7); POD 2-3 (0-5) vs. 4 (3-6); P<0.001], lower overall opioid consumption (78.2 vs. 129 morphine milligram equivalents; P=0.0001) and consistently from POD 0 to 3 (mean differences; 7.47, 9.04, 17.2, and 17.3 morphine milligram equivalents, respectively; P<0.01), shorter LOS (median=3 d, IQR=3-4 vs. 4 d, IQR=4-6; P<0.001), and similar to-home DD (98% vs. 97%). Complications were similar among the cohorts in superiority and 10% noninferiority analyses. Patients in the LB cohort had lower odds for complications (odds ratio=0.77; 95% CI, 0.64-0.93; P=0.009 and 0.67; 95% CI, 0.50-0.90; P=0.008). CONCLUSIONS This study demonstrated the safety and efficacy of LB when added to the current multimodal postoperative pain management regimens after pediatric spinal surgery. LEVEL OF EVIDENCE Level III.

Liposomal Bupivacaine Is Both Safe and Effective in Controlling Postoperative Pain After Spinal Surgery in Children: A Controlled Cohort Study.

Background Intravenous (IV) levetiracetam (LEV) is an antiseizure medication traditionally given as an intermittent infusion to mitigate potential adverse effects given its acidic formulation. The process of compounding may lead to delays in treating status epilepticus, which is why administration of undiluted doses is of interest. Prior studies have shown safety of IV doses from 1000 mg to 4500 mg; however, assessments of adverse side effects outside IV site reactions have not been studied. Methods A retrospective analysis was completed with patients who received 1500 mg doses of undiluted IV LEV. We included patients ≥ 18 years old that received at least 1 dose of IV LEV 1500 mg from January 2018 to February 2021. Study end points included assessment of hemodynamic disturbance (bradycardia [HR less than 50 beats per minute] or hypotension [SBP less than 90 mmHg] within 1 hour or documented infusion reaction within 12 hours of LEV. Descriptive statistics were utilized. Results A total 213 doses of 1500 mg of IV LEV were administered to 107 patients. Peripheral lines were used for 85.9% of doses. Approximately half of doses (57) were administered to patients on the general wards, with the remainder in the intensive care unit or emergency department. Two patients (1.9%) experienced bradycardia; however, 1 patient had pre-existing bradycardia. Three patients (3.8%) experienced hypotension; however, those patients were receiving vasopressors prior to the dose. There were no cases of infusion reaction. Conclusion Undiluted, rapid administration of IV LEV 1500 mg was well tolerated and safe.

Evaluation of the Safety of Rapid Administration of Undiluted High-Dose Intravenous Levetiracetam

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Liposomal Bupivacaine Is Both Safe and Effective in Controlling Postoperative Pain After Spinal Surgery in Children: A Controlled Cohort Study.

Evaluation of the Safety of Rapid Administration of Undiluted High-Dose Intravenous Levetiracetam