Pediatric Extrapolation Approach for U.S. Food and Drug Administration Approval of Brexpiprazole in Patients Aged 13 to 17 Years with Schizophrenia.

A pharmacokinetic (PK) bridging approach was successfully employed to support the dosing regimen and approval of brexpiprazole in pediatric patients aged 13-17 years with schizophrenia. Brexpiprazole was approved in 2015 for the treatment of schizophrenia and the adjunctive treatment of major depressive disorder in adults based on efficacy and safety data from clinical trials. On January 13, 2020, the US Food and Drug Administration issued a general advice letter to sponsors highlighting the acceptance of efficacy extrapolation of certain atypical antipsychotics from adult patients to pediatric patients considering the similarity in disease and exposure-response relationships.

Prevalence of prescription opioid use during pregnancy in eight US health plans during 2001-2014.

Purpose: To estimate prevalence of prescription opioid use during pregnancy in eight US health plans during 2001-2014.

Methods: We conducted a cohort study of singleton live birth deliveries. Maternal characteristics were ascertained from health plan and/or birth certificate data and opioids dispensed during pregnancy from health plan pharmacy records.

Postoperative Spica Cast Care: RN Comfort-Level Survey Score Improvement After a 30-Minute Educational Video.

Spica casts are utilized to immobilize young patients who have sustained femur fractures or who have undergone hip procedures/surgery. These casts typically need to stay in place for 4-6 weeks. Improper postoperative care can lead to unplanned, increased morbidity and sequelae.

A Rare Cause of Postoperative Abdominal Pain in a Spinal Fusion Patient.

We present the case of a 12-year-old girl who underwent an uncomplicated posterior spinal fusion with instrumentation for scoliosis and who later developed nausea, emesis, and abdominal pain. We discuss the epidemiology, prevalence, anatomic findings, symptoms, diagnostic tests, and clinical management, including nonsurgical and surgical therapies, of superior mesenteric artery syndrome (SMAS), a rare condition. Over a 2-week period, the patient developed an uncommon type of bowel obstruction likely related to her initial thin body habitus, correction of her deformity, and weight loss after surgery.

Orthopaedic clinical care model in a pediatric orthopaedic setting: outcomes of a 1: 1 model--orthopaedic surgeon and nurse practitioner.

Over the last 10 years, nurse practitioners have become an essential part of the multidisciplinary orthopaedic team within a Level 1 pediatric trauma hospital. This overview will outline the process used and noted results during the development of a new model of care for pediatric orthopaedic patients, in both the hospital setting and outpatient clinics. Data from a 12-month period was reviewed in an effort to show the benefits of establishing a 1:1 model utilizing an orthopaedic surgeon and nurse practitioner.

Proximal humerus fractures.

Proximal humerus fractures are among the most common fractures associated with osteoporosis. With an aging population, incidence of these fractures will only increase. The proximal humerus not only forms the lateral portion of the shoulder articulation but also has significant associations with musculoskeletal and neurovascular structures.

A retrospective quality improvement study of ketorolac use following spinal fusion in pediatric patients.

Background: There are studies and literature that support the claim that ketorolac use after spinal fusion in the adult population can increase the risk of pseudarthrosis, instrumentation failure, and/or nonunion. There is limited research when using ketorolac in the pediatric population, especially short-term use.

Methods: Chart review of 46 pediatric patients who had prior spinal fusions for scoliosis between July 2003 and August 2005.

Transdermal selegiline in patients receiving electroconvulsive therapy.

Background: Concurrent use of monoamine oxidase inhibitors (MAOIs) during a course of electroconvulsive therapy (ECT) is controversial.

Objective: In this report, the authors present outcomes of this concurrent treatment approach.

Method: The authors present two cases of patients taking the newest MAOI approved for depression, namely, transdermal selegiline, while receiving ECT.

Lawn mower injuries in pediatric patients.

Lawn mower injuries are painful, devastating, and life-altering. Pediatric patients who sustain these injuries suffer various forms of physical trauma. Some are minor, but many others are disfiguring or even fatal.

Concurrent use of methotrexate and acitretin revisited.

Background: According to Food and Drug Administration (FDA)-approved prescribing information, combination therapy with acitretin and methotrexate (MTX) is contraindicated. This is based on company data suggesting increased hepatotoxicity in patients who received concomitant methotrexate and etretinate, the prodrug of acitretin.

Methods: We reviewed the clinical data of 18 patients with psoriasis who received methotrexate and acitretin concurrently.

Use of wound V.A.C. therapy in pediatric patients with infected spinal wounds: a retrospective review.

Background: Deep wound infection in patients that have had a posterior spinal fusion for scoliosis is a major complication in pediatric spine surgery.

Purpose: To explore characteristics of pediatric patients who had a posterior spinal fusion with segmental spinal instrumentation and bone graft and subsequently developed deep spinal wound infections that were treated with wound vacuum-assisted closure (V.A.