BrAIST-Calc: Prediction of Individualized Benefit From Bracing for Adolescent Idiopathic Scoliosis.

STUDY DESIGN: Prospective multicenter study data were used for model derivation and externally validated using retrospective cohort data. OBJECTIVE: Derive and validate a prognostic model of benefit from bracing for adolescent idiopathic scoliosis (AIS). SUMMARY OF BACKGROUND DATA: The Bracing in Adolescent Idiopathic Scoliosis Trial (BrAIST) demonstrated the superiority of bracing over observation to prevent curve progression to the surgical threshold; 42% of untreated subjects had a good outcome, and 28% progressed to the surgical threshold despite bracing, likely due to poor adherence. To avoid over-treatment and to promote patient goal setting and adherence, bracing decisions (who and how much) should be based on physician and patient discussions informed by individual-level data from high-quality predictive models. MATERIALS AND METHODS: Logistic regression was used to predict curve progression to <45° at skeletal maturity (good prognosis) in 269 BrAIST subjects who were observed or braced. Predictors included age, sex, body mass index, Risser stage, Cobb angle, curve pattern, and treatment characteristics (hours of brace wear and in-brace correction). Internal and external validity were evaluated using jackknifed samples of the BrAIST data set and an independent cohort (n=299) through estimates of discrimination and calibration. RESULTS: The final model included age, sex, body mass index, Risser stage, Cobb angle, and hours of brace wear per day. The model demonstrated strong discrimination ( c -statistics 0.83-0.87) and calibration in all data sets. Classifying patients as low risk (high probability of a good prognosis) at the probability cut point of 70% resulted in a specificity of 92% and a positive predictive value of 89%. CONCLUSION: This externally validated model can be used by clinicians and families to make informed, individualized decisions about when and how much to brace to avoid progression to surgery. If widely adopted, this model could decrease overbracing of AIS, improve adherence, and, most importantly, decrease the likelihood of spinal fusion in this population.

Variability in evaluation and treatment of tibial tubercle fractures among pediatric orthopedic surgeons.

The purpose of this study was to determine the variability in clinical management of tibial tubercle fractures among a group of pediatric orthopedic surgeons. Nine fellowship-trained academic pediatric orthopedic surgeons reviewed 51 anteroposterior and lateral knee radiographs with associated case age. Respondents were asked to describe each fracture using the Ogden classification (type 1-5 with A/B modifiers), desired radiographic workup, operative vs. nonoperative treatment strategy and plans for post-treatment follow-up. Fair agreement was reached when classifying the fracture type using the Ogden classification (k = 0.39; P < 0.001). Overall, surgeons had a moderate agreement on whether to treat the fractures operatively vs. nonoperatively (k = 0.51; P < 0.001). Nonoperative management was selected for 80.4% (45/56) of type 1A fractures. Respondents selected operative treatment for 75% (30/40) of type 1B, 58.3% (14/24) of type 2A, 97.4% (74/76) of type 2B, 90.7% (39/43) of type 3A, 96.3% (79/82) of type 3B, 71.9% (87/121) of type 4 and 94.1% (16/17) of type 5 fractures. Regarding operative treatment, fair/slight agreement was reached when selecting the specifics of operative treatment including surgical fixation technique (k = 0.25; P < 0.001), screw type (k = 0.26; P < 0.001), screw size (k = 0.08; P < 0.001), use of washers (k = 0.21; P < 0.001) and performing a prophylactic anterior compartment fasciotomy (k = 0.20; P < 0.001). Furthermore, surgeons had fair/moderate agreement regarding the specifics of nonoperative treatment including degree of knee extension during immobilization (k = 0.46; P < 0.001), length of immobilization (k = 0.34; P < 0.001), post-treatment weight bearing status (k = 0.30; P < 0.001) and post-treatment rehabilitation (k = 0.34; P < 0.001). Significant variability exists between surgeons when evaluating and treating pediatric tibial tubercle fractures.

Application of a Halo Fixator for the Treatment of Pediatric Spinal Deformity.

BACKGROUND: In spine surgery, the halo fixator was initially utilized to stabilize cervical fusions in patients with poliomyelitis. More recently, the indications for halo fixation have evolved to include stabilization and definitive treatment for upper cervical spine injuries (Jefferson fractures, atlanto-occipital dissociations, odontoid fractures, etc.), treatment of atlantoaxial rotatory subluxation, stabilization of long cervical fusions, and preoperative traction. In the realm of pediatric spinal deformity, halo fixation has proved to be a valuable resource for severe or neglected spinal deformities. In this video article, we demonstrate the application of a halo fixator in a pediatric patient with severe scoliosis. DESCRIPTION: The procedure includes appropriate pin placement in the safe zones of the skull performed under either general anesthesia or local anesthesia. Pins are secured to a halo frame that is sized to be 2 cm larger than the circumference of the skull and are tightened according to age-specific torque guidelines. ALTERNATIVES: Alternative treatments vary from cervical spine immobilization to definitive surgical treatment in the spine, or even spinal osteotomies, depending on the underlying spinal pathology. RATIONALE: The halo fixator works by limiting motion of the cervical spine in flexion, extension, and axial rotation. The halo is also able to control and correct translational injuries of the cervical spine. In the setting of spinal deformity, the halo fixator can also be utilized to overcome the effects of gravity and lengthen the spine. EXPECTED OUTCOMES: For spinal deformities, the halo fixator can be expected to lengthen the spine and increase deformity flexibility prior to definitive surgical treatment in the spine or growth-friendly spinal instrumentation. IMPORTANT TIPS: Correct identification of safe zones for pin placement is vital to correct pin placement.For pediatric patients, it is important to obtain fixation with a minimum of 6 to 8 pins.Pins should be tightened with use of a torque-limiting wrench, up to no more than 1 in/lb (55.9 mm/kg) per year of age, up to a maximum of 8 in/lb (447.9 mm/kg).Applied traction should be a maximum of 50% of the body weight of the patient.Neurovascular examination is vital following application of weight.

In-hospital opioid usage following posterior spinal fusion for adolescent idiopathic scoliosis: Does methadone offer an advantage when used with an ERAS pathway?

PURPOSE: Intraoperative methadone has been shown to decrease opioid medication requirement following posterior spinal fusion (PSF) for adolescent idiopathic scoliosis (AIS). No study to date has investigated the effect of methadone on opioid medication requirement when used in conjunction with an enhanced recovery after surgery (ERAS) protocol following PSF. METHODS: A retrospective cohort study was performed at a single, tertiary care pediatric hospital. Patients with AIS undergoing PSF were consecutively given a single intra-operative methadone dose and matched 1:2 to a AIS control group without methadone. Patients were matched for age, curve magnitude, levels fused, blood loss, and operating time. All children followed a standard ERAS protocol with methadone being the only change in the post-operative regimen. In-hospital data for opioid and non-opioid medication use, surgical, and patient variables were recorded and compared between cohorts. RESULTS: Twenty-six patients received methadone (average 15.1 ± 1.9 years) and were matched with 52 control patients without methadone (average 14.7 ± 2.2 years). There were no significant differences in total opioid usage at any time-interval prior to hospital discharge or in cumulative opioid usage. Additionally, patients had a similar VAS pain level at discharge (methadone: 4.0 ± 2.3 vs control: 3.8 ± 1.9; P = 0.572). Total opioid usage was correlated with LOS. There were no opioid-related medication complications in either cohort. CONCLUSION: There was no decrease of in-hospital opioid usage when methadone was used with an ERAS protocol. Total opioid usage is correlated with hospital LOS following PSF.

Chronic intercostal neuralgia after placement of right ventricle to pulmonary artery conduit with prosthetic valve.

Adults with congenital heart disease often have complex medical issues requiring individualised multidisciplinary care for optimising outcomes and quality of life. Chronic pain is an example. We report a rare case of intercostal neuralgia seemingly caused by irritation from a prosthetic valve in a right ventricle to pulmonary artery conduit in a patient with tetralogy of Fallot. Intercostal neuralgia is a painful disorder linked to nerve irritation or injury from trauma, infection or pressure. Although chronic postsurgical pain after cardiac surgery is prevalent, rarely the aetiology relates to valve irritation on a single intercostal nerve. After failing pharmacological therapy for 8 months, the neuralgia completely resolved after an ultrasound-guided neurolytic block with long-term effectiveness and improvement in patient satisfaction.

Particle Filtration Efficiency Testing of Sterilization Wrap Masks.

OBJECTIVES: Non-traditional materials are used for mask construction to address personal protective equipment shortages during the coronavirus disease 2019 (COVID-19) pandemic. Reusable masks made from surgical sterilization wrap represent such an innovative approach with social media frequently referring to them as "N95 alternatives." This material was tested for particle filtration efficiency and breathability to clarify what role they might have in infection prevention and control. METHODS: A heavyweight, double layer sterilization wrap was tested when new and after 2, 4, 6, and 10 autoclave sterilizing cycles and compared with an approved N95 respirator and a surgical mask via testing procedures using a sodium chloride aerosol for N95 efficiency testing similar to 42 CFR 84.181. Pressure testing to indicate breathability was also conducted. RESULTS: The particle filtration efficiency for the sterilization wrap ranged between 58% to 66%, with similar performance when new and after sterilizing cycles. The N95 respirator and surgical mask performed at 95% and 68% respectively. Pressure drops for the sterilization wrap, N95 and surgical mask were 10.4 mmH2O, 5.9 mmH2O, and 5.1 mmH2O, respectively, well below the National Institute for Occupational Safety and Health limits of 35 mmH2O during initial inhalation and 25 mmH2O during initial exhalation. CONCLUSIONS: The sterilization wrap's particle filtration efficiency is much lower than a N95 respirator, but falls within the range of a surgical mask, with acceptable breathability. Performance testing of non-traditional mask materials is crucial to determine potential protection efficacy and for correcting misinterpretation propagated through popular media.

Short term outcomes of an enhanced recovery after surgery (ERAS) pathway versus a traditional discharge pathway after posterior spinal fusion for adolescent idiopathic scoliosis.

PURPOSE: Enhanced Recovery after Surgery (ERAS) pathways have been shown to decrease length of stay (LOS) after posterior spinal fusion (PSF) for adolescent idiopathic scoliosis (AIS). The aim of this study was to compare immediate post-operative outcomes following an ERAS pathway with a traditional pathway for AIS. METHODS: A prospective dual-center study of patients treated using an ERAS pathway (203 patients) or a traditional discharge (TD) pathway (73 patients) was performed with focus on pain at discharge, quality of life at one month, and return to school/work. RESULTS: LOS was 55% less in the ERAS group (4.8 days TD vs. 2.2 days ERAS, p < 0.001). Length of surgery (4.8 h TD vs. 2.8 h, p < 0.001) and EBL (500 cc vs. 240 cc, p < 0.001) were greater in the TD group, likely related to larger curve magnitudes ((62.0° TD vs. 54.0° ERAS, p < 0.001), a higher percentage of patients undergoing osteotomies (94% vs. 46%, p < 0.001) and more levels fused (11.4 ± 1.6 vs. 10.1 ± 2.6, p < 0.001) in the TD group. Regression analysis showed no difference in Visual Analog Score (VAS) score at discharge or quality of recovery using the QOR9 instrument between groups at follow up. There was no difference in return to school (p = 0.43) and parents' return to work (p = 0.61) between the groups. CONCLUSION: Patients managed with an ERAS pathway had similar pain scores at discharge than those managed with a TD pathway. Both groups showed evidence of rapid return to normalcy by the first follow up visit.

Pharmacokinetics and Optimal Dose Selection of Cefazolin for Surgical Prophylaxis of Pediatric Patients.

Cefazolin is an antibiotic frequently used for perioperative prophylaxis. Data from healthy adults and pediatric surgery patients were pooled to refine a previously developed population pharmacokinetic (PK) model and to determine the optimal body weight cutoff for selecting fixed doses of either 1 or 2 g cefazolin to produce exposures in pediatric surgery patients similar to a single 2-g dose in adults. Regardless of dose used, cefazolin was well tolerated in pediatric patients. A total of 1102 plasma samples from 62 patients from 3 studies were available to assess the previous model. The pooled data set allowed for simplification of the model such that allometrically scaled clearance and volume parameters were found to provide a robust fit while removing unnecessary covariate relationships. Monte Carlo simulations using the final cefazolin population PK model suggested an optimal weight cutoff of 50 kg, in contrast to the previously suggested 60 kg for a single 2-g dose. Patients at or above this 50-kg cutoff would receive a 2-g dose of cefazolin, and those below 50 kg but ≥25 kg would receive a 1-g dose of cefazolin.

Are precontoured cobalt-chromium spinal rods mechanically superior to manually contoured rods?

STUDY DESIGN: Laboratory based study. OBJECTIVE: To compare reduction force and plastic deformation of cobalt-chromium (Co-Cr) spinal rods using a rigid, thoracolumbar spinal deformity model. Pre-contoured spinal rods are growing in their utilization for spinal deformity. Although there are theoretical advantages to pre-contouring rods, no previous studies have compared pre-contoured and manually contoured rods for their ability to maintain sagittal contour and resist mechanical load. METHODS: A spinal deformity model was utilized, simulating a rigid, thoracolumbar spinal deformity fixated with pedicle screws. Roll-formed pre-contoured and manually contoured 5.5 mm and 6.0 mm Co-Cr rods were reduced to the model with a load cell attached to the apical screw to measure corrective force. Rods remained reduced in the model for 20 min and change in contour was assessed to characterize plastic deformation. RESULTS: Twenty-four rods were tested with six rods per group (Table 1). The load to reduction was significantly lower in the 5.5 mm rods compared to the 6.0 mm rods (95% CI -254.0 to -61.42; p = 0.008). Although there was no difference in the corrective forces for manual and pre-contoured 5.5 mm rods (p = 0.722), the 6.0 mm rod produced significantly less corrective force compared to the manually contoured 6.0 mm rods (95% CI -134.42 to -5.317; p = 0.039). Additionally, rod contour for the manual group showed significantly less plastic deformation than the pre-contoured group in both 5.5 mm and 6.0 mm rods (5.5 mm: 57.1% vs. 61.6%, p = 0.006; 6.0 mm: 54.3% vs. 62.28%, p = 0.003). CONCLUSIONS: Roll formed, pre-contoured Co-Cr rods demonstrated significantly greater plastic deformation when compared with manually contoured rods of the same diameter. Furthermore, 6.0 mm pre-contoured rods required significantly lower load for rod reduction, the equivalent of 15 lb-force. Post-manufacturing, roll-formed pre-contouring of larger diameter Co-Cr may impair the rods mechanical properties.

Magnetically controlled growing instrumentation for early onset scoliosis: Caution needed when interpreting the literature.

BACKGROUND: Magnetically controlled growing rods (MCGR) are a novel treatment option for early onset scoliosis (EOS). Although the complication profile with MCGR use has been reviewed, these reviews do not take into account important implants modifications, termed iterations, that were made due to early on postoperative complications is not well reported or understood. AIM: To assess the effect of MCGR implant iterations on post-operative complications in EOS. METHODS: A systematic review was performed to identify studies investigating MCGR specifically for the treatment of EOS, refined to those reporting the implant iteration, specifically the incorporation of the keeper plate to the implant design. Articles with mixed implant iteration usage were excluded. Complications following surgery were recorded as well as potential risk factors and compared between implant cohorts. RESULTS: Although 20 articles were identified for inclusion, 5 included mixed implant iteration leaving a total of 271 patients identified through 15 clinical studies that met inclusion criteria. The average follow-up was 25.4-mo. Pre-keeper plate implants were utilized in 3 studies with a total of 49 patients. Overall, 115 (42.4%) post-operative complications were identified, with 87% defined as major. The addition of the keeper plate significantly decreased the rate of post-operative complications per study (35.7% vs 80.6%, P = 0.036), and the rate of distraction failure (8.1% vs 40.8%, P = 0.02). Unplanned reoperation occurred in 69 (26.7%) patients but was not different between implant iteration cohorts (25.5% without keeper plate vs 27.1% with keeper plate, P = 0.92). CONCLUSION: MCGR for EOS has a cumulative complication rate of 42.4% but this is significantly reduced to 35.7% when reviewing only keeper-plate enabled implants. However, 25% of published articles included mixed implant iterations. Future studies should discern between implants iterations when reporting on the usage of MCGR for EOS.

Spectrum of Off-Label Nitric Oxide Utilization After Pediatric Cardiac Surgery Among Centers of Varying Surgical Volume.

OBJECTIVE: Nitric oxide is utilized after pediatric cardiac surgery as an off-label medication without much evidence, is expensive, and varies among centers of varying surgical volume. The objective of our study was to describe the spectrum of nitric oxide utilization and to evaluate the effect of nitric oxide utilization on outcomes among patients cared for in centers of varying surgical volume using Pediatric Health Information system. METHODS: Patients aged ≤18 years undergoing heart surgery were included (2004-2015). Multivariable mixed-effects logistic regression models were fitted to evaluate association of center volume with odds of nitric oxide utilization among patients undergoing heart operations. Centers were classified into 3 volume categories based on tertiles of number of cardiopulmonary bypass cases performed (low volume: 34 792 patients, 21 centers; medium volume: 38 362 patients, 13 centers; high volume: 30 560 patients, 7 centers). RESULTS: A total of 103 714 patients from 41 hospitals were included. Of these, 15 708 (15.1%) patients received nitric oxide after cardiac surgery. Of the patients receiving nitric oxide, only 3936 (25.1%) patients were associated with a diagnosis of pulmonary hypertension. In adjusted models, low- and medium-volume centers were associated with higher nitric oxide utilization after heart operations as compared to high-volume centers (low vs high, odds ratio [OR]: 1.48, 95% confidence interval [CI]: 1.38-1.60; medium vs high, OR: 1.33, 95% CI: 1.26-1.41). Despite higher nitric oxide utilization, the mortality was worse among patients treated in low- and medium-volume centers, as compared to high-volume centers (low vs high, OR: 1.42, 95% CI: 1.26-1.60; medium vs high, OR: 1.14, 95% CI: 1.04-1.25). CONCLUSIONS: This study demonstrates variation in nitric oxide utilization after heart operations among centers of varying surgical volume. Further, it raises questions on the benefit of nitric oxide administration after pediatric cardiac surgery.

Nighttime bracing with the Providence thoracolumbosacral orthosis for treatment of adolescent idiopathic scoliosis: A retrospective consecutive clinical series.

BACKGROUND:: Orthotic treatment for adolescent idiopathic scoliosis is a mainstay in nonoperative treatment to prevent progressive spinal deformity. OBJECTIVE:: To determine the effectiveness of the Providence orthosis in the treatment of adolescent idiopathic scoliosis. STUDY DESIGN:: Retrospective review. METHODS:: Patients treated with a Providence orthosis for adolescent idiopathic scoliosis were reviewed. Inclusion criteria included the following: age of 10-18 years; curve magnitude of 25°-40°; Risser stage of 0-2; and, if female, <1 year post menarche at the time of brace initiation. Failure was defined as curve magnitudes progressing >5° or to >45° or surgery. Radiographs and clinical information were recorded and compared between treatment success and failure cohorts. RESULTS:: 56 patients (51 female and 5 male; average of 12.26 years) were identified with average of 2.21-year follow-up and a 57.1% success rate for preventing curve progression. Factors associated with successful treatment included curve apex T10 and caudal and Risser sign ⩾ 1. Multivariate analysis identified Risser ⩾ 1 and curve apex T10 and caudal as independent predictors of successful treatment. CONCLUSION:: The Providence nighttime orthosis can be an effective treatment for adolescent idiopathic scoliosis. Curve Apex at T10 or caudal was an independent predictors of treatment success. CLINICAL RELEVANCE: This study identifies variables associated with treatment success using the Providence nighttime orthosis in a consecutive series of adolescent idiopathic scoliosis patients. This information provides the foundation for identifying ideal patients for nighttime bracing to guide clinical treatment.

Incidence of Immediate Extubation After Pediatric Cardiac Surgery and Predictors for Reintubation.

OBJECTIVES: The objectives were to assess the incidence of immediate tracheal extubation in the operating room after pediatric cardiac surgery and to investigate predictors for subsequent reintubation. METHODS: This is a single institutional retrospective study including all patients who had a cardiac operation with cardiopulmonary bypass from 2011 to 2016. Patients who required preoperative ventilator support, postoperative open chest, or mechanical support were excluded. Predictors for reintubation after immediate extubation were analyzed only for patients with stage II palliation for single ventricle physiology. RESULTS: Nine hundred nine qualifying operations were identified. Immediate extubation was performed in 590 (64.9%) operations. A multivariable logistic regression model showed that the identities of anesthesiologist ( P = .0003), year of the operation performed ( P < .001), cardiopulmonary bypass time ( P < .001), and type of operations ( P < .001) were significantly associated with immediate extubation. Reintubation was significantly less frequent in patients with immediate extubation compared to those without (6.1% vs 15.0%; P < .001). A subgroup analysis for stage II palliation showed that reintubation after immediate extubation was significant for younger age (0.42 vs 0.54 years, P = .044), lower Po2/Fio2 and Po2 at the last blood gas analysis (66 vs 98 mm Hg, P = .032 and 39 vs 47 mm Hg, P = .008), and higher inotropic score (2 vs 0, P = .034). A multivariable logistic regression model showed that only inotropic score was significantly associated with reintubation ( P = .018). CONCLUSIONS: Immediate extubation in the operating room after pediatric cardiac surgery can be performed in most patients. Inotropic score is a predictor for reintubation in stage II palliation.

Intraocular pressure in children after congenital heart surgery: A single-center study.

BACKGROUND: The impact of varied cardiac physiologies on intraocular pressure (IOP) among children undergoing heart operations is unknown. AIM: The aim of this study was to determine the IOP among children with varying cardiovascular physiologies and varying hemodynamics after their heart operation. SETTING AND DESIGN: This was a prospective, observational study. MATERIALS AND METHODS: Patients ≤18 years undergoing congenital heart surgery were included in this study. IOP measurement was performed by Icare® tonometer between 3 and 14 days after heart operation. STATISTICAL ANALYSIS: Summary statistics were estimated for all demographic, anthropometric, and clinical data. RESULTS: A total of 116 eyes from 58 children were included. The mean and standard deviation age was 28.4 (45.8) months. Single-ventricle anatomy was present in 26 patients (45%). Despite similar heart rate and blood pressure, the mean IOP among the patients with single-ventricle anatomy was significantly elevated as compared to patients with two-ventricle anatomy (18 mm Hg vs. 12 mm Hg, P < 0.001). There was no difference in IOP measurements based on the complexity of operation performed. We noted that patients undergoing surgical palliation with central shunt (21 mm Hg), Fontan operation (19 mm Hg), bidirectional Glenn operation (19 mm Hg), Norwood operation (19 mm Hg), or definitive repairs such as tetralogy of Fallot repair (17 mm Hg), and atrioventricular canal repair (19 mm Hg) were associated with the highest IOPs in the study cohort. CONCLUSIONS: This study demonstrates that IOPs vary with varying cardiovascular physiology after pediatric cardiac surgery.

Peri-procedural risk stratification and management of patients with Williams syndrome.

Williams syndrome (WS) is a congenital, multisystem disorder affecting the cardiovascular, connective tissue, and central nervous systems in 1 in 10 000 live births. Cardiovascular involvement is the most common cause of morbidity and mortality in patients with WS, and noninvasive and invasive procedures are common. Sudden cardiovascular collapse in patients with WS is a well-known phenomenon, especially in the peri-procedural period. Detailed guidelines for peri-procedural management of patients with WS are limited. The goal of this review is to provide thoughtful, safe and effective management strategies for the peri-procedural care of patients with WS with careful consideration of hemodynamic impacts of anesthetic strategies. In addition, an expanded risk stratification system for anesthetic administration is provided.

Is Administration of Nitric Oxide During Extracorporeal Membrane Oxygenation Associated With Improved Patient Survival?

OBJECTIVE: To evaluate the outcomes associated with the use of inhaled nitric oxide during extracorporeal membrane oxygenation. DESIGN: Post hoc analysis of data from an existing administrative national database, Pediatric Health Information system (2004-2014). Multivariable logistic regression models were fitted to study the effect of inhaled nitric oxide during extracorporeal membrane oxygenation on study outcomes. SETTING: Forty-two children's hospitals across the United States. PATIENTS: Patients in the age group from 1 day through 18 years admitted to an ICU who received extracorporeal membrane oxygenation during their hospital stay were included. INTERVENTIONS: None. MEASUREMENTS AND MAIN RESULTS: In total, 6,419 patients qualified for inclusion. Of these, inhaled nitric oxide was used among 3,629 patients during extracorporeal membrane oxygenation run. Approximately one half of the study patients received inhaled nitric oxide at extracorporeal membrane oxygenation initiation. The proportion of patients receiving inhaled nitric oxide during extracorporeal membrane oxygenation decreased with increasing duration of extracorporeal membrane oxygenation. After adjusting for patient characteristics and center variables, use of inhaled nitric oxide was not associated with any survival benefit. However, higher proportion of patients receiving inhaled nitric oxide were associated with prolonged hospital length of stay and prolonged duration of extracorporeal membrane oxygenation. In adjusted models, the hospital charges were higher in the inhaled nitric oxide group. The median hospital costs among patients receiving inhaled nitric oxide were higher by $39,732 (95% CI, $31,074-48,390) as compared to the patients who did not receive inhaled nitric oxide, after adjusting for patient (including hospital length of stay) and center level variables. As the duration of inhaled nitric oxide therapy increased, proportion of patients with prolonged duration of extracorporeal membrane oxygenation and prolonged hospital length of stay increased. CONCLUSIONS: This large observational analysis of use of nitric oxide during extracorporeal membrane oxygenation calls into question the benefits of inhaled nitric oxide among patients receiving extracorporeal membrane oxygenation for pulmonary or cardiac failure. Given our inability to determine type of extracorporeal membrane oxygenation and control for severity of illness, these findings should be interpreted as exploratory.

Chronic Foot Pain due to Pachyonychia Congenita in a Pediatric Patient: A Successful Management Strategy.

We report the case of an 11-year-old girl who presented to our multidisciplinary pain center with the chief complaint of chronic bilateral foot pain because of a rare congenital keratin disorder. This patient had been diagnosed with pachyonychia congenita, an extremely rare genetic disorder primarily affecting the skin and nails. The child had bilateral foot pain for years because of the characteristic blisters and calluses on the soles of her feet. Chronic pain was negatively impacting her quality of life; she was severely limited in her activities of daily living secondary to pain. Furthermore, she reported absenteeism from school, lack of social activities, and frequent nighttime awakenings. We discuss the successful management of her chronic foot pain using a multimodal, multidisciplinary approach.

Safety and Efficacy of Needle-free Powder Lidocaine Delivery System in Adult Patients Undergoing Venipuncture or Peripheral Venous Cannulation: A Randomized, Double-Blind, Placebo-controlled Trial.

OBJECTIVES: The purpose of this study was to evaluate the efficacy, safety, and tolerability of a needle-free powder lidocaine delivery system compared with sham placebo in adults. METHODS: Adult patients participated in this multicenter, randomized, double-blind, placebo-controlled, parallel-group study. Patients were randomly allocated to receive either the needle-free powder lidocaine delivery system or sham placebo 1 to 3 minutes before a required venipuncture or venous cannulation. The primary efficacy endpoint measured the analgesic effect of the active system using a pain visual analogue scale. RESULTS: In 693 adults who completed the study, the needle-free powder lidocaine delivery system was associated with significantly less pain during venipuncture and venous cannulation compared with sham placebo, as demonstrated by a difference between groups in age-adjusted mean pain score (P=0.003). Secondary analyses demonstrating significant differences between groups included the proportion of patients who were pain free, the proportion of responders, and the difference between pain experienced during the current venous procedure compared with the recollection of pain experienced during a prior venous procedure. Use of the active system was not associated with any serious adverse events or any adverse events resulting in study discontinuation. All treatment-related adverse events were mild. DISCUSSION: This clinical trial demonstrated that use of a needle-free powder lidocaine delivery system resulted in a significant reduction of pain during venipuncture and peripheral intravenous cannulation in adults. Both the predefined primary endpoint and all 3 secondary endpoints were met. The needle-free powder lidocaine delivery system may be an option for analgesia during venous access procedures in adults.

Safety and Efficacy of a Needle-free Powder Lidocaine Delivery System in Pediatric Patients Undergoing Venipuncture or Peripheral Venous Cannulation: Randomized Double-blind COMFORT-004 Trial.

PURPOSE: The goal of this study was to determine if a lidocaine hydrochloride monohydrate powder intradermal system designed to provide cutaneous analgesia is efficacious, safe, and tolerable for pediatric subjects compared with a sham placebo system. METHODS: COMFORT-004, A Phase III, Randomized, Double-Blind, Placebo-Controlled Study to Confirm the Effectiveness and Safety of ALGRX 3268 in Pediatric Subjects, was a single-dose, parallel group study of children undergoing venipuncture or peripheral venous cannulation at the antecubital fossa or back of the hand. Included were subjects (3-18 years) in 3 age groups: 3-7, 8-12, and 13-18 years. Excluded were those with recent similar procedures or with implantable devices or skin pathologies at the anatomical site, insufficient cognitive skills, or allergies to local anesthetics or adhesives. Subjects were randomized to receive the needle-free powder lidocaine delivery system (active system, 0.5 mg of lidocaine/21 ± 1 bar of pressure [n = 269]) or sham placebo (n = 266) 1-3 minutes before venipuncture or peripheral venous cannulation. Analgesic efficacy was assessed patient self-report of venous access pain (Wong-Baker FACES Pain Rating Scale [3-18 years] and visual analog scale [VAS; 8-18 years]) and parental observational VAS. Safety assessments included adverse events (AEs) and relationship to study treatment. Skin signs and symptoms were graded numerically. Wong-Baker FACES scores, VAS, and parental VAS were analyzed by using an ANOVA model. Responder ratings and success rates were compared by using a Cochran-Mantel-Haenszel test stratified according to center, age group, and body site. FINDINGS: The active system group had significantly (P = 0.0022) less pain compared with the sham placebo in all age groups combined according to the modified Wong-Baker FACES scale. Secondary efficacy analyses found that the active system resulted in less pain as assessed by subjects' VAS pain assessments aged 8-18 years (P = 0.1856), responder analysis (P = 0.054), and parents' VAS assessments (P = 0.002). Venous procedures were successful in 95.5% and 96.2% of the active system and sham placebo groups, respectively. Treatment-emergent AEs, most commonly nausea and/or emesis, were not significant between groups. There were no serious AEs. The active system group had significantly more minor erythema and hemorrhage/petechiae. IMPLICATIONS: The needle-free powder lidocaine delivery system was well tolerated and produced superior analgesia compared with sham placebo when administered 1-3 minutes before pediatric venipuncture or peripheral venous cannulation. Treatment-related AEs occurred primarily at the administration site and were infrequent, generally mild, and resolved without sequelae. ClinicalTrials.gov identifier: NCT00140088.

Congenital limb deficiency disorders.

Congenital limb deficiency disorders (LDDs) are birth defects characterized by the aplasia or hypoplasia of bones of the limbs. Limb deficiencies are classified as transverse, those due to intrauterine disruptions of previously normal limbs, or longitudinal, those that are isolated or associated with certain syndromes as well as chromosomal anomalies. Consultation with a medical geneticist is advisable. Long-term care should occur in a specialized limb deficiency center with expertise in orthopedics, prosthetics, and occupational and physical therapy and provide emotional support and contact with other families. With appropriate care, most children with LDDs can lead productive lives.