Antimicrobial Prophylaxis in Neonates and Children Undergoing Dental, Maxillo-Facial or Ear-Nose-Throat (ENT) Surgery: A RAND/UCLA Appropriateness Method Consensus Study

Surgical site infections (SSIs) represent a potential complication in surgical procedures, mainly because clean/contaminated surgery involves organs that are normally colonized by bacteria. Dental, maxillo-facial and ear-nose-throat (ENT) surgeries are among those that carry a risk of SSIs because the mouth and the first respiratory tracts are normally colonized by a bacterial flora. The aim of this consensus document was to provide clinicians with recommendations on surgical antimicrobial prophylaxis in neonates (<28 days of chronological age) and pediatric patients (within the age range of 29 days–18 years) undergoing dental, maxillo-facial or ENT surgical procedures. These included: (1) dental surgery; (2) maxilla-facial surgery following trauma with fracture; (3) temporo-mandibular surgery; (4) cleft palate and cleft lip repair; (5) ear surgery; (6) endoscopic paranasal cavity surgery and septoplasty; (7) clean head and neck surgery; (8) clean/contaminated head and neck surgery and (9) tonsillectomy and adenoidectomy. Due to the lack of pediatric data for the majority of dental, maxillo-facial and ENT surgeries and the fact that the recommendations for adults are currently used, there is a need for ad hoc studies to be rapidly planned for the most deficient areas. This seems even more urgent for interventions such as those involving the first airways since the different composition of the respiratory microbiota in children compared to adults implies the possibility that surgical antibiotic prophylaxis schemes that are ideal for adults may not be equally effective in children

Nervous System and psychiatric disorders with ketamine (ab)use: an analysis of the WHO global individual case reports database (VigiBase)

Ketamine is an anaesthetic drug with dissociative, analgesic and psychedelic properties. The dissociative experience is pleasurable to some and has led to ketamine gaining in popularity as a recreational drug. Like all medicines, ketamine may have adverse drug reactions (ADRs). These can be spontaneously reported and then collected in an international database. The aim of study is to analyze reports in WHO Global Individual Case Safety Reports (ICSR) database (VigiBase)to understand in which cases ketamine was non-medical used and was abused

Profilo di sicurezza dose-dipendente della ketamina: analisi del database dell'OMS.

La ketamina \ue8 un farmaco anestetico il cui uso ricreazionale \ue8 aumentato nel corso degli anni. Recenti ricerche hanno inoltre dimostrato che la singola somministrazione di ketamina a dosaggio sub-anestetico induce un rapido effetto antidepressivo. Lo scopo dello studio \ue8 stato quello di caratterizzare il profilo di sicurezza dose-dipendente della ketamina soprattutto relativamente al suo utilizzo a basso dosaggio in modo da avere un riferimento per i futuri farmaci ketamina-like

Anaphylatic reactions to biological drugs:data from spontaneous reporting in Italy

Anaphylatic reactions to biological drugs:data from spontaneous reporting in Ital

Tamsulosin and gynecomastia: data from the Italian spontaneous reporting system

Background: Gynecomastia is caused by drugs in 10\u201325%of all cases.[1] It is defined histologically as a benign proliferation of the glandular tissue of the male breast and clinically by the presence of a rubbery or firm mass extending concentrically from the nipple(s). There are evidences of gynecomastia due to 5a-Reductase inhibitors as finasteride and dutasteride but there aren\u2019t available studies about gynecomastia associated with tamsulosin use in literature. To date, gynecomastia is not reported in the Summary Product Information (SPC) of the drug. Aim of this study is to evaluate the cases of gynecomastia tamsulosininduced in the Italian spontaneous reporting database (Rete Nazionale di FarmacoVigilanza - RNF). Methods: Adverse reaction are coded in the RNF using both MedDRA and WHO-ART. Cases of gynecomastia has been defined as reports associated to WHO-ART Preferred terms Gynaecomastia, Breast enlargement, Breast pain male, Breast pain and Breast discomfort. Results: Up to December 2011 about 132 800 reports are present in the RNF, excluding vaccines and reports from the literature. In the whole database 247 reports have been associated to tamsulosin, whereas in 699 reports tamsulosin has been reported as concomitant drug. Eight cases of gynecomastia associated to tamsulosin have been reported: two of these have also dutasteride as concomitant drug. Other 10 reports with gynecomastia have tamsulosin as concomitant drug. Eight of these have been associated to another 5a-reductase inhibitor (dutasteride or finasteride). Time of onset showed a great variability from 1 day to 4 years since the start of therapy. Among cases with tamsulosin as the only suspected drug, no information on laboratory analyses was available. A positive dechallenge has been reported in two cases. In the WHO database (Vigibase) 78 reports of gynecomastia in which tamsulosin is indicated as suspected/concomitant drug are present. These reports have been submitted by eleven different countries and tamsulosin is the only drug suspected in fifty of them. Conclusion: A high number of cases of gynecomastia in reports with tamsulosin are present in the RNF. Most of these reports have tamsulosin as concomitant drug or have also other 5a-reductase inhibitor leading to a difficult causality assessment. However, in six cases tamsulosin is the only reported drug suggesting an association to gynecomastia also for this drug. The combination tamsulosin-gynecomastia should probably be highlighted in product information

High-fat meal, systemic inflammation and glucose homeostasis in obese children and adolescents

We aimed to assess in obese youths the relationships between interleukin-6 (IL-6), fat meal-induced endotoxemia and glucose homeostasis. Twenty obese children/adolescents (9-17 years old, 11 boys) underwent a standard oral glucose tolerance test and, 7-14 days later, a 5-h fat meal test (fat=69% of energy, saturated/monounsaturated/polyunsaturated fatty acids=31.5%/35%/33.5%), with serial measures of IL-6 and two markers of lipopolysaccharide (LPS) exposure and translocation, LPS-binding protein (LBP) and soluble CD14 (sCD14). IL-6 correlated not only with basal (homeostatic model assessment-insulin resistance) but also with post-prandial (Matsuda index) insulin sensitivity (r=0.61 (0.24-0.82), P=0.005, r=-0.53 (0.12-0.78), P=0.03, respectively). IL-6 did not change after the meal whereas LBP and sCD14 decreased significantly, indicating LPS translocation. Neither basal sCD14 and LBP nor their incremental concentrations correlated with IL-6 or glucose homeostasis. In our sample, IL-6 was associated with insulin sensitivity but not with LPS exposure, suggesting that meals with a balanced content of saturated/monounsaturated/polyunsaturated fatty acids may not be associated with LPS-induced inflammation and metabolic impairment

Adding wisdom to ‘smart’ bioelectronic systems: a design framework for physiologic control including practical examples

This perspective provides an overview of how risk can be effectively considered in physiological control loops that strive for semi-to-fully automated operation. The perspective first introduces the motivation, user needs and framework for the design of a physiological closed-loop controller. Then, we discuss specific risk areas and use examples from historical medical devices to illustrate the key concepts. Finally, we provide a design overview of an adaptive bidirectional brain–machine interface, currently undergoing human clinical studies, to synthesize the design principles in an exemplar application

Chronic embedded cortico thalamic closed loop deep brain stimulation for the treatment of essential tremor

Deep brain stimulation (DBS) is an approved therapy for the treatment of medicallyrefractory and severe movement disorders. However, most existing neurostimulators can only apply continuous stimulation (open-loop DBS, OL-DBS), ignoring patient behavior and environmental factors, which consequently leads to an inefficient therapy, thus limiting the therapeutic window. Here, we established the feasibility of a self-adjusting therapeutic DBS (closed-loop DBS, CL-DBS), fully embedded in a chronic investigational neurostimulator (Activa PC+S), for 3 patients affected by essential tremor (ET) enrolled in a longitudinal (6 months) within-subject crossover protocol (DBS OFF, OL-DBS, CL-DBS). Most patients with ET experience involuntary limb tremor during goal-directed movements, but not during rest. Hence, the proposed CL-DBS paradigm explored the efficacy of modulating the stimulationamplitude based on patient-specific motor behavior, suppressing the pathological tremor ondemand based on a cortical electrode detecting upper-limb motor activity. Herein, we demonstrated how the proposed stimulation paradigm was able to achieve clinical efficacy and tremor suppression comparable with OL-DBS in a range of movements (cup reaching, proximal and distal posture, water pouring, writing), while having a consistent reduction in energy delivery. The proposed paradigm is an important step towards a behaviorally modulated fully embedded DBS system, capable of delivering stimulation only when needed, and potentially mitigating pitfalls of OL-DBS, such as DBS-induced side effects and premature device replacement