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Medicating foster care children with psychotropic drugs : an examimation
Foster children, often being removed from neglectful or abusive homes, are one of the country's most vulnerable populations. With the often traumatic circumstances that define their early lives, it is no wonder studies show their tendency for more mental health conditions than other children. Facing these and other significant challenges surrounding foster care programs, state authorities, caseworkers, and parents, are given few options on appropriate treatments. These options often include prescribing heavy-duty psychotropic drugs such as antidepressants and, in some cases, even antipsychotics - drugs which have little research available supporting their use in children. This book examines the practice of medicating America's foster children with a focus on the financial and societal costs.
Book
Abuse of Minors in Clinical Studies
With the emergence of effective drugs and observed drug toxicities in babies, two mantras emerged: that children are therapeutic orphans, and that children are not small adults. US and EU laws demand pediatric studies as a condition for the approval of new drugs in adults. This is called \"Pediatric Drug Development\" (PDD). Although apparently reasonable, there are catches. Children are vulnerable at birth, but they grow and become bodily mature with puberty, well before coming of age. Minors are not another species. The 18th birthday, an administrative/ legal limit, does not correspond to a physiological change. Drugs treat the body, not the legal status. PDD results in pointless studies in bodily mature adolescents, and in exaggerated studies in younger minors. An originally well-intentioned concept results in thousands of questionable studies worldwide. This book draws attention to conflicts of interest and ethical dilemmas of PDD and questions its applicability for adolescents and minors that are no longer babies.
eBook
Pharmacology related to paediatric anaesthesia
A child is not a mini adult. They differ from adults in terms of weight, shape, anatomical size and major body systems such as cardiovascular and respiratory as well as psychologically. Each organ system is immature in paediatric age group and their growth and development can dramatically affect the pharmacokinetics of different drugs. Children differ in every way from an adult thus mandating to have a basic knowledge of the pharmacokinetic and pharmacodynamic principles in paediatric population to prevent under dosing or toxicity of drugs. This review article aims to simplify the basic principles of pharmacokinetics and pharmacodynamics in paediatric population. It also highlights physiological and pharmacological differences between adults and paediatric age. We performed a PUBMED search for English language articles using keywords including pharmacology, child, paediatric anaesthesia. We also hand searched references from relevant review articles and text book chapters. We have also discussed drug interaction in anaesthesia, pharmacology pertaining to neuromuscular junction and effects of anaesthesia over the developing brain.
Journal Article
Pain and sedation management and monitoring in pediatric intensive care units across Europe: an ESPNIC survey
Background
Management and monitoring of pain and sedation to reduce discomfort as well as side effects, such as over- and under-sedation, withdrawal syndrome and delirium, is an integral part of pediatric intensive care practice. However, the current state of management and monitoring of analgosedation across European pediatric intensive care units (PICUs) remains unknown. The aim of this survey was to describe current practices across European PICUs regarding the management and monitoring of pain and sedation.
Methods
An online survey was distributed among 357 European PICUs assessing demographic features, drug choices and dosing, as well as usage of instruments for monitoring pain and sedation. We also compared low- and high-volume PICUs practices. Responses were collected from January to April 2021.
Results
A total of 215 (60% response rate) PICUs from 27 European countries responded. Seventy-one percent of PICUs stated to use protocols for analgosedation management, more frequently in low-volume PICUs (77% vs 63%,
p
= 0.028). First-choice drug combination was an opioid with a benzodiazepine, namely fentanyl (51%) and midazolam (71%) being the preferred drugs. The starting doses differed between PICUs from 0.1 to 5 mcg/kg/h for fentanyl, and 0.01 to 0.5 mg/kg/h for midazolam. Daily assessment and documentation for pain (81%) and sedation (87%) was reported by most of the PICUs, using the preferred validated FLACC scale (54%) and the COMFORT Behavioural scale (48%), respectively. Both analgesia and sedation were mainly monitored by nurses (92% and 84%, respectively). Eighty-six percent of the responding PICUs stated to use neuromuscular blocking agents in some scenarios. Monitoring of paralysed patients was preferably done by observation of vital signs with electronic devices support.
Conclusions
This survey provides an overview of current analgosedation practices among European PICUs. Drugs of choice, dosing and assessment strategies were shown to differ widely. Further research and development of evidence-based guidelines for optimal drug dosing and analgosedation assessment are needed.
Journal Article
Therapeutic Potential of Citrulline as an Arginine Supplement: A Clinical Pharmacology Review
Supplemental arginine has shown promise as a safe therapeutic option to improve endogenous nitric oxide (NO) regulation in cardiovascular diseases associated with endothelial dysfunction. In clinical studies in adults,
l
-arginine, an endogenous amino acid, was reported to improve cardiovascular function in hypertension, pulmonary hypertension, preeclampsia, angina, and MELAS (mitochondrial encephalomyopathy, lactic acidosis, and stroke-like episodes) syndrome.
l
-citrulline, a natural precursor of
l
-arginine, is more bioavailable than
l
-arginine because it avoids hepatic first-pass metabolism and has a longer circulation time. Although not yet well-studied, arginine/citrulline has immense therapeutic potential in some life-threatening diseases in children. However, the optimal clinical development of arginine or citrulline in children requires more information about pharmacokinetics and exposure–response relationships at appropriate ages and under relevant disease states. This article summarizes the preclinical and clinical studies of arginine/citrulline in both adults and children, including currently available pharmacokinetic information. The pharmacology of arginine/citrulline is confounded by several patient-specific factors such as variations in baseline arginine/citrulline due to developmental ages and disease states. Currently available pharmacokinetic studies are insufficient to inform the optimal design of clinical studies, especially in children. Successful bench-to-bedside clinical translation of arginine supplementation awaits information from well-designed pharmacokinetic/pharmacodynamic studies, along with pharmacometric approaches.
Journal Article
3D Printed “Starmix” Drug Loaded Dosage Forms for Paediatric Applications
PurposeThree- dimensional (3D) printing has received significant attention as a manufacturing process for pharmaceutical dosage forms. In this study, we used Fusion Deposition Modelling (FDM) in order to print “candy – like” formulations by imitating Starmix® sweets to prepare paediatric medicines with enhanced palatability.MethodsHot melt extrusion processing (HME) was coupled with FDM to prepare extruded filaments of indomethacin (IND), hypromellose acetate succinate (HPMCAS) and polyethylene glycol (PEG) formulations and subsequently feed them in the 3D printer. The shapes of the Starmix® objects were printed in the form of a heart, ring, bottle, ring, bear and lion. Differential scanning calorimetry (DSC), X-ray powder diffraction (XRPD), Fourier Transform Infra-red Spectroscopy (FT-IR) and confocal Raman analysis were used to assess the drug – excipient interactions and the content uniformity.ResultsPhysicochemical analysis showed the presence of molecularly dispersed IND in the printed tablets. In vivo taste masking evaluation demonstrated excellent masking of the drug bitterness. The printed forms were evaluated for drug dissolution and showed immediate IND release independently of the printed shape, within 60 min.Conclusions3D printing was used successfully to process drug loaded filaments for the development of paediatric printed tablets in the form of Starmix® designs.
Journal Article