Best practice & research. Clinical anaesthesiology
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Best Pract Res Clin Anaesthesiol · Sep 2010
ReviewUse of pharmaceuticals 'off-label' in the neonate.
Neonates are frequently not studied in the development of a novel pharmacological agent. With lack of data to support safe and effective use of a new agent in this population, sponsors will not receive approval for labelling the agent for use in this age group from the United States Food and Drug Administration (USFDA). This causes a significant conundrum for the clinician. ⋯ This article provides the clinician with an introductory understanding of the approval process of pharmaceuticals in the United States by USFDA. Models of clinical trial design are noted. Examples of anaesthetic and non-anaesthetic agents and their development and use are discussed as either 'labelled' or 'off-label' indications.
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Best Pract Res Clin Anaesthesiol · Sep 2010
ReviewRegional anaesthesia and analgesia in the neonate.
A large number of published studies have shown that the use of diverse regional anaesthetic techniques is associated with high-quality pain relief following the different types of surgery and painful procedures that are commonly performed in neonatal patients. Apart from pain, few studies have examined other outcomes in this setting. Some data suggest a benefit with regional anaesthesia. ⋯ In conclusion, a large variety of local and regional anaesthetic techniques can be safely used in neonatal patients. The use of such techniques must obviously be associated with sufficient knowledge about the various techniques, as well as adherence to adequate dosage guidelines and other safety precautions. However, if these prerequisites are met, regional anaesthesia may offer great advantages to our smallest and most vulnerable patients.
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Premature infants have immature respiratory control that predisposes them to apnoea, haemoglobin oxygen desaturation and bradycardia. Apnoeas are loosely classified, according to the presence or absence of respiratory effort, into central, obstructive or mixed. There are a variety of conditions, in the perioperative period, that predispose an infant to apnoea, including: central nervous system (CNS) lesions, infections and sepsis, ambient temperature fluctuations, cardiac abnormalities, metabolic derangements, anaemia, upper airway structural abnormalities, necrotising enterocolitis, drug administration (including opiates and general anaesthetics) and possibly gastro-oesophageal reflux. ⋯ There is some evidence of both short- and long-term complications of repeated apnoeas in the neonatal period, but the causal relationship is difficult to establish. Continuous positive airway pressure and caffeine therapy (up to 10 mg kg(-1)) are the most common treatments of neonatal apnoea. The less soluble volatile agents and regional anaesthetic techniques (without concurrent sedation) are associated with a lower incident of postoperative apnoea.
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Neonatal care is advancing to levels where more neonates are now offered more invasive interventions, exposing them to more prolonged hospital care. Consequently, the provision of effective and consistent management of pain in these neonates has become a pressing challenge. Advances in neonatal care have not only increased the number of neonates, who are exposed to noxious stimuli, but, over recent decades, also altered the patterns of exposure. ⋯ Recent advances in the management of neonatal pain have been facilitated by improved methods of pain assessment and an increased understanding of the developmental aspects of nociception. Over the past decade, there have been some advances in the available pharmacological armamentarium, modest clarification of the risks of both untreated pain and aggressive analgesic practice and a greater recognition of non-pharmacological analgesic techniques. However, even advanced health systems fail to consistently articulate pain management policy for neonates, institute regular pain assessments and bridge the gaps between research and clinical practice.
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Best Pract Res Clin Anaesthesiol · Sep 2010
ReviewEvidence for the need for anaesthesia in the neonate.
Neonates are both capable of experiencing pain and memory formation, albeit implicit memory. During surgical procedures, insufficient ablation of the stress response and possible implicit memory formation of intra-operative events might result in adverse early and long-term outcomes. ⋯ It is thus the responsibility of the anaesthetist to provide sufficient anaesthesia for neonates undergoing surgery. A critical approach in weighing the risks and benefits of exposing a neonate to anaesthesia is prudent, and truly elective surgery should be delayed.