Pediatric Drug Development in Anesthesiology: An FDA Perspective

Schultheis, Lex; Mathis, Lisa L.; Roca, Rigoberto; Simone, Arthur F.; Hertz, Sharon; Rappaport, Bob A.

doi:10.1213/01.ane.0000228302.15293.de

Cited by 16 publications

(7 citation statements)

References 10 publications

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“…Although the FDA is authorized to regulate off‐label marketing, it does not regulate the practice of medicine nor did the off‐label use of FDA approve medications in clinical practice . Since 1997, several laws (i.e., Food and Drug Administration Modernization Act, Best Pharmaceutical for Children Act, and Pediatric Research Equity Act) have been enacted to increase the amount of information regarding the level of safety and efficacy of medications and to control off‐label prescribing in pediatric populations . Although such laws exist and the labeling of many drugs now includes more usable pediatric prescribing information as a result, we find that off‐label prescribing for antidepressants was quite prevalent even with these FDA pediatric acts in effect.…”

Section: Discussionsupporting

confidence: 75%

Off‐label prescribing patterns of antidepressants in children and adolescents

Lee

Teschemaker

Johann-Liang

et al. 2011

Pharmacoepidemiology and Drug

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Section: Discussionsupporting

confidence: 75%

Off‐label prescribing patterns of antidepressants in children and adolescents

Lee

Teschemaker

Johann-Liang

et al. 2011

Pharmacoepidemiology and Drug

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“…Nevertheless, because of differences in the clinical pharmacology of muscle relaxants between adult and pediatric patients, 18 it is necessary to conduct clinical trials in the pediatric population. 31,32 Neonates were not included in this study because there are insufficient data on the use of rocuronium in this age group. As in other age groups, the median time to recovery of the TOF ratio to 0.9 in the infant group decreased markedly with increasing doses of sugammadex.…”

Section: Discussionmentioning

confidence: 99%

Reversal of Rocuronium-induced Neuromuscular Blockade with Sugammadex in Pediatric and Adult Surgical Patients

Plaud

Meretoja

Hofmockel³

et al. 2009

Anesthesiology

178

123

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“…Off-label use of drugs for sedation of children has grown exponentially prior to the development of well-controlled clinical trials in the pediatric population. A number of legislative changes are intended to improve drug labeling for safe and efficacious sedation in children [84,85].…”

Section: Special Consideration For Pediatric Drug Use and Developmentmentioning

confidence: 99%

Drug selection for sedation and general anesthesia in children undergoing ambulatory magnetic resonance imaging

Jung

2020

Yeungnam Univ J Med

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The prevalence of magnetic resonance imaging (MRI) for diagnosing and monitoring a wide range of disease in children continues to expand with the efficacy benefit of providing high-resolution images of tissue anatomy and quantitative function and the safety advantage of a lack of ionizing radiation [1,2]. Aspects of MRI scans such as loud noises, confined bore of the magnet, and the required immobility to prevent motion artifacts are the causes of anxiety and barriers to successful performance of the procedure in children younger than 6 years and those at any age with development delay, claustrophobia, or involuntary movements or con-The demand for drug-induced sedation for magnetic resonance imaging (MRI) scans have substantially increased in response to increases in MRI utilization and growing interest in anxiety in children. Understanding the pharmacologic options for deep sedation and general anesthesia in an MRI environment is essential to achieve immobility for the successful completion of the procedure and ensure rapid and safe discharge of children undergoing ambulatory MRI. For painless diagnostic MRI, a single sedative/anesthetic agent without analgesia is safer than a combination of multiple sedatives. The traditional drugs, such as chloral hydrate, pentobarbital, midazolam, and ketamine, are still used due to the ease of administration despite low sedation success rate, prolonged recovery, and significant adverse events. Currently, dexmedetomidine, with respiratory drive preservation, and propofol, with high effectiveness and rapid recovery, are preferred for children undergoing ambulatory MRI. General anesthesia using propofol or sevoflurane can also provide predictable rapid time to readiness and scan times in infants or children with comorbidities. The selection of appropriate drugs as well as sufficient monitoring equipment are vital for effective and safe sedation and anesthesia for ambulatory pediatric MRI.

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Pediatric Drug Development in Anesthesiology: An FDA Perspective

Cited by 16 publications

References 10 publications

Off‐label prescribing patterns of antidepressants in children and adolescents

Off‐label prescribing patterns of antidepressants in children and adolescents

Reversal of Rocuronium-induced Neuromuscular Blockade with Sugammadex in Pediatric and Adult Surgical Patients

Drug selection for sedation and general anesthesia in children undergoing ambulatory magnetic resonance imaging

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