University of Utah Pediatric Pharmacology Research Unit

描述（由申请人提供）： 这是一份申请，旨在成为NICHD儿科药理学研究单位网络的成员，以增加儿科受试者的药物研究，增加对药物代谢发育变化的理解，并增加儿科人群的药物标签。作为本申请的一部分，我们建议研究吗啡的药代动力学及其代谢成葡萄糖醛酸苷在72小时输注。吗啡的疗效将通过有效的疼痛量表和婴儿EEG的双频谱分析来确定。另一项研究提出了一项随机、盲法比较在机械通气期间使用芬太尼和吗啡进行镇静和镇痛的新生儿治疗期间耐受性和戒断的发展。将根据暴露的药理学指标确定耐受性预测因子。将在开放标签治疗中确定可乐定治疗新生儿戒断综合征的有效性。第三项研究将确定S-Caine局部麻醉贴片中所含局部麻醉剂的全身暴露量。

DESCRIPTION (provided by applicant): This is an application to become a member of the NICHD Pediatric Pharmacology Research Unit Network to increase the study of medications in pediatric subjects, increase understanding of developmental changes in drug metabolism, and increase labeling of drugs for the pediatric population. As part of this application, we propose to study the pharmacokinetics of morphine and its metabolism into glucuronides during a 72 hr infusion. The efficacy of morphine will be determined with validated pain scales and bispectral analysis of infant EEG. Another study proposes a randomized, blinded comparison of the development of tolerance and abstinence during treatment of neonates with fentanyl and morphine for sedation and analgesia during mechanical ventilation. Predictors of tolerance will be determined based on pharmacologic measures of exposure. The effectiveness of clonidine for treatment of abstinence syndrome in neonates will be determined in an open-label treatment. A third study will determine the systemic exposure to local anesthetics contained in the S-Caine topical local anesthetic patch.