PCCM Network: Remedies for Opioid Tolerance & Withdrawal

PCCM 网络：阿片类药物耐受性的补救措施

• 批准号: 7355595
• 负责人: KANWALJEET S ANAND
• 金额: $ 45.4万
• 依托单位: ARKANSAS CHILDREN'S HOSPITAL RES INST
• 依托单位国家: 美国
• 财政年份: 2005
• 资助国家: 美国
• 起止时间: 2005-05-01 至 2009-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7355595
• 关键词: Absence of pain sensation; Abstinence; Admission activity; Agitation; Air; Analgesics; Anxiety; Area; Arkansas; Beds; Blinded; Care given by nurses; Characteristics; Child; Childhood; Clinical; Clinical Research; Clinical Trials; Combined Modality Therapy; Critical Care; Critical Illness; Critically ill children; Daily; Development; Devices; Discipline of Nursing; Dose; Effectiveness; Environment; Fentanyl; Future; Genetic Polymorphism; Goals; Grant; Hormones; Hydrocortisone; Immune; Incidence; Individual; Infant; Infusion procedures; Intensive Care; Invasive; Investigation; Lead; Leadership; Length; Lorazepam; Measures; Mechanical ventilation; Medical; Metabolic; Monitor; Multicenter Studies; Multicenter Trials; Naloxone; Narcotic Antagonists; Narcotics; Neurosecretory Systems; Numbers; Operative Surgical Procedures; Opioid; Opioid Analgesics; Opioid Receptor; Outcome; Pain; Patient Recruitments; Patients; Pediatric Hospitals; Pediatric Intensive Care Units; Personal Satisfaction; Pharmaceutical Preparations; Pharmacogenomics; Pharmacotherapy; Physiological; Placebos; Plasma; Predisposition; Prevention; Procedures; Randomized; Randomized Controlled Trials; Regulation; Relative (related person); Research; Research Personnel; Risk; Role; Safety; Scientific Evaluation; Sedation procedure; Services; Severities; Testing; Therapeutic; Time; Training; Training Programs; Translational Research; Trauma; Variant; Ventilator; Weaning; Withdrawal; base; biological adaptation to stress; experience; follow-up; hemodynamics; hypothalamic-pituitary-adrenal axis; indexing; member; neurobehavioral; new technology; novel; novel strategies; prevent; programs; response; sedative; skills; therapy design

DESCRIPTION (provided by applicant): A scientific evaluation of therapies used in the Pediatric ICU (PICU) is essential to build an evidence base that will guide the management of critically ill children. The 26-bed PICU at Arkansas Children's Hospital provides advanced trauma and intensive care to >1500 critically ill infants/children each year in a research driven, academic environment, supported by 8 Pediatric Intensivists, air/ground transport service, and all medical and surgical subspecialties. The P.I. is well-known for his clinical research on alleviating the pain and stress responses of infants and children by opioids or other agents, with participation and leadership of several multicenter clinical trials. The Study Coordinator has a rich background in academic nursing, grants management, coordination of multicenter studies and clinical experience in the PICU. This environment is well-suited for collaborative research with a strong track record of participation in multicenter trials, patient recruitment from a geographically defined area, and established follow-up programs. A randomized controlled trial to evaluate novel therapies for reducing opioid tolerance in ventilated critically ill children is proposed. Aim 1 will investigate the effects of low-dose Naloxone infusions on development of opioid tolerance and opioid withdrawal in PICU patients. Aim 2 will examine the impact of low-dose Naloxone infusions on clinical outcomes such as the need for additional analgesia/sedation , the duration of opioid weaning required and length of PICU stay after extubation. Aim 3 v/ill identify the clinical, pharmacogenomic, neuroendocrine, and neurobehavioral factors associated wii:h susceptibility to opioid tolerance and withdrawal in children. This study further proposes a public-private partnership to evaluate new technology for monitoring sedation in PICU patients. Opioid therapy is perhaps the most common drug therapy leading to PICU complications and warrants an investigation of novel approaches for prevention and treatment. The P.I., Study Coordinator, and Co-Investigators have protected research time, clinical and translational research experience, and the scientific skills to contribute to the proposed Collaborative PCCM Network, together with established educational and training programs for training future investigators.

描述（由申请人提供）：对儿科重症监护室（PICU）使用的治疗方法进行科学评估对于建立指导重症儿童管理的证据基础至关重要。阿肯色儿童医院（Arkansas Children Hospital）拥有26张床位的重症监护病房（PICU），在以研究为导向的学术环境中，由8名儿科重症医师、空中/地面运输服务以及所有医疗和外科专科提供支持，每年为1500名危重婴儿/儿童提供高级创伤和重症监护。P.I.以通过阿片类药物或其他药物减轻婴儿和儿童的疼痛和压力反应的临床研究而闻名，并参与和领导了几项多中心临床试验。研究协调员在学术护理、经费管理、多中心研究协调和PICU临床经验方面具有丰富的背景。这种环境非常适合合作研究，具有参与多中心试验的良好记录，从地理上确定的区域招募患者，并建立随访计划。提出了一项随机对照试验来评估减少阿片类药物耐受性的新疗法。目的1：探讨低剂量纳洛酮对PICU患者阿片类药物耐受性和戒断的影响。目的2将检查低剂量纳洛酮输注对临床结果的影响，如需要额外的镇痛/镇静，阿片类药物脱机所需的持续时间和拔管后PICU的停留时间。目的：研究儿童阿片类药物耐受性和戒断的临床、药物基因组学、神经内分泌和神经行为相关因素。本研究进一步提出了一种公私合作的方式来评估PICU患者镇静监测的新技术。阿片类药物治疗可能是最常见的导致PICU并发症的药物治疗，值得研究新的预防和治疗方法。pi、研究协调员和联合研究者拥有保护的研究时间、临床和转化研究经验和科学技能，为拟议的合作PCCM网络做出贡献，同时建立教育和培训计划，培训未来的研究者。