Safety Assessment of Perioperative Pain Medications for Children (SAPPhire)

儿童围手术期止痛药的安全性评估 (SAPPhire)

• 批准号: 10472724
• 负责人: Mehul V. Raval
• 金额: $ 20万
• 依托单位: NORTHWESTERN UNIVERSITY AT CHICAGO
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-08-20 至 2024-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10472724
• 关键词: Acetaminophen; Address; Adherence; Admission activity; Adolescent; Adoption; Adult; Affect; American College of Surgeons; Analgesics; Anesthetics; Brain; Caregivers; Catalogs; Child; Childhood; Clinical; Codeine; Collection; Critical Care; Data; Data Collection; Data Sources; Development; Drug Prescriptions; Drug usage; Electronic Health Record; Ensure; Equilibrium; Exposure to; Feedback; Fright; Future; Guidelines; Health; Healthcare; Home; Hospitalization; Hospitals; Illinois; Impairment; Information Systems; Intervention; Knowledge; Lead; Length of Stay; Local Anesthetics; Measurement; Measures; Minor; Nerve Block; Non-Steroidal Anti-Inflammatory Agents; Observational Study; Operative Surgical Procedures; Opioid; Outcome; Outpatients; Pain; Pain Measurement; Pain management; Pathway interactions; Patient Outcomes Assessments; Patients; Pediatric Hospitals; Pediatric Surgical Procedures; Perioperative; Physicians; Population; Population Heterogeneity; Postoperative Pain; Postoperative Period; Practice Management; Procedures; Recommendation; Recording of previous events; Registries; Reporting; Research; Risk Factors; Rural; Safety; Services; Subgroup; Surgeon; Surgical Wound Infection; Surveys; Training; United States; United States Food and Drug Administration; Variant; comorbidity; demographics; early adolescence; early childhood; evidence based guidelines; health data; hospital readmission; improved; individual patient; innovation; inpatient surgery; non-opioid analgesic; nonmedical use; opioid epidemic; opioid exposure; opioid misuse; opioid overdose; opioid use; patient subsets; patients who use opioids; pediatric patients; pill; prescription opioid; prescription opioid misuse; programs; safety assessment; surgery outcome

PROJECT ABSTRACT Per capita opioid prescribing is higher in the US than in any other nation and the opioid crisis affects not only adults, but, also children and adolescents. Despite increases in pediatric hospitalizations related to opioid poisonings and opioid-related critical care unit admissions, yet, opioid use in children is understudied and underestimated. This gap in research is alarming given that drug use impairs child brain development and use of prescription opioids during childhood/early adolescence is a risk factor for prescription opioid misuse. One path to childhood opioid misuse begins with exposure after surgery for pain control and more than 2 million children undergo surgery in the US each year. Evidence also suggests that pediatric surgeons often prescribe more opioids than necessary following minor procedures with more than 50% of prescribed pills remaining unused, and resulting in excess opioids being stored in homes with children and, thus, becoming accessible for nonmedical use. Currently, no comprehensive data source exists that catalogues pediatric surgery perioperative pain management practices, including pain medication prescribing and that also assesses pain control, both of which are necessary to develop evidence-based recommendations for pediatric surgery perioperative pain management. This project, Safety Assessment of Perioperative Pain Medications for Children (SAPPhire),will create this unique data source to study, understand, and improve current pediatric surgery perioperative pain management, by combining data about current pain management practices (e.g., local anesthetics, regional nerve blocks, non-opioid analgesics, and pediatric-specific opioid prescribing practices), with patient-level demographic, health (e.g., comorbid conditions, surgical procedure), and outcomes (e.g., length of stay, surgical-site infections, and readmission) data from the American College of Surgeons (ACS) National Surgical Quality Improvement Program-Pediatric (NSQIP-P). In addition, post-discharge opioid use and patient reported outcomes (PROs) on pain control and limitations of daily activities will be collected. Combined, these data will guide feedback and interventions to address surgeon- and hospital-level pain management practice variation and identify high “opioid-use” procedures and high “opioid-exposed” subgroups of pediatric surgical patients. The study will also assess adherence to FDA opioid medication contraindications and warnings. This formative study will provide essential information needed to develop pediatric procedure- and patient-specific guidelines for pain management. Lessons learned from SAPPhire will facilitate wider adoption of perioperative pain management practices across to the >150 NSQIP-P hospitals across the United States.

项目摘要 美国的人均阿片类药物处方量高于任何其他国家，并且阿片类药物危机影响不 尽管与阿片类药物相关的儿科住院人数有所增加，但仅限于成人。 中毒和阿片类药物相关的重症监护病房入院，然而，儿童阿片类药物的使用尚未得到充分研究和 鉴于吸毒会损害儿童大脑的发育和使用，这一研究差距令人震惊。 儿童/青春期早期使用处方阿片类药物是处方阿片类药物滥用的一个危险因素。 儿童滥用阿片类药物的途径始于控制疼痛手术后的暴露，超过 200 万人 有证据表明，美国每年都有儿童接受手术。 小手术后服用的阿片类药物超过必要量，且处方药物剩余量超过 50% 未使用，并导致过量的阿片类药物储存在有儿童的家庭中，从而可供儿童使用 非医疗用途。 目前，不存在对小儿手术围手术期疼痛进行分类的综合数据源 管理实践，包括止痛药处方以及评估疼痛控制，两者 对于小儿手术围手术期疼痛制定循证建议是必要的 该项目，即儿童围手术期止痛药的安全性评估（SAPPhire），将 创建这个独特的数据源来研究、理解和改善当前的小儿手术围手术期疼痛 通过结合当前疼痛管理实践的数据（例如局部麻醉剂、区域麻醉剂）来进行管理 神经阻滞、非阿片类镇痛药和儿科特定阿片类药物处方实践），以及患者层面 人口统计、健康状况（例如合并症、手术程序）和结果（例如住院时间、 手术部位感染和再入院）数据来自美国外科医生学会 (ACS) National Surgical 儿科质量改进计划 (NSQIP-P) 此外，出院后阿片类药物的使用和患者报告。 将收集有关疼痛控制和日常活动限制的结果（PRO）。 指导反馈和干预措施，以解决外科医生和医院层面的疼痛管理实践差异 并确定高“阿片类药物使用”程序和高“阿片类药物暴露”儿科手术患者亚组。 该研究还将评估对 FDA 阿片类药物禁忌症和警告的遵守情况。 研究将提供制定儿科手术和患者特定指南所需的基本信息 SAPPhire 的疼痛管理经验将促进围手术期疼痛的更广泛采用。 管理实践遍及美国超过 150 家 NSQIP-P 医院。