Prescription After CesareanTrial - (PACT) MFMU Supplement

剖腹产试验后的处方 - (PACT) MFMU 补充

基本信息

批准号：
10434255
负责人：
Rebecca Gersnoviez Clifton
金额：
$ 55万
依托单位：
GEORGE WASHINGTON UNIVERSITY
依托单位国家：
美国
项目类别：
财政年份：
2021
资助国家：
美国
起止时间：
2021-07-01 至 2022-03-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/10434255
关键词：
Absence of pain sensation Acetaminophen Acute Analgesics Birth Caring Cesarean section Cessation of life Chronic Client satisfaction Clinical Data Dependence Development Face Hospitalization Hospitals Ibuprofen Individual Ingestion Institution Lead Life Maternal Mortality Maternal-Fetal Medicine Units Network Morphine National Institute of Child Health and Human Development Non-Steroidal Anti-Inflammatory Agents Operative Surgical Procedures Opioid Opioid Analgesics Overdose Oxycodone Pain Pain Threshold Pain intensity Pain interference Pain management Patients Play Postoperative Pain Postoperative Period Pregnancy Rate Prescription opioid overdose Process Protocols documentation Provider Randomized Regimen Reporting Role Surgeon Tablets Testing United States Woman adverse maternal outcomes impression improved improved outcome infant outcome milligram non-opioid analgesic nonmedical use opioid epidemic opioid use pain score pandemic disease postcesarean section pregnancy associated death prescription opioid randomized trial satisfaction shared decision making standard of care

项目摘要

PROJECT SUMMARY Cesarean delivery is the most commonly performed major surgical procedure in the United States. Systemic opioids have been universally used for post-cesarean analgesia management, with the number of tablets prescribed varying significantly between providers and institutions. Pain thresholds and analgesic requirements vary between patients, and studies suggest that most women are given prescriptions for at least 10 more tablets at discharge than needed. The consequence of over-prescribing opioids for 1.2 million cesareans annually is 12.5 million unused tablets. These unused tablets often go unguarded, and undisposed, providing an important reservoir of opioids that may be misused, diverted or accidentally ingested, contributing to the opioid crisis. The one-size-fits-all approach to pain management is clearly suboptimal. Some women may not even need opioids: one small study reported that pain scores were higher among women who were prescribed opioids than those who were prescribed ibuprofen and acetaminophen. While recent studies have evaluated opioid prescribing practices, there are limited data on the effect of using an individualized opioid prescription protocol following a cesarean delivery. The Eunice Kennedy Shriver National Institute of Child Health and Human Development Maternal Fetal Medicine Units (MFMU) Network proposes a non-inferiority multi-center unblinded randomized trial of 5,500 women undergoing a cesarean delivery who are randomized before discharge to either an individualized opioid prescription protocol (IOPP) that includes shared decision-making or to a fixed opioid prescription of 20 tablets of oxycodone 5mg which approximates current standard of care at the participating institutions. The primary aim is to evaluate whether IOPP with shared decision-making is not inferior to a fixed opioid prescription of 20 tablets of oxycodone 5mg in pain management defined as the presence/absence of moderate to severe pain at 1 week after discharge. Secondary aims will evaluate whether IOPP with shared decision making 1) decreases an opioid refill prescription, 2) decreases the total amount of opioid tablets prescribed and the total morphine milligram equivalents used, 3) has equivalent pain intensity and interference, and satisfactions scores, and 4) reduces adverse maternal and infant outcomes.

项目概要剖腹产是美国最常进行的主要外科手术。系统性阿片类药物已普遍用于剖腹产后镇痛管理，片剂数量提供者和机构之间的规定差异很大。疼痛阈值和镇痛需求患者之间存在差异，研究表明大多数女性都会开出至少 10 种以上的处方出院时服用的药片超过需要量。为 120 万名剖腹产患者过量服用阿片类药物的后果每年有 1250 万片未使用的平板电脑。这些未使用的平板电脑通常无人看守和处置，提供阿片类药物的重要储存库，可能被滥用、转移或意外摄入，从而导致阿片类药物危机。一刀切的疼痛管理方法显然不是最理想的。有些女性可能不会甚至需要阿片类药物：一项小型研究报告称，服用阿片类药物的女性疼痛评分更高阿片类药物的使用率高于那些服用布洛芬和对乙酰氨基酚的患者。虽然最近的研究评估了阿片类药物处方实践，关于使用个体化阿片类药物处方的效果的数据有限剖腹产后的协议。尤尼斯·肯尼迪·施赖弗国家儿童健康和人类发展研究所母胎 Medicine Units (MFMU) Network 提出一项包含 5,500 名患者的非劣效性多中心非盲随机试验接受剖腹产的妇女在出院前随机接受个体化阿片类药物治疗处方方案 (IOPP)，包括共同决策或 20 片的固定阿片类药物处方羟考酮 5 毫克，接近参与机构当前的护理标准。初级目的是评估具有共同决策的 IOPP 是否不劣于 20 的固定阿片类药物处方羟考酮 5 毫克片剂在疼痛管理中的定义是存在/不存在中度至重度疼痛出院后1周。次要目标将评估 IOPP 是否具有共同决策能力 1) 减少阿片类药物补充处方，2) 减少阿片类药物片剂处方总量和总量使用吗啡毫克当量，3) 具有同等的疼痛强度和干扰以及满意度分数，4) 减少不良的母婴结局。