Lawrence Amy E, Carsel Alex J, Leonhart Karen L, Richards Holden W, Harbaugh Calista M, Waljee Jennifer F, McLeod Daryl J, Walz Patrick C, Minneci Peter C, Deans Katherine J, Cooper Jennifer N
Center for Surgical Outcomes Research, The Research Institute at Nationwide Children's Hospital, Columbus, Ohio.
Department of Pediatric Surgery, Nationwide Children's Hospital, Columbus, Ohio.
JAMA Pediatr. 2019 Aug 1;173(8):e191695. doi: 10.1001/jamapediatrics.2019.1695. Epub 2019 Aug 5.
Although opioids are an important component of pain management for children recovering from surgery, postoperative opioid prescribing has contributed to the current opioid crisis in the United States because these medications are often prescribed in excess and are rarely properly disposed. One potential strategy to combat opioid misuse is to remove excess postoperative opioids from circulation by providing patients with drug disposal products that enable safe disposal of opioids in the home garbage.
To determine whether the provision of a drug disposal bag increases proper opioid disposal among the families of pediatric patients undergoing ambulatory surgery.
DESIGN, SETTING, AND PARTICIPANTS: This randomized clinical trial enrolled 202 parents or guardians of children 1 to 17 years of age who underwent otolaryngologic or urologic surgery at the outpatient surgery centers of a tertiary children's hospital in Columbus, Ohio, from June to December 2018 and who received an opioid prescription prior to discharge.
Families randomized to intervention were provided a drug disposal bag containing activated charcoal and instructions for use plus standard postoperative discharge instructions on opioid use, storage, and disposal. Families in standard care arm received standard postoperative discharge instructions only. All participants completed a baseline survey and a follow-up survey 2 to 4 weeks postoperatively.
Primary outcome was proper opioid disposal, defined as disposal using a drug disposal bag or a disposal method recommended by the US Food and Drug Administration.
Of 202 parents or guardians enrolled, 181 completed follow-up (92 in intervention arm and 89 in standard care arm). Most patients in both groups were white (75 [73.5%] vs 79 [80.6%]) and male (63 [61.2%] vs 54 [54.6%]), and the median (interquartile range) age was 6 (5-9) years in the intervention arm and 7 (6-10) years in the standard care arm. For intention-to-treat analyses, 92 families receiving a disposal bag and 89 families not receiving a disposal bag were included. Among them, 66 families (71.7%) randomized to receive a disposal bag reported properly disposing of their child's opioids, whereas 50 parents (56.2%) who did not receive a disposal bag reported proper opioid disposal (difference in proportions, 15.5%; 95% CI, 1.7%-29.3%; P = .03). Among only those families who filled an opioid prescription and had leftover opioids after resolution of their child's pain, 66 of 77 parents or guardians (85.7%) who had received a disposal bag and 50 of 77 parents or guardians (64.9%) who had received standard care reported properly disposing of their child's opioids (difference in proportions, 20.8%; 95% CI, 7.6%-34.0%).
Results of this study indicated that providing drug disposal bags to families of children receiving postoperative opioids increased the likelihood of excess opioid disposal. Greater availability of disposal products may complement ongoing prescribing reduction efforts aimed at decreasing opioid misuse.
ClinicalTrials.gov identifier: NCT03575377.
尽管阿片类药物是术后恢复的儿童疼痛管理的重要组成部分，但术后阿片类药物的处方导致了美国目前的阿片类药物危机，因为这些药物经常被过量处方，而且很少得到妥善处置。对抗阿片类药物滥用的一种潜在策略是通过为患者提供药物处置产品，使阿片类药物能够在家用垃圾中安全处置，从而减少术后过量阿片类药物的流通。
确定提供一个药物处置袋是否能增加接受门诊手术的儿科患者家庭对阿片类药物的正确处置。
设计、地点和参与者：这项随机临床试验招募了202名1至17岁儿童的父母或监护人，这些儿童于2018年6月至12月在俄亥俄州哥伦布市一家三级儿童医院的门诊手术中心接受了耳鼻喉科或泌尿外科手术，且在出院前接受了阿片类药物处方。
随机分配到干预组的家庭会收到一个装有活性炭的药物处置袋以及使用说明，外加关于阿片类药物使用、储存和处置的标准术后出院指导。标准护理组的家庭仅收到标准术后出院指导。所有参与者均完成了基线调查以及术后2至4周的随访调查。
主要结局是阿片类药物的正确处置，定义为使用药物处置袋或美国食品药品监督管理局推荐的处置方法进行处置。
在登记的202名父母或监护人中，181人完成了随访（干预组92人，标准护理组89人）。两组中的大多数患者为白人（75 [73.5%] 对79 [80.6%]）且为男性（63 [61.2%] 对54 [54.6%]），干预组的年龄中位数（四分位间距）为6（5 - 9）岁，标准护理组为7（6 - 10）岁。对于意向性分析，纳入了92个收到处置袋的家庭和89个未收到处置袋的家庭。其中，随机分配接受处置袋的66个家庭（71.7%）报告正确处置了孩子的阿片类药物，而未收到处置袋的50位家长（56.2%）报告正确处置了阿片类药物（比例差异为15.5%；95%置信区间，1.7% - 29.3%；P = 0.03）。仅在那些开具了阿片类药物处方且孩子疼痛缓解后有剩余阿片类药物的家庭中，收到处置袋的77位父母或监护人中有66位（85.7%）报告正确处置了孩子的阿片类药物，收到标准护理的77位父母或监护人中有50位（64.9%）报告正确处置了孩子的阿片类药物（比例差异为20.8%；95%置信区间，7.6% - 34.0%）。
本研究结果表明，为接受术后阿片类药物治疗的儿童家庭提供药物处置袋可增加过量阿片类药物被处置的可能性。更多的处置产品供应可能会补充正在进行的旨在减少阿片类药物滥用的处方减少努力。
ClinicalTrials.gov标识符：NCT03575377。
