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一项双盲随机对照试验,评估阿片类药物处置说明结合家长教育对小儿门诊泌尿外科手术后正确阿片类药物处置率的疗效。

A Double-blinded Randomized Controlled Trial Assessing the Efficacy of Opioid Disposal Instructions with Parental Education on Proper Opioid Disposal Rates Following Ambulatory Pediatric Urologic Surgery.

作者信息

Galansky Logan, Shah Manuj, Sholklapper Tamir, Crigger Chad, Patel Hiten D, Harris Kelly, Wang Ming-Hsien, Wu Charlotte, Gearhart John P, Gabrielson Andrew T, Di Carlo Heather N

机构信息

James Buchanan Brady Urological Institute, Johns Hopkins University School of Medicine, Baltimore, MD.

Department of Urology, Albert Einstein Medical Center, Philadelphia, PA.

出版信息

Urology. 2024 Dec;194:203-210. doi: 10.1016/j.urology.2024.08.017. Epub 2024 Aug 22.

DOI:10.1016/j.urology.2024.08.017
PMID:39173931
Abstract

OBJECTIVES

To determine if the administration of standardized opioid disposal instructions with focused parental education improves proper disposal of leftover opioid medication among families of children undergoing ambulatory urologic surgery compared to routine postoperative instructions.

METHODS

A prospective, double-blinded, single-center randomized controlled trial was conducted in children 6-18 years undergoing ambulatory urology procedures between October 2021 and April 2023. Patients were randomized (1:1) to receive either the Food and Drug Administration (FDA) opioid disposal best practices worksheet plus nursing parental education or routine postoperative instructions alone. All patients were prescribed acetaminophen and ibuprofen and a per-protocol rescue opioid prescription. The primary outcome was rate of proper opioid disposal at 10-14 days post-procedure. Secondary outcomes included parents' postoperative pain measure (PPPM) scores, numerical pain scale (NPS) scores, and weight-based opioid utilization at 48 hours and 10-14 days.

RESULTS

We randomized 104 participants (53 intervention, 51 control) with 97% (101/104) complete follow-up data at 10-14 days. Patient demographics, procedural characteristics, and analgesia use were similar between groups. We observed no significant difference in proper opioid disposal rates between arms (31% intervention vs 18% control; estimated difference in proportion 13% [95% CI, -4%-29%]; P = .1). There were no increased odds of proper disposal of leftover opioid medication at 10-14 days with the intervention compared to the control (OR 2.0 [95% CI 0.8-5.1]; P = .1). We observed no differences in PPPM scores, NPS scores, or opioid utilization at 48 hours or 10-14 days.

CONCLUSION

Providing formal opioid disposal instructions with parental education did not improve proper disposal of leftover opioid medication nor did it alter post-discharge opioid utilization after pediatric urologic surgery.

摘要

目的

与常规术后指导相比,确定给予标准化阿片类药物处置说明并进行针对性家长教育是否能改善门诊泌尿外科手术患儿家庭中剩余阿片类药物的妥善处置情况。

方法

2021年10月至2023年4月期间,对6至18岁接受门诊泌尿外科手术的儿童进行了一项前瞻性、双盲、单中心随机对照试验。患者被随机分组(1:1),分别接受美国食品药品监督管理局(FDA)阿片类药物处置最佳实践工作表加护理人员对家长的教育,或仅接受常规术后指导。所有患者均被开具对乙酰氨基酚和布洛芬以及按方案使用的急救阿片类药物处方。主要结局是术后10至14天妥善处置阿片类药物的比例。次要结局包括家长术后疼痛测量(PPPM)评分、数字疼痛量表(NPS)评分以及术后48小时和10至14天基于体重的阿片类药物使用量。

结果

我们随机分配了104名参与者(53名干预组,51名对照组),其中97%(101/104)在10至14天有完整的随访数据。两组患者的人口统计学特征、手术特征和镇痛药物使用情况相似。我们观察到两组之间妥善处置阿片类药物的比例无显著差异(干预组为31%,对照组为18%;比例估计差异为13% [95% CI,-4% - 29%];P = 0.1)。与对照组相比,干预组在术后10至14天妥善处置剩余阿片类药物的几率没有增加(OR 2.0 [95% CI 0.8 - 5.1];P = 0.1)。我们在PPPM评分、NPS评分或术后48小时和10至14天的阿片类药物使用量方面未观察到差异。

结论

提供正式的阿片类药物处置说明并进行家长教育,既未改善剩余阿片类药物的妥善处置情况,也未改变小儿泌尿外科手术后出院后阿片类药物的使用情况。

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