全膝关节置换术后患者主导的疼痛自我管理（PaDSMaP）与常规治疗的比较：一项随机对照试验。
Patient-directed self-management of pain (PaDSMaP) compared to treatment as usual following total knee replacement; a randomised controlled trial.
作者信息
Deane Katherine H O, Gray Richard, Balls Paula, Darrah Clare, Swift Louise, Clark Alan B, Barton Garry R, Morris Sophie, Butters Sue, Bullough Angela, Flaherty Helen, Talbot Barbara, Sanders Mark, Donell Simon T
机构信息
School of Health Sciences, University of East Anglia, Norwich Research Park, Norwich, UK.
Present address: School of Nursing and Midwifery, Latrobe University, Melbourne, Australia.
出版信息
BMC Health Serv Res. 2018 May 10;18(1):346. doi: 10.1186/s12913-018-3146-2.
BACKGROUND
Self-administration of medicines by patients whilst in hospital is being increasingly promoted despite little evidence to show the risks and benefits. Pain control after total knee replacement (TKR) is known to be poor. The aim of the study was to determine if patients operated on with a TKR who self-medicate their oral analgesics in the immediate post-operative period have better pain control than those who receive their pain control by nurse-led drug rounds (Treatment as Usual (TAU)).
METHODS
A prospective, parallel design, open-label, randomised controlled trial comparing pain control in patient-directed self-management of pain (PaDSMaP) with nurse control of oral analgesia (TAU) after a TKR. Between July 2011 and March 2013, 144 self-medicating adults were recruited at a secondary care teaching hospital in the UK. TAU patients (n = 71) were given medications by a nurse after their TKR. PaDSMaP patients (n = 73) took oral medications for analgesia and co-morbidities after two 20 min training sessions reinforced with four booklets. Primary outcome was pain (100 mm visual analogue scale (VAS)) at 3 days following TKR surgery or at discharge (whichever came soonest). Seven patients did not undergo surgery for reasons unrelated to the study and were excluded from the intention-to-treat (ITT) analysis.
RESULTS
ITT analysis did not detect any significant differences between the two groups' pain scores. A per protocol (but underpowered) analysis of the 60% of patients able to self-medicate found reduced pain compared to the TAU group at day 3/discharge, (VAS -9.9 mm, 95% CI -18.7, - 1.1). One patient in the self-medicating group over-medicated but suffered no harm.
CONCLUSION
Self-medicating patients did not have better (lower) pain scores compared to the nurse-managed patients following TKR. This cohort of patients were elderly with multiple co-morbidities and may not be the ideal target group for self-medication.
TRIAL REGISTRATION
ISRCTN10868989 . Registered 22 March 2012, retrospectively registered.
背景
尽管几乎没有证据表明风险和益处，但住院患者自行用药的情况正日益增多。全膝关节置换术（TKR）后的疼痛控制已知较差。本研究的目的是确定在术后即刻自行服用口服镇痛药的TKR手术患者是否比通过护士主导的药物巡诊接受疼痛控制的患者（常规治疗（TAU））有更好的疼痛控制。
方法
一项前瞻性、平行设计、开放标签的随机对照试验，比较TKR术后患者自主管理疼痛（PaDSMaP）与护士控制口服镇痛（TAU）的疼痛控制情况。2011年7月至2013年3月期间，在英国一家二级护理教学医院招募了144名自行用药的成年人。TAU组患者（n = 71）在TKR术后由护士给药。PaDSMaP组患者（n = 73）在经过两次20分钟的培训课程并辅以四本小册子强化后，自行服用口服镇痛药及治疗合并症的药物。主要结局是TKR手术后3天或出院时（以先到者为准）的疼痛程度（100毫米视觉模拟量表（VAS））。7名患者因与研究无关的原因未接受手术，被排除在意向性分析（ITT）之外。
结果
ITT分析未发现两组疼痛评分有任何显著差异。对60%能够自行用药的患者进行的符合方案（但效能不足）分析发现，与TAU组相比，在第3天/出院时疼痛减轻（VAS -9.9毫米，95%可信区间 -18.7，-1.1）。自行用药组有1名患者用药过量但未造成伤害。
结论
与TKR术后由护士管理的患者相比，自行用药的患者疼痛评分并未更低。这组患者为老年人且有多种合并症，可能不是自行用药的理想目标群体。
试验注册
ISRCTN10868989。于2012年3月22日注册，追溯注册。
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