Stessel Björn, Theunissen Maurice, Fiddelers Audrey A, Joosten Elbert A, Kessels Alfons G, Gramke Hans-Fritz, Marcus Marco A
Department of Anesthesiology, Maastricht University Medical Center+, P. Debyelaan 25, 6229 HX Maastricht, the Netherlands ; Current affiliation: Department of Anesthesiology and Pain Treatment, Jessa Hospital, Stadsomvaart 11, 3500 Hasselt, Belgium.
Department of Anesthesiology, Maastricht University Medical Center+, P. Debyelaan 25, 6229 HX Maastricht, the Netherlands.
Curr Ther Res Clin Exp. 2014 Nov 28;76:120-5. doi: 10.1016/j.curtheres.2014.10.001. eCollection 2014 Dec.
Strong opioids in the home setting after ambulatory surgery have rarely been studied for fear of hazardous adverse effects such as respiratory depression.
We compared the efficacy of paracetamol/controlled-release (CR) oxycodone and paracetamol/naproxen for treatment of acute postoperative pain at home after ambulatory surgery. Secondary outcomes were adverse effects of study medication, treatment satisfaction, and postoperative analgesic compliance.
Patients undergoing ambulatory knee arthroscopy or inguinal hernia repair surgery (n = 105) were randomized into 3 groups: Group1 paracetamol/naproxen (n = 35), Group 2 paracetamol/CR oxycodone for 24 hours (n = 35), and Group 3 paracetamol/CR oxycodone for 48 hours (n = 35). Pain intensity at movement and at rest using a visual analog scale as well as satisfaction with postoperative analgesia and side effects were recorded for up to 48 hours postoperatively. Compliance with study medication was also assessed.
For pain at movement and at rest, no significant differences were found between the paracetamol/naproxen group and either the paracetamol/CR oxycodone for 24 hours group (β = 2.6 [4.9]; P = 0.597) or the paracetamol/CR oxycodone for 48 hours (β = -1.7 [5.1]; P = 0.736). No major adverse effects of study medication were registered and satisfaction with postoperative pain treatment was high in all groups. Compliance was comparable across the groups. Despite clear instructions, 8 patients with the lowest pain scores did not use any of the prescribed pain medication.
Paracetamol/CR oxycodone and paracetamol/naproxen are equally effective in treatment of acute postoperative pain at home after ambulatory surgery with comparable patient satisfaction level. We suggest paracetamol/CR oxycodone to be a valuable alternative for the current paracetamol/naproxen gold standard, particularly in patients with a contraindication for nonsteroidal anti-inflammatory drugs. ClinicalTrials.gov identifier: NCT02152592.
由于担心诸如呼吸抑制等有害不良反应，门诊手术后在家中使用强效阿片类药物的情况鲜有研究。
我们比较了对乙酰氨基酚/控释（CR）羟考酮和对乙酰氨基酚/萘普生治疗门诊手术后在家中的急性术后疼痛的疗效。次要结局是研究药物的不良反应、治疗满意度和术后镇痛依从性。
接受门诊膝关节镜检查或腹股沟疝修补手术的患者（n = 105）被随机分为3组：第1组对乙酰氨基酚/萘普生（n = 35），第2组对乙酰氨基酚/CR羟考酮用药24小时（n = 35），第3组对乙酰氨基酚/CR羟考酮用药48小时（n = 35）。术后长达48小时记录使用视觉模拟量表评估的活动时和静息时的疼痛强度，以及对术后镇痛和副作用的满意度。还评估了对研究药物的依从性。
对于活动时和静息时的疼痛，对乙酰氨基酚/萘普生组与对乙酰氨基酚/CR羟考酮用药24小时组（β = 2.6 [4.9]；P = 0.597）或对乙酰氨基酚/CR羟考酮用药48小时组（β = -1.7 [5.1]；P = 0.736）之间均未发现显著差异。未记录到研究药物的重大不良反应，所有组对术后疼痛治疗的满意度都很高。各组之间的依从性相当。尽管有明确指示，但8例疼痛评分最低的患者未使用任何处方的止痛药物。
对乙酰氨基酚/CR羟考酮和对乙酰氨基酚/萘普生在门诊手术后在家中治疗急性术后疼痛方面同样有效，患者满意度相当。我们建议对乙酰氨基酚/CR羟考酮是当前对乙酰氨基酚/萘普生金标准的有价值替代药物，特别是在有非甾体抗炎药禁忌证的患者中。ClinicalTrials.gov标识符：NCT02152592。
