Ng T-T, Diamantaras D, Priestley J, Redman J, De Silva N, Mahanta V
ENT Unit,Department of Surgery,Frankston Hospital,Peninsula Health,Frankston,Australia.
J Laryngol Otol. 2017 Jan;131(S1):S18-S28. doi: 10.1017/S0022215116009476.
To evaluate the efficacy and safety of celecoxib for pain management in post-tonsillectomy adult patients.
A randomised, double-blind, placebo-controlled, phase 3 clinical trial was conducted in an adult population (aged 18-55 years), with a parallel group design using an allocation ratio of 1:1.
Eighty patients underwent elective tonsillectomy or adenotonsillectomy, operated on by one surgeon. They were discharged home with randomly assigned celecoxib or placebo, together with regular post-tonsillectomy medications (paracetamol and Endone). Pain scores were measured from post-operative days 1 to 10. All patients were assessed on post-operative days 5, 12 and 28.
There were no statistically significant differences in the daily or overall pain scores, the total intake of Endone, or the time taken to achieve freedom from pain after tonsillectomy between the study arms (n = 40 each arm). The celecoxib-treated group experienced significantly more vomiting (celecoxib vs placebo p < 0.001 (Mann-Whitney test), confidence interval = 0.57 to 0.76).
Celecoxib usage was associated with significantly more vomiting and did not reduce narcotic analgesia requirement post-tonsillectomy.
评估塞来昔布用于扁桃体切除术后成年患者疼痛管理的疗效和安全性。
在成年人群（年龄18 - 55岁）中进行了一项随机、双盲、安慰剂对照的3期临床试验，采用1:1的分配比例进行平行组设计。
80例患者接受了择期扁桃体切除术或腺样体扁桃体切除术，由一名外科医生进行手术。他们出院时被随机分配服用塞来昔布或安慰剂，同时服用常规的扁桃体切除术后药物（对乙酰氨基酚和恩多）。从术后第1天到第10天测量疼痛评分。所有患者在术后第5天、第12天和第28天进行评估。
各研究组（每组n = 40）在每日或总体疼痛评分、恩多的总摄入量或扁桃体切除术后达到无痛所需时间方面无统计学显著差异。塞来昔布治疗组呕吐明显更多（塞来昔布与安慰剂相比，p < 0.001（曼 - 惠特尼检验），置信区间 = 0.57至0.76）。
使用塞来昔布与明显更多的呕吐相关，且未降低扁桃体切除术后的麻醉镇痛需求。
