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塞来昔布与安慰剂用于扁桃体切除术的比较:一项前瞻性、随机、双盲、安慰剂对照试验

Celecoxib Versus Placebo in Tonsillectomy: A Prospective, Randomized, Double-Blind Placebo-Controlled Trial.

作者信息

Van Daele Douglas J, Bodeker Kellie L, Trask Douglas K

机构信息

University of Iowa, Iowa City, Iowa, USA

University of Iowa, Iowa City, Iowa, USA.

出版信息

Ann Otol Rhinol Laryngol. 2016 Oct;125(10):785-800. doi: 10.1177/0003489416654707. Epub 2016 Jun 29.

Abstract

OBJECTIVES

Celecoxib is a cyclooxygenase-2-specific inhibitor indicated to treat acute pain and pain secondary to osteoarthritis and rheumatoid arthritis. Surgical models of acute pain have demonstrated superior pain relief to placebo. The objective of this study was to test the safety and efficacy of celecoxib for pain relief after tonsillectomy compared to placebo.

METHODS

Adult subjects were randomized to 200 mg celecoxib versus placebo with a loading dose the night before surgery then twice daily for 10 days. Subjects were instructed to supplement the study drug with hydrocodone/acetaminophen liquid or acetaminophen for pain as needed. Subjects completed a daily diary regarding their pain, nausea, vomiting, diet, and activity.

RESULTS

Seventeen subjects enrolled. Intraoperative blood loss was similar between groups, and no subject had postoperative bleeding. Three patients returned to the emergency department for treatment, and 2 patients could not complete the diaries, all in the placebo group. Subjects in the placebo group required statistically significant (P < .05) higher doses of narcotic and acetaminophen to control pain. Pain and diet rating scores were slightly better in the celecoxib group compared to placebo.

CONCLUSIONS

In this small cohort, celecoxib reduced postoperative narcotic and acetaminophen requirements compared to placebo without complications.

摘要

目的

塞来昔布是一种环氧化酶-2特异性抑制剂,用于治疗急性疼痛以及骨关节炎和类风湿关节炎继发的疼痛。急性疼痛的手术模型已证明其止痛效果优于安慰剂。本研究的目的是比较塞来昔布与安慰剂用于扁桃体切除术后止痛的安全性和有效性。

方法

成年受试者被随机分为两组,一组服用200毫克塞来昔布,另一组服用安慰剂,术前一晚给予负荷剂量,然后每日两次,共10天。受试者被指导根据需要用氢可酮/对乙酰氨基酚液或对乙酰氨基酚补充研究药物以止痛。受试者完成一份关于其疼痛、恶心、呕吐、饮食和活动的每日日记。

结果

17名受试者入组。两组术中失血量相似,且无受试者术后出血。3名患者返回急诊科接受治疗,2名患者无法完成日记,均在安慰剂组。安慰剂组的受试者需要统计学上显著更高剂量的麻醉药和对乙酰氨基酚来控制疼痛。与安慰剂组相比,塞来昔布组的疼痛和饮食评分略好。

结论

在这个小队列中,与安慰剂相比,塞来昔布减少了术后麻醉药和对乙酰氨基酚的用量,且无并发症。

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