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临床试验/NCT01837810
NCT01837810Unknown不适用

NSAID Post-Tonsillectomy Hemorrhage: A Randomized, Double-Blinded Controlled Noninferiority Trial

Brooke Army Medical Center3 个研究点 分布在 1 个国家目标入组 810 人开始时间: 2013年4月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
入组人数
810
试验地点
3
主要终点
clinically defined tonsil bleed rate (percentage)

研究概览

简要总结

The purpose of this study is to determine if ibuprofen use after electrocautery tonsillectomy increases the post-tonsillectomy hemorrhage rate.

Hypothesis: Use of ibuprofen does not increase the post-tonsillectomy hemorrhage rate.

Primary outcome: Rate of tonsillar hemorrhage following adult tonsillectomy in those receiving narcotic pain medications plus ibuprofen compared to those receiving narcotics alone.

Secondary outcome: Determine whether ibuprofen, a non-steroidal anti-inflammatory drug (NSAID), decreases post tonsillectomy pain, narcotic pain medication use, or cost of pain management.

详细描述

Tonsillectomy is common procedure associated with significant post-operative pain typically managed by narcotic pain medication. Narcotics, however, can have inherent unwanted side effects such as respiratory depression. In fact, a recent U.S. Food and Drug Administration (FDA) warning has reported deaths from respiratory distress that were associated with use of codeine in children after tonsillectomy. Finding alternative pain management regimens therefore is essential in post-tonsillectomy care. Non-steroidal anti-inflammatory (NSAID) medications may provide an effective alternative to narcotics, but use of NSAIDs routinely after tonsillectomy has been limited due to concern for theoretical increased risk of post-operative bleeding, This is likely true for NSAIDs such as aspirin. NSAIDs such as ibuprofen, however, are believed to have no greater risk of bleeding than baseline, but this has not been proven. Recent, well-designed, prospective pediatric studies have demonstrated effective analgesia improvement with the addition of non-steroidal anti-inflammatory drugs such as ibuprofen to post-operative pain management regimens, and no increased rate of post-surgery bleeding. This has not adequately been studied in adults but could provide many patients significant pain relief in the post-operative period if it is shown to not increase post tonsillectomy hemorrhage rates, as already demonstrated in the pediatric population.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Triple (Participant, Care Provider, Investigator)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adults 18 years old or older
  • Scheduled for tonsillectomy

排除标准

  • Prisoners
  • Pregnancy
  • Allergy to ibuprofen
  • History of vasculopathy to include Lupus or Wegener's or Disseminated Intravascular Coagulation (DIC)
  • Any other bleeding disorder to include Von Willebrand Disease and others
  • Active Neoplasm of any kind
  • Tonsillectomy in combination with any sleep surgical procedure or palatal procedure

研究组 & 干预措施

Ibuprofen

Experimental

800mg ibuprofen every 8 hours prn pain.

干预措施: Ibuprofen (Drug)

结局指标

主要结局

clinically defined tonsil bleed rate (percentage)

时间窗: 2 weeks

A post tonsillectomy hemorrhage/bleed, for the purposes of this study, is defined as a postoperative bleed requiring anything more than medicinal intervention (cauterization of any kind, suture, evaluation in operating room).

次要结局

  • Hospital readmission rate (percentage)(2 weeks)
  • Subclinical (not requiring intervention) subjectively reported tonsil bleed rate (percentage)(2 weeks)
  • Pain scale rating(2 Weeks)
  • Nausea Scale(2 weeks)

研究者

申办方类型
Fed
责任方
Principal Investigator
主要研究者

Gregory R. Dion

MD, MS, CPT, MC, USA

Brooke Army Medical Center

研究点 (3)

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