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临床试验/NCT00799149
NCT00799149已完成4 期

Phase 4 Study Comparing the Efficacy of Etoricoxib Versus Gabapentin as Part of a Multimodal Analgesic Regimen for Ambulatory Knee Arthroscopy

Meir Medical Center1 个研究点 分布在 1 个国家目标入组 75 人开始时间: 2006年6月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
入组人数
75
试验地点
1
主要终点
1)Pain intensity (as assessed using a 100 visual analog scale) 2)Incidence of dipyrone usage

研究概览

简要总结

To determine that when administered as part of a multimodal analgesic regimen, use of the new COX-2 antagonist etoricoxib (120 mg/day, per os) is more effective in improving postoperative pain management after knee arthroscopy than gabapentin (1.2 g/day, per os).

详细描述

Background: Post-discharge pain remains a significant problem after many ambulatory surgery procedures. Both etoricoxib and gabapentin have been used to prevent postoperative pain; however their relative efficacy in the post-discharge period is not known. We hypothesized that daily use of etoricoxib would offer advantages over gabapentin as part of a multimodal analgesic regimen in the perioperative period due to its pharmacokinetic profile.

Methods: Seventy-five healthy outpatients undergoing elective ambulatory knee arthroscopy were randomly assigned to receive identical-appearing capsules containing either a placebo, gabapentin (1.2g, or etoricoxib 120 mg, 30-90 min before skin incision and at 08H00 on the first, second, and third postoperative days. Post-discharge pain was treated with "rescue" dipyrone syrup (500 mg). Pain intensity (as assessed using a 100 visual analog scale), dipyrone usage, and the incidence of nausea and vomiting, sedation and anxiety were recorded at specific time intervals in the postoperative period. The recovery of functional activity was assessed at 96 h after surgery using a validated questionnaire.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

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

  • Elective ambulatory knee arthroscopy

排除标准

  • History of clinically-significant cardiovascular,pulmonary,hepatic,renal, neurologic, psychiatric or metabolic disease
  • Patients chronically receiving pain killers

研究组 & 干预措施

Gabapentin

Active Comparator

Gabapentin (1200 mg) administered 30-90 min before the patient entered the operating room; Subsequent doses of Gabapentin (1200 mg)were administered on the mornings (08H00) of the first, second, and third postoperative days.

干预措施: Gabapentin, Etoricoxib, Sugar pill (Drug)

Etoricoxib

Active Comparator

Etoricoxib (120 mg)administered 30-90 min before the patient entered the operating room; Subsequent doses of etoricoxib (120 mg)were administered on the mornings (08H00) of the first, second, and third postoperative days.

干预措施: Gabapentin, Etoricoxib, Sugar pill (Drug)

Sugar pill

Placebo Comparator

Sugar pill administered 30-90 min before the patient entered the operating room. Subsequent doses of Sugar pill were administered on the mornings (08H00) of the first, second, and third postoperative days.

干预措施: Gabapentin, Etoricoxib, Sugar pill (Drug)

结局指标

主要结局

1)Pain intensity (as assessed using a 100 visual analog scale) 2)Incidence of dipyrone usage

时间窗: 96 hours post-operation

次要结局

  • The recovery of functional activity(96 hours)

研究者

申办方类型
Other

研究点 (1)

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