跳至主要内容
临床试验/NCT02856750
NCT02856750已完成早期 1 期

A Multicenter, Randomized Controlled Trial of the Efficacy of Gabapentin vs. Placebo for Adjuvant Pain Control Following Acute Rib Fractures

Denver Health and Hospital Authority1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2016年10月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
早期 1 期
状态
已完成
入组人数
100
试验地点
1
主要终点
Average Daily Pain Score

研究概览

简要总结

A Multi-center, Randomized Controlled Trial of the Efficacy of Gabapentin vs. Placebo for Adjutant Pain Control Following Acute Rib Fractures.

详细描述

Traumatic rib fractures are a tremendous source of pain which can limit respiratory function and overall recovery. Numerous multimodal pain management strategies have been employed with varying success; however, narcotics remain the mainstay of treatment. Beyond the acute side effects of narcotics, including altered mental status, depression of respiratory drive, and constipation, there is a substantial risk of long term dependency. Recently, loco-regional blockade and non-narcotic adjuncts have received increasing support within the literature. Gabapentin has been used extensively as a non-narcotic adjunct to analgesia regimens in the acute and chronic settings, however its ability to better control pain secondary to traumatic rib fractures has never been studied .

The primary aim is to assess the efficacy of gabapentin as an analgesic after rib fractures. Secondary aims are to assess the effect on pulmonary function and other known complications following rib fractures.

The hypothesis is gabapentin will improve pain control as measured by lower pain scores and lower narcotic needs. The investigators plan to test this hypothesis by recruiting trauma patients with rib fractures, and randomly assign them to gabapentin versus a placebo.

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
Triple (Participant, Care Provider, Investigator)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • > 1 rib fractures
  • Requiring hospital admission
  • Enrolled within 24 hours of injury

排除标准

  • Pregnancy
  • Intubation
  • Age <18, age >65
  • Inability to tolerate PO medication
  • Patient refusal
  • Inability to obtain consent from patient or surrogate
  • Renal or Hepatic impairment
  • Allergy or Hypersensitivity to gabapentin or any component of the formulation

研究组 & 干预措施

gabapentin

Experimental

gabapentin 300 mg three times daily x 30 d

干预措施: Gabapentin (Drug)

结局指标

主要结局

Average Daily Pain Score

时间窗: 30 days

the pain score uses the visual analog scale and ranges from 0 to 10. This is recorded by nursing at pre-specified intervals depending on level of care.

次要结局

  • Narcotic requirements(30 days)
  • pulmonary function(30 days)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验