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