NCT00755989撤回不适用
A Phase 3, Single-centered, Randomized, Double-blind, Placebo-controlled, Efficacy and Safety Trial of Morphine Sulfate Gel 0.1% in Patients With Stage 2-3 Wounds
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Safety and efficacy with the use of morphine gel applied topically for pain control
研究概览
简要总结
Morphine gel applied topically to wounds will reduce wound pain and decrease patients use of oral and intravenous pain medications, therefore reducing side effects.
详细描述
Patients will be randomized to receive either placebo (versa base gel) or morphine gel to wound. Patients receiving morphine gel will have a decrease in pain score and use less oral/intravenous pain medications.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- Double (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed and dated consent form & HIPAA
- •>/= 18 yo
- •Single stage 2-3 wound evaluated by our wound care team
- •Alert and oriented (thinking ability clear and intact, physician approval)
- •English language proficiency, likely to be able to participate in all scheduled evaluations
排除标准
- •Allergy to morphine, codeine, or versa base
- •pts taking medications for acute condition, other than for the wound pain (can be taking chronic pain meds if current dose stable for past 3 mo)
- •Patients with neuropathies
- •Patients with respiratory conditions
- •Patients that are pregnant
结局指标
主要结局
Safety and efficacy with the use of morphine gel applied topically for pain control
时间窗: 1 year
次要结局
未报告次要终点
研究者
研究点 (2)
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