A Pilot Study to Determine the Pruritic Benefits of Ondansetron Versus Diphenhydramine in Burn Patients Undergoing Wound Healing
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Ondansetron will have a greater ability to control pruritus in burn patients who are undergoing wound healing when compared to the standard of care, diphenhydramine.
研究概览
简要总结
The purpose of this study is to see if a drug called ondansetron (Zofran) controls itching from healing burn wounds as well or better than the usual drug used, diphenhydramine (Benadryl).
详细描述
A clear mechanism or cause for pruritus in patients recovering from burn has not been delineated.
While the exact mechanisms/pathways for itching are currently unclear, histamine antagonism appears to be the most popular treatment. Whether histamine antagonism works predominantly via peripheral inhibition or central sedation is uncertain. By treating another intermediary in the pruritus cascade, it may be possible that an alternate treatment could be used while eliminating some of the unwanted side effects of antihistamine at the same time.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 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
- 否
入选标准
- •Males or females; 18 years or older.
- •Seen in the United States Army Institute of Surgical Research (USAISR) Burn Clinic with healing burn wounds of any percent (%) of total body surface area (TBSA) causing pruritus
- •Stable medical condition
- •Negative pregnancy test and not nursing
- •Able to indicate status of pruritus on a numeric scale
- •Able to understand and read English
排除标准
- •Unstable medical condition as determined by attending burn surgeon
- •History of allergic reaction to serotonin inhibitors or diphenhydramine
- •Pregnant or lactating
- •Unable to verbalize pruritus intensity scale
- •Unable to understand or read English
研究组 & 干预措施
2
干预措施: Ondansetron (Zofran) (Drug)
2
干预措施: Diphenhydramine (Benadryl) (Drug)
结局指标
主要结局
Ondansetron will have a greater ability to control pruritus in burn patients who are undergoing wound healing when compared to the standard of care, diphenhydramine.
时间窗: 14 days
次要结局
未报告次要终点