NCT05648058尚未招募3 期
Role of Nefopam in Rituximab Transfusion Reaction
Ministry Of Health / Nineveh Health Directorate0 个研究点目标入组 100 人开始时间: 2022年12月20日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 主要终点
- transfusion reaction
研究概览
简要总结
the patients will be taken nefopam ampule 50 mg before rituximab in the first group while the second group will be taken diphenhydramine ampule 10 mg before rituximab in the second group
详细描述
the two groups will be taken standard therapy (hydrocortisone vial 100 mg and acetaminophen 1000 mg) 30 min before rituximab
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 - 80 years old male and female will be taken rituximab
排除标准
- •less than 18 years old more than 80 years old diabetic patients
研究组 & 干预措施
nefopam
Experimental
administration of intravenous nefopam to prevent Rituximab Transfusion Reaction
干预措施: Nefopam ampule (Drug)
diphenhydramine
Active Comparator
administration of intravenous diphenhydramine to prevent Rituximab Transfusion Reaction
干预措施: diphenhydramine ampule (Drug)
结局指标
主要结局
transfusion reaction
时间窗: 30 min
fever, riger, rash, chills, pruritus and bronchospasm
次要结局
未报告次要终点
研究者
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