NCT00270777已完成4 期
Low Dose Adrenaline, Promethazine, & Hydrocortisone (Alone and in Combination) to Prevent Acute Adverse Reactions to Antivenom in People Bitten by Snakes: Randomised, Double Blind, Placebo-Controlled Trial
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- Frequency of severe reactions to antivenom in the first 48 hours
研究概览
简要总结
A study to increase the safety of polyvalent antivenom involving 1000 patients in three centres: low dose adrenaline, promethazine, & hydrocortisone (alone and in combination) to prevent acute adverse reactions to antivenom in people bitten by snakes: randomised, double blind, placebo-controlled trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Double
入排标准
- 年龄范围
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Above 12 years of age
- •Patients admitted to hospital after snake bite in whom antivenom is indicated
- •Patients who give informed consent
排除标准
- •Patients who are pregnant or nursing
- •Patients who are currently taking beta- or alpha-adrenoceptor antagonists, or tricyclic antidepressants
- •Patients in whom adrenaline may be contraindicated (this may include patients with the following: history of ischaemic heart disease, stroke, uncontrolled hypertension, and tachyarrhythmias)
结局指标
主要结局
Frequency of severe reactions to antivenom in the first 48 hours
次要结局
- Frequency of moderate & severe reactions to antivenom in the first 48 hours
研究者
研究点 (1)
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