Assessment of the Efficacy of Anti-scorpion Venom Therapy in a Dose-response Manner, Following the Principles of Rational Drug Use in Patients With Scorpionism: a Non-inferiority, Randomized, Double-blind, Controlled Clinical Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- Time to resolution of signs and symptoms
研究概览
简要总结
The clinical study aims to compare the effectiveness of applying two different regimens of scorpion antivenom therapy. In the first regimen (control), the medication is administered to all patients, and depending on the severity of the condition, the dosage varies. In the experimental regimen, an identical dose of scorpion antivenom is administered to patients exhibiting signs and symptoms of scorpion sting intoxication, in addition to pain and other symptoms at the sting site. The primary response variable is the time taken for signs and symptoms to resolve, but differences in complications, adverse effects, venom and antivenom concentration in the blood, and the need for other therapeutic measures are also evaluated.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
A pharmacist will be responsible for randomizing the patients and preparing the study medication in a blinded manner, so that the treatment is administered by the physician without the care provider or the participant being able to identify it. The pharmacist will keep the randomization results in a sealed envelope that will be opened at the end of the study.
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Individuals aged 18 or older presenting with a diagnosis of scorpionism to the emergency department.
- •Treated solely with paracetamol, scorpion antivenom, saline solution, and local ice application.
- •Any gender.
- •Less than two hours elapsed since scorpion sting.
- •Willing to participate in the study through written informed consent.
排除标准
- •Allergies or contraindications to any of the study medications.
- •Uncertainty regarding scorpion sting.
- •Previous treatment by another physician.
- •Intramuscular administration of scorpion antivenom due to urgent clinical conditions.
- •Decision not to provide informed consent.
- •Any limitations hindering the proper understanding of study participation.
研究组 & 干预措施
Traditional scorpion antivenom regimen
Active/placebo comparator
干预措施: Traditional scorpion antivenom regimen (Drug)
Serial dose of scorpion antivenom regimen
干预措施: Serial dose of scorpion antivenom regimen (Drug)
结局指标
主要结局
Time to resolution of signs and symptoms
时间窗: two and a half to five hours
Time to resolution of signs and symptoms from admission and from the estimated time of the sting
Serum venom concentration
时间窗: two and a half to five hours
Serum venom concentration upon patient arrival, after administration of antivenom, and upon reporting the absence of signs of intoxication
次要结局
- Mortality(two and a half to five hours)
- Length of intrahospital stay(two and a half to five hours)
- Serum antivenom concentration(two and a half to five hours)
研究者
Selene Guadalupe Huerta Olvera
Professor and researcher
University of Guadalajara