Comparison of iv Paracetamol, iv Dexketoprofen and Topical Lidocaine in Scorpion Sting: a Placebo Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 106
- 试验地点
- 1
- 主要终点
- Change of the intensity of pain
研究概览
简要总结
In scorpion stings, patients mostly apply with the complaint of pain. Emergency physicians need to relieve this pain quickly.
详细描述
Aim: In this study, the analgesic efficacy of intravenous (IV) paracetamol, IV dexketoprofen trometamol and topical lidocaine will be compared in patients presenting with pain after scorpion sting.
Methods: This study is a double-blind, randomized, placebo-controlled study conducted in a tertiary emergency department. Adult patients who applied to the study with no systemic findings after scorpion sting and especially with pain will be randomly assigned to one of 4 groups: IV paracetamol, IV dexketoprofen trometamol, topical lidocaine or placebo. In order to determine the intensity of pain, Visual Analog Pain Score (VAS) will be measured at the time of admission to the emergency department, at the 30th minute and at the 60th minute. Afterwards, the VAS score changes between the groups will be compared.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 18 and over
- •Scorpion sting with pain
- •The diagnostic criteria of Grade 1 for Scorpion sting
排除标准
- •Patients who denied to give informed consent
- •Taking analgesic treatment (ice application or drugs etc.) in the last 6 hours
- •Any symptoms and findings of systemic toxicity of scorpion sting
- •Pregnant women
- •Hemodynamically unstable patients
- •Known allergy to drugs of the study
- •Patients with renal disease
- •The cases that passed more than 6 hours after the bite
研究组 & 干预措施
paracetamol
1000 mg intravenous paracetamol
干预措施: paracetamol (Drug)
Dexketoprofen Trometamol
50 mg intravenous Dexketoprofen Trometamol
干预措施: Dexketoprofen Trometamol (Drug)
topical lidocaine
%5 lidocaine 5 gr topical
干预措施: Lidocaine topical (Drug)
placebo
100 mL intravenous normal saline+ placebo topical pomade
干预措施: Placebo (Drug)
结局指标
主要结局
Change of the intensity of pain
时间窗: 30 minutes and 60 minutes after the study drug administered
Pain intense will be measured by 100 mm visual analog scale (Zero; no pain and 100 mm; the worst pain) after 30th and 60th minutes later after the study drug administered
次要结局
- Adverse events(60 minutes after the study drug administered)
- need to rescue medication(60 minutes after the study drug administered)
研究者
Umut Gulacti
Adiyaman University Medical Faculty of Research and Training Hospital
Adiyaman University Research Hospital