NCT03421275Unknown4 期
Intranasal Fentanyl and Esketamine for Treatment of Acute Pain in Minor Trauma Patients
Anna Meuronen, MD1 个研究点 分布在 1 个国家目标入组 105 人开始时间: 2017年12月1日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 105
- 试验地点
- 1
- 主要终点
- Numeric rating scale (NRS) change
研究概览
简要总结
Intranasal esketamine, fentanyl and placebo are compared in treatment of acute pain in adult patients with minor trauma. Study is blinded randomized placebo-controlled parallel design.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •NRS 5 or more, minor trauma, no need for immediate iv cannulation, weight 45-115 kg
排除标准
- •pregnancy, breastfeeding, head trauma, severe chronic obstructive pulmonary disease (COPD), gfr under 30, liver cirrhosis, mental illness other than mild/moderate depression, sleep apnea, unstable coronary artery disease (CAD), unstable heart failure (HF), intoxication, untreated hypertension, dementia, do not understand Finnish, contraindication to nasal spray, allergy to any of the medications, bradycardia, desaturation, suspected high intracranial pressure (ICP)
研究组 & 干预措施
Esketamine
Experimental
intravenous anaesthetic and analgetic
干预措施: Esketamine (Drug)
Fentanyl Citrate
Active Comparator
intravenous opioid analgetic
干预措施: Fentanyl Citrate (Drug)
Saline Nasal
Placebo Comparator
intravenous "Natriumklorid b. Braun 9 mg/ml"
干预措施: Saline Nasal (Drug)
结局指标
主要结局
Numeric rating scale (NRS) change
时间窗: 15 minutes and 30 minutes
Numeric rating scale is used to measure pain intensity. Scale is from 0-10. 0 = no pain, 10 = worst imegeable
次要结局
- Amount of patients with NRS change more than -2(15 min, 30 min, 60 min)
- Patient satisfaction (pain management)(120 min)
- Need for rescue medication mg (oxycodone)(120 min)
- Side effects(120 min)
- Amount of study drug consumed (doses)(120 min)
研究者
Anna Meuronen, MD
Principal Investigator
Hospital District of Helsinki and Uusimaa
研究点 (1)
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