EUCTR2018-002606-31-DE进行中（未招募）1 期
Sublingual versus intravenous Fentanyl in patients with acute trauma - a randomized, double-blind, double-dummy study to demonstrate non-inferiorityTraumaPACT
Ruprecht-Karls-University Heidelberg, Medical Faculty represented by Universitätsklinikum Heidelberg and its Commercial0 个研究点目标入组 340 人开始时间: 2019年1月30日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 340
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •- Age 18-65 years
- •- isolated or combined, non-head trauma
- •- Intravenous access indicated
- •- Glasgow Coma Scale(GCS) score (aggregate of verbal, eye, and motor response scores) of 15 (no disturbance of consciousness)
- •- Stable circulation (blood pressure, pulse) at the discretion of the investigator
- •- Oxygen saturation of at least 95%
- •- Numeric pain rating scale (NRS, 5-10) = 5
- •- Ability of subject to understand character and individual consequences of the clinical trial
- •- Patient (deferred) consent to treatment
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 340
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •- Pre-treatment with potent opioid-analgesics within 30 days prior to acute trauma
- •- (obvious) pregnancy or lactation
- •- Nasopharyngeal injuries
- •- Obstructive lung disease
- •- Foreseeable indication for endotracheal intubation
- •- Nausea or vomiting expected
- •- History of hypersensitivity to the investigational medicinal product or to any drug with similar chemical structure or to any excipient present in the pharmaceutical form of the investigational medicinal product
- •- legally incapacitated
研究者
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