2023-506644-17-01已完成3 期
Comparison of cocaine, lidocaine/xylometazoline and saline for intranasal analgesia - A blinded triple crossover study
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Self reported pain felt during the procedure reported on a visual analogue scale of 0-100.
研究概览
简要总结
Comparison of cocaine, lidocaine/xylometazoline and saline for intranasal analgesia - A blinded triple crossover study
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 是
入选标准
- •Age 18 years or above
- •Proficient in spoken and written Danish
- •Healthy volunteers (no active diagnoses)
- •Negative hCG urine stix for women of childbearing potential
排除标准
- •Known nasal malformation
- •Known coagulopathy
- •Current antithrombotic treatment
- •Self-reported epistaxis occurring more than once a month
- •Symptoms of a common cold within the past week
研究组 & 干预措施
-
Experimental
Participants receiving -
干预措施: - (Drug)
结局指标
主要结局
Self reported pain felt during the procedure reported on a visual analogue scale of 0-100.
Self reported pain felt during the procedure reported on a visual analogue scale of 0-100.
次要结局
- Self reported pain felt after one minute of tolerating the nasal tube reported on a visual analogue scale of 0-100.
- Acoustic rhinometry measurement with the use of the RhinoScan SRE2000, Interacoustics A/S, Assens, Denmark.
- Video-evaluated assessment of the degree of vasoconstriction on the nasal mucosa.
- Saliva samples analyzed for cocaine’s main metabolite benzoylecgonine.
- Blood samples analyzed for cocaine.
研究者
Mo Haslund Larsen
Scientific
Rigshospitalet
研究点 (1)
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