2024-518816-38-00招募中4 期
Intranasal dexmedetomidine sedation and analgesia during minor procedures in the pediatric emergency room: Randomized double-blinded clinical trial
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 112
- 试验地点
- 1
- 主要终点
- The success of the procedure at the first attempt
研究概览
简要总结
Our objective is to determine if intranasal dexmedetomidine is a safe and effective sedative drug during small painful procedures in the pediatric emergency room.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 0 years 至 17 years（0-17 Years）
- 接受健康志愿者
- 是
入选标准
- •Age 1-12 years
- •Small procedure (e.g. i.v. cannulation or lumbar puncture)
- •Presents at the Oulu University Hospital emergency room
排除标准
- •Allergy to dexmedetomidine or any supplementary elements of the dexmedetomidine-solution
- •II or III degree AV-blockage without pacemaker
- •Uncontrollable hypotension
- •Critically ill patients who are admitted to the Pediatric Intensive Care Unit
- •Patients with clear cardiac or respiratory dysfunction
- •Lowered level of consciousness
- •Patients with increased risk of apnoeic events due to neurologic or metabolic conditions or extreme obesity
- •Prior participation to the current study
结局指标
主要结局
The success of the procedure at the first attempt
The success of the procedure at the first attempt
次要结局
- The duration of the procedure
- Parents assessment of the patients comfortability during the procedure
- Patient's and physician's assessment of the experienced pain with Visual Analog Scale
- Assessment of pain levels of the patient with FLACC-scores
- Assessment of sedation levels of the patient with Comfort-B-scores
- Duration of crying
- The parents and the emergency room nurses are asked whether they think the patient recieved the experimental drug or placebo
- Blood pressure measured by manometer
- Respiratory rate assessed by capnometry
- Oxygen saturation is measured by pulse oxymetry
- Heart rate measured by ECG
研究者
The university help desk
Scientific
Oulu University Hospital
研究点 (1)
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