NCT05947292已完成不适用
PLEXUS (Pediatric Lower Extremity Ultrasound-Guided Nerve Block) Study: A Prospective, Multi-center, Observational Study Comparing Ultrasound Guided Fascia Iliaca Compartment Nerve Block to Systemic Analgesia for Femur Fractures in the Pediatric Emergency Department
Zachary Binder10 个研究点 分布在 2 个国家目标入组 114 人开始时间: 2022年6月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 114
- 试验地点
- 10
- 主要终点
- 60 Minute Pain Score
研究概览
简要总结
The goal of this prospective observational study is to compare pain control strategies in children with femur fractures. Researchers will compare ultrasound-guided fascia iliaca compartment nerve block to IV pain control alone. The main questions it aims to answer are:
- Are ultrasound-guided fascia iliaca compartment nerve blocks as effective as IV pain control in controlling pain?
- Do patients who receive an ultrasound-guided fascia iliaca compartment nerve block require less opioid pain medication than those that don't?
Participants will be asked to provide pain scores during their Emergency Department stay. Participants parents will be asked to complete a brief survey at the time their child is leaving the Emergency Department.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 4 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Acute femur fracture (less than 24 hours from initial injury)
- •Glasgow Coma Scale of 14 or greater at time of enrollment
排除标准
- •Allergy or hypersensitivity to local anesthetic agents
- •Neurovascular injury to the affected limb
- •Bilateral femur fractures
- •Confirmed, or significant clinical suspicion for, injury to their head, neck, chest, abdomen, back or pelvis
- •Imaging suggestive of a head, neck, chest, abdomen, back or pelvic injury
- •Laboratory results suggestive of a head, neck, chest, abdomen, back or pelvic injury
- •A fracture not limited to the extremities (i.e. vertebral compression fracture)
- •A significantly displaced extremity fractures (aside from the primary femur fracture)
- •An open fracture (aside from the primary femur fracture)
- •An additional fracture to the limb of the primary femur fracture (i.e. tibia fracture in the same leg as the primary femur fracture).
结局指标
主要结局
60 Minute Pain Score
时间窗: 60 minutes after enrollment.
Self reported pain score using the Faces Pain Scale-Revised. Values range from 1-10 (10 means a worse outcome).
次要结局
- Parental Satisfaction(From admission to the emergency department to discharge from the emergency department, up to 72 hours.)
- Oral Morphine Equivilents(From admission to the emergency department to hospital discharge, up to 72 hours.)
- Percentage of Patients Experiencing Adverse Events(From admission to the emergency department to hospital discharge, up to 72 hours.)
- 240 Minute Pain Score(240 minutes after enrollment.)
研究者
Zachary Binder
Assistant Professor
University of Massachusetts, Worcester
研究点 (10)
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