NCT04184349已完成4 期
Truncal Ultrasound Guided Regional Anesthesia for Implantation and Revision of AICDs and Pacemakers in Pediatric Patients
The University of Texas Health Science Center, Houston1 个研究点 分布在 1 个国家目标入组 19 人开始时间: 2020年10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
- 状态
- 已完成
- 入组人数
- 19
- 试验地点
- 1
- 主要终点
- Total Narcotic Dose in Milligram Morphine Equivalents (MME) Per Kilogram
研究概览
简要总结
The purpose of this study is to determine the efficacy and safety of truncal blocks for pacemaker and Automatic Implantable Cardioverter Defibrillator implantation in children and to prospectively evaluate whether there is a decrease in amount of narcotic medications need and track complications.
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
- None
入排标准
- 年龄范围
- 0 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients undergoing implantation or revision of pacemaker or AICD in the pediatric cath lab
排除标准
- •parent or patient refusal
- •use of narcotic medications prior to procedure
研究组 & 干预措施
Local Anesthetic (LA Group)
Active Comparator
干预措施: LA group (Drug)
B group
Active Comparator
干预措施: B Group (Drug)
结局指标
主要结局
Total Narcotic Dose in Milligram Morphine Equivalents (MME) Per Kilogram
时间窗: up to 24 hours after procedure
次要结局
- Pain as Measured by the Visual Analog Scale (VAS) Pain Score(up to 24 hours post procedure)
- Pain as Measured by the Face, Legs, Activity, Cry, Consolability (FLACC) Pain Assessment Scale(up to 6 hours post procedure in post anesthesia care unit (PACU))
- Number of Patients With the Incidence of Pruritis(up to 48 hours after procedure)
- Number of Patients With the Incidence of Nausea/Vomiting(up to 48 hours after procedure)
- Number of Patients With Respiratory Depression(up to 48 hours after procedure)
- Number of Patients With Local Anesthetic Toxicity(up to 48 hours after procedure)
- Number of Patients With Incidence of Pneumothorax(up to 48 hours after procedure)
研究者
Olga Pawelek
Associate Professor
The University of Texas Health Science Center, Houston
研究点 (1)
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