Pain Control Alternatives in Pediatric Patients With Distal Radius Fractures
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Pain control efficacy
研究概览
简要总结
The aim of this study is to evaluate the efficacy of a hematoma block and minimal ketamine pain control or hematoma block and intranasal fentanyl in pediatric patients presenting with distal radius fractures requiring reduction, compared to control of standard full conscious sedation using ketamine.
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
- 3 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children requiring reduction for distal radius fracture
- •Children presenting to the emergency department
- •Children who are ages 3 to 17 years.
排除标准
- •Pediatric patients <3 years old
- •Adult patients (i.e. ages 18 or up)
- •Pediatric patients with injury patterns that are not amenable to hematoma block.
- •Children who are not a candidate for sedation related to BMI > 95%tile for age, ASA class > 2, Mallampati score > 2, and pregnant patients
研究组 & 干预措施
Full ketamine sedation
Including group of patients treated with full ketamine sedation in setting of distal radius fracture reduction
干预措施: Ketamine group (Drug)
Hematoma block/minimal ketamine pain control
Including group of patients treated with hematoma block/minimal ketamine pain control (. 0.25mg/kg) for distal radius fracture reduction in pediatric patients requiring reduction
干预措施: Ketamine + Lidocaine (Drug)
hematoma block/intranasal fentanyl
Including control group of patients treated with intranasal fentanyl and hematoma block, utilized in the setting of distal radius fractures in pediatric patients requiring reduction
干预措施: Fentanyl (Nasalfent, Fentanyl Citrate Nasal Spray) (Drug)
结局指标
主要结局
Pain control efficacy
时间窗: 1 hour after fracture reduction is complete on the day of the procedure/study visit.
Including control group of patients treated with full ketamine sedation in setting of distal radius fracture reduction; randomization of patients deemed safe for full sedation to either control group, or one of two intervention groups including (group 1) hematoma block/minimal ketamine pain control (0.25mg/kg), and (group 2) intranasal fentanyl and hematoma block, utilized in the setting of distal radius fractures in pediatric patients requiring reduction. The investigators will be obtaining Visual Analog Scale (VAS) pain scores for each group to determine pain control efficacy and to compare between groups. This is a numeric pain scale with associated faces to help children determine their pain level, with 0 being "no pain" (with a smiley/happy face) and 10 being "most pain possible" (with a sad/crying face).
Patient satisfaction scores
时间窗: 1 hour after fracture reduction is complete on the day of the procedure/study visit.
Including control group of patients treated with full ketamine sedation in setting of distal radius fracture reduction; randomization of patients deemed safe for full sedation to either control group, or one of two intervention groups including (group 1) hematoma block/minimal ketamine pain control (0.25mg/kg), and (group 2) intranasal fentanyl and hematoma block, utilized in the setting of distal radius fractures in pediatric patients requiring reduction. The investigators will be obtaining patient satisfaction scores via a 5-point Likert scale to compare patient satisfaction between groups.
次要结局
未报告次要终点
研究者
Tara Petroski
Principal Investigator
State University of New York at Buffalo