Needle-Free Jet Injection Versus Traditional Lidocaine Needle Infiltration for Local Anesthesia in Infant Lumbar Puncture
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Pain Score
研究概览
简要总结
We hypothesize that the J-Tip needle-free jet-injection system offers comparable pain control and greater provider satisfaction due to its less invasive nature compared to traditional needle infiltration of 1% lidocaine in infants undergoing lumbar punctures.
Our aim is to evaluate the efficacy and feasibility of different local anesthetic techniques in the ED setting by comparing traditional lidocaine needle infiltration with J-tip.
详细描述
Lumbar punctures (LPs) play a key role in diagnosing meningitis in febrile infants. The use of local anesthesia is critical to the success of these procedures. Traditional anesthesia techniques, including needle injections and the application of topical anesthetic creams, have been effective in managing pain and enhancing the outcomes of LPs. Recently, the introduction of needle-free jet injection technology, such as the J-Tip system, offers a quicker and less invasive method for delivering local anesthesia.
This research compares the effectiveness of the J-Tip with that of traditional 1% lidocaine infiltration for local anesthesia during LPs in infants.
The investigators hypothesize that the J-Tip needle-free jet-injection system offers comparable pain control and greater provider satisfaction due to its less invasive nature compared to traditional needle infiltration of 1% lidocaine in infants undergoing lumbar punctures.
The aim is to evaluate the efficacy and feasibility of different local anesthetic techniques in the ED setting by comparing traditional 1% lidocaine needle infiltration with administration of 1% lidocaine the J-Tip.
Secondary outcomes include the number of attempts to successfully perform the LP, perceptions of pain management effectiveness by ED providers, the need for additional lidocaine, skin condition at the LP site, and the overall success rate of the LP procedures.
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
- 1 Day 至 3 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •Infants with known allergy or hypersensitivity to lidocaine or components of the needle-free jet injection device
- •Infants with significant skin infection or dermatitis at the site of injection
- •Infants with coagulopathy or any bleeding disorder
- •Infants with any other condition that, in the opinion of the investigator, would make participation in the study unsafe or not in the best interest of the infant
结局指标
主要结局
Pain Score
时间窗: Immediately post-procedure (within 5 minutes after the lumbar puncture)
The primary outcome measure will be the pain score of infants undergoing lumbar punctures, assessed using a validated pain scale appropriate for infants.
Procedure Success Rate
时间窗: During the procedure
The success rate of the lumbar puncture procedure, defined as obtaining an adequate CSF sample on the first attempt without the need for additional anesthesia.
Caregiver Satisfaction
时间窗: Within 1 hour post-procedure
Caregiver satisfaction with the anesthesia method used, measured using a standardized survey or questionnaire completed after the procedure.
次要结局
未报告次要终点