Needle-Free Jet Injection of Lidocaine for Local Anesthesia During Lumbar Puncture: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Pain, Measured as Units on a Scale
研究概览
简要总结
Background: The J-Tip Device allows an intradermal needle-free jet injection of 1% buffered lidocaine. This study compares needle-free jet injection of lidocaine to saline in reducing pain prior to lumbar puncture in infants.
Methods: Randomized, double-blinded, placebo controlled trial involving infants, less than 3 months of age, presenting to the emergency department meeting clinical criteria for a lumbar puncture. All patients were administered the J-tip and randomized to either treatment with 1% lidocaine or an equivalent amount of sterile normal saline prior to lumbar puncture.
详细描述
Background: Lumbar puncture is an essential procedure in the emergency department for the evaluation of meningitis. Subcutaneous injection of lidocaine prior to lumbar puncture for local anesthesia is not a pain free procedure. The J-Tip Device allows an intradermal needle-free jet injection of 1% buffered lidocaine. This study compares needle-free jet injection of lidocaine to saline in reducing pain prior to lumbar puncture in infants.
Methods: Randomized, double-blinded, placebo controlled trial involving infants, less than 3 months of age, presenting to the emergency department meeting clinical criteria for a lumbar puncture. All patients were administered the J-tip and randomized to either treatment with 1% lidocaine or an equivalent amount of sterile normal saline prior to lumbar puncture. Vital signs were recorded during the procedure. Facial expressions as well as crying times were video recorded from start to finish. Independent reviewers assigned pain scores based on the validated Neonatal Facial Coding System with possible scores ranging from 0-5.
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
- Triple (Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- — 至 90 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •fever in infants less than 3 months
排除标准
- •toxic appearance, altered level of consciousness, age greater than 3 months or less than 4kg of weight
研究组 & 干预措施
Buffered lidocaine J-tip
Needleless injection of buffered lidocaine prior to lumbar puncture versus placebo (Normal saline)
干预措施: Buffered Lidocaine J-tip (Drug)
Normal saline J-tip
Needleless injection of normal saline (placebo) prior to lumbar puncture versus use of buffered lidocaine
干预措施: Buffered Lidocaine J-tip (Drug)
结局指标
主要结局
Pain, Measured as Units on a Scale
时间窗: on average the first hour in emergency department at 4 time points during entire lumbar puncture procedure.
Pain scores at time of needle insertion using neonatal facial coding score. The scale has five components; cry, brow bulge, eye squeeze; nasolabial fold and open month. Each component is either present or absent, with a value of 0 or 1 given. Minimum score of 0 and a maximum score of 5 possible
次要结局
- Length of Cry(On average the first hour in the emergency department; from needle stick to end of lumbar puncture)
研究者
Blake Bulloch
MD
Phoenix Children's Hospital