"Lidocaine 4% Cream (LMX4) vs Placebo for Pain Due to Lumbar Puncture in Infants 0-60 Days of Age."
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Neonatal Facial Coding System Score
研究概览
简要总结
The study's hypothesis is LMX4 cream, a topical anesthetic cream, will reduce the pain of infants undergoing Lumbar Puncture (spinal tap).
详细描述
Pain of infants will be measured using the Neonatal Facial Coding System by videotaping the infant's face while they undergo the procedure. A comparison between the group that received active drug and the group that received placebo will allow a measurement of the difference, if any, of the pain experienced during the procedure of the infants.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 0 Days 至 60 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Full term (>=37 weeks gestation)
- •Age 0-60 Days
- •Undergoing Lumbar Puncture
排除标准
- •Premature (<37 weeks gestation)
- •Allergy to study medicine
- •Parent refusal of consent
研究组 & 干预措施
Active Drug
Active 4% Lidocaine topical cream (LMX4 cream) applied under occlusive dressing
干预措施: Lidocaine Cream 4% (Drug)
Placebo
Placebo Cream made on same run at factory but without active Lidocaine 4% drug
干预措施: Placebo (Drug)
结局指标
主要结局
Neonatal Facial Coding System Score
时间窗: Score was measured at baseline, upon positioning for the procedure, immediately prior to needle insertion, during needle insertion, 1 minute post-needle insertion, and post-procedure when the infant had recovered from the procedure and was swaddled
10 measures of pain, all scored 0 or 1, high score means more pain. No pain would be recorded as zero, maximum pain recorded as 10
次要结局
- Time of Procedure(Infant's stay in the Emergency Department)
- Percentage of Procedures With Success(During patient's Emergency Department Stay)
研究者
James Reingold
Principal Investigator
State University of New York at Buffalo