Midazolam Sedation for Neonatal Lumbar Puncture in the Emergency Department: A Randomized Controlled Trial
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- The Simplified Neonatal Facial Coding System will be used for assessment of pain. Scoring will be composed from four specific facial actions (brow bulge, nasolabial furrow, eye squeeze, and open mouth) and the presence or absence of crying
研究概览
简要总结
Lumbar puncture is one of the most common painful procedures performed on neonates in the Emergency Department (ED). The investigators will study in a randomized controlled trial, the efficacy of intravenous administration of a single dose of Midazolam in reducing pain and anxiety in neonates undergoing lumbar puncture in the ED, as well as the rate of adverse sedation reactions. The investigators hypothesize that compared with placebo, single dose Midazolam would significantly decrease pain and anxiety and will have low rate of adverse reactions.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 3 Days 至 30 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •American Society of Anesthesiologists (ASA) score I, II
- •Post natal age ≤ 30 days
- •Fasting of at least 2 hours before the procedure
排除标准
- •American Society of Anesthesiologists (ASA) score III or greater
- •Gestational age of 37 weeks or younger
- •Congenital disease or defect
- •Any medication provided by the caregiver prior ED admission
- •Fasting of less than 2 hours
研究组 & 干预措施
Midazolam
Administration of Midazolam prior Lumbar Puncture
干预措施: Midazolam (Drug)
结局指标
主要结局
The Simplified Neonatal Facial Coding System will be used for assessment of pain. Scoring will be composed from four specific facial actions (brow bulge, nasolabial furrow, eye squeeze, and open mouth) and the presence or absence of crying
时间窗: 20 seconds prior lumbar puncture, during needle insertion, and 20 seconds post insertion
次要结局
- Physician's level of satisfaction from the procedural conditions(Five minutes post successful LP)
- LP Success rate(Five minutes post successful LP)
- Adverse sedation reactions(During procedure and during recovery phase)
研究者
i_shavit
Pediatric Emergency Department director
Rambam Health Care Campus