A Randomized, Double Blind Trial of Pediatric Lumbar Puncture Under Sedation/Total Intravenous Anesthesia (TIVA) With and Without EMLA Cream
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 33
- 试验地点
- 1
- 主要终点
- Total Dose of Propofol Administered to Each Patient
研究概览
简要总结
This randomized clinical trial studies local anesthetic (EMLA) cream in younger patients undergoing lumbar punctures (LP). A local anesthetic cream may be effective for numbing the skin and reducing movement when applied prior to lumbar punctures and may reduce the amount of sedation necessary
详细描述
PRIMARY OBJECTIVES:
I. To determine whether the application of a topical anesthetic (EMLA cream) to the LP site will decrease the total dose of propofol administered to pediatric oncology patients who are being sedated for LPs compared to application of a topical placebo cream.
SECONDARY OBJECTIVES:
I. To determine whether the use of EMLA cream decreases complication rates from sedation.
II. To determine whether the use of EMLA cream decreases traumatic lumbar punctures.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- — 至 22 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pediatric oncology patients undergoing a lumbar puncture in the Pediatric Sedation Suite; patients may or may not be receiving intrathecal chemotherapy
排除标准
- •Patients undergoing additional procedures during the same anesthetic such as bone marrow aspirate or biopsy will be excluded because they will likely require higher doses of propofol than those undergoing LP alone Patients who are allergic to or not tolerant of EMLA cream, propofol, or fentanyl will be excluded Patients who are pregnant will be excluded Patients having their LPs done by students will be excluded
研究组 & 干预措施
Arm I (EMLA)
Patients receive topical EMLA cream 60 minutes to 4 hours prior to the LP followed by standard sedation with fentanyl citrate and propofol.
干预措施: EMLA (Drug)
Arm I (EMLA)
Patients receive topical EMLA cream 60 minutes to 4 hours prior to the LP followed by standard sedation with fentanyl citrate and propofol.
干预措施: propofol (Drug)
Arm I (EMLA)
Patients receive topical EMLA cream 60 minutes to 4 hours prior to the LP followed by standard sedation with fentanyl citrate and propofol.
干预措施: fentanyl citrate (Drug)
Arm II (placebo)
Patients receive topical placebo cream 60 minutes to 4 hours prior to the LP followed by standard sedation with fentanyl citrate and propofol.
干预措施: placebo administration (Drug)
Arm II (placebo)
Patients receive topical placebo cream 60 minutes to 4 hours prior to the LP followed by standard sedation with fentanyl citrate and propofol.
干预措施: propofol (Drug)
Arm II (placebo)
Patients receive topical placebo cream 60 minutes to 4 hours prior to the LP followed by standard sedation with fentanyl citrate and propofol.
干预措施: fentanyl citrate (Drug)
结局指标
主要结局
Total Dose of Propofol Administered to Each Patient
时间窗: 20 minutes after sedation
Analyzed using descriptive statistics and mixed model regression methods. Raw mean total dose administered and raw percentage of times additional propofol was administered will be presented by sedation group treating each event (sedation with lumbar puncture) as the unit. T-test and chi-square tests will be performed as appropriate.
次要结局
- Complications Including Any Change in Vital Signs That Requires Intervention by the Sedation Team, as Well as Post-LP Headache From Sedation With or Without EMLA Cream(Within one week of the LP)
- Traumatic Lumbar Punctures After EMLA Cream or Placebo Cream Administration(20 minutes after lumbar puncture)
- Level of Movement (no Movement, Minor Movement, Major Movement, Other) After EMLA Cream or Placebo Cream Administration(At the time of LP insertion)
- Complications Including Any Change in Vital Signs That Requires Intervention by the Sedation Team, Post-LP Back Pain From Sedation With or Without EMLA Cream(Within one week of the LP)