Efficacy of Intravenous Lidocaine at Alleviating Pain Associated With Propofol Infusion in Pediatric Patients Undergoing Procedural Sedation
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 109
- 试验地点
- 1
- 主要终点
- Maximal Pain/Discomfort
研究概览
简要总结
This protocol describes a double-blind, placebo-controlled trial intended to demonstrate the effectiveness of lidocaine at reducing pain associated wiht propofol infusion for short-term deep sedation in children. Patients will be randomized to receive either placebo (saline) or one of two dosing regimens of IV lidocaine prior to initiating propofol infusion. The efficacy of the differing lidocaine doses will be compared to determine the minimum dose required to safely achieve alleviation of pain. We hypothesize that premedicating with lidocaine will significantly decrease pain experienced by pediatric patients receiving propofol for outpatient sedation.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 2 Years 至 7 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •scheduled for painless diagnostic procedures
- •are ASA I or ASA II
排除标准
- •have an indwelling central venous catheter
- •have received an analgesic or sedative medication in the previous four hours prior to enrollment
- •have an underlying chronic disorder that would impact on their ability to express distress when in painful or otherwise anxiety-provoking situations
- •known hypersensitivity to lidocaine or any component of the formulation
- •hypersensitivity to another local anesthetic of the amide type
- •Adam-Stokes syndrome
- •severe degrees of SA, AV, or intraventricular heart block
- •allergy to corn-related products
- •contraindication to propofol
研究组 & 干预措施
Group A
Saline
干预措施: normal saline (Drug)
Group B
Lidocaine 0.25 mg/kg
干预措施: lidocaine (Drug)
Group C
Lidocaine 0.5 mg/kg
干预措施: lidocaine (Drug)
结局指标
主要结局
Maximal Pain/Discomfort
时间窗: during initial 3 minute propofol infusion
FLACC (Face, Legs, Activity, Cry, Consolability) Pain assessment scale was administered by a trained observer. The patient's parent documented maximum distress using a 100-mm visual analog scale where "0" represented "no pain" and 100 (the furthest point to the left) represented the worst pain ever.
次要结局
未报告次要终点
研究者
Michael D. Reed
Pharm.D.
Akron Children's Hospital