Decreasing Propofol Injection Pain by Pre-Treatment With Lidocaine in Pediatric Procedural Sedation
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 171
- 试验地点
- 1
- 主要终点
- Change in FLACC (Face, Legs, Activity, Cry, Consolability) Score
研究概览
简要总结
This is a double blind, randomized, controlled study. The sedationist performing the sedation procedure will inject the appropriate amount of either a 1% Lidocaine solution or a placebo before the administration of Propofol. A research staff will observe the patient simultaneously with the induction of Propofol to determine the patient's pain level, as measured by the Face, Legs, Activity, Cry, Consolability (FLACC) scale. The purpose of this study is to determine the efficacy of premedication with 1% Lidocaine in decreasing the burning sensation caused by intravenous Propofol.
详细描述
Propofol is a short-acting, intravenously administered anesthetic. It has become a popular choice for procedural sedation in both children and adults. Despite its many advantages, Propofol is associated with a burning sensation during injection. Propofol pain begins within the first few seconds after administration and often lasts approximately 10-20 seconds until the patient is asleep. Lidocaine is often used in an attempt to reduce Propofol injection pain, but neither its delivery mode nor concentration has been standardized.
The purpose of this study is to determine the efficacy of premedication with 1% Lidocaine in decreasing the burning sensation caused by intravenous Propofol.
This is a double blind, randomized, controlled study. The sedationist performing the sedation procedure will inject the appropriate amount of either a 1% Lidocaine solution or a placebo before the administration of Propofol. A research staff will observe the patient simultaneously with the induction of Propofol to determine the patient's pain level, as measured by the FLACC scale.
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 (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 2 Months 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age 2 months to 17 years
- •patient already scheduled for procedural sedation with propofol
- •sedation procedure to be performed by a sedationist from Children's Respiratory and Critical Care Specialists
排除标准
- •patients who are not receiving deep sedation with propofol
- •patients with allergy or other contraindication to lidocaine administration
- •patients with central venous catheters as propofol does not burn when given centrally
- •patients being premedicated with an analgesic other than nitrous oxide or 1% lidocaine
- •patients weighing less than 5 kg to prevent any risk of inadvertent lidocaine overdose.
研究组 & 干预措施
Lidocaine
Administration of 1ml of pre-treatment 1% lidocaine immediately prior to propofol induction.
干预措施: Lidocaine (Drug)
Lidocaine
Administration of 1ml of pre-treatment 1% lidocaine immediately prior to propofol induction.
干预措施: Propofol (Drug)
Normal Saline
Administration of 1ml of pre-treatment normal saline immediately prior to propofol induction.
干预措施: Normal Saline (Drug)
Normal Saline
Administration of 1ml of pre-treatment normal saline immediately prior to propofol induction.
干预措施: Propofol (Drug)
结局指标
主要结局
Change in FLACC (Face, Legs, Activity, Cry, Consolability) Score
时间窗: 1 minute before propofol induction compared to 1 minute following propofol induction
The FLACC scale measures pain in children aged 2m-7y. The scale ranges from 0-10 with 0 being no pain. The total score out of 10 is based on 5 pieces of criteria, and each criteria is scored as either 0, 1, or 2. Scores on individual criteria are summed up to give a total score. Higher values represent a worse outcome of more pain. FLACC scores will be compared pre- and post-propofol induction to assess the change in FLACC score for each arm.
次要结局
- Parental Assessment of Child's Pain on a Visual Analog Scale(Immediately following propofol injection)