Effect of Clonidine on High Volume-Low Concentration Caudals
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 129
- 试验地点
- 1
- 主要终点
- Administration of Rescue Pain Medications
研究概览
简要总结
The primary objective is to evaluate the effect of clonidine on the duration of analgesia provided by a high volume-low concentration caudal block for pediatric aurgical procedres. In addition, caudal clonidine's effect on length of recovery and post-operative emergence agitation will be measured.
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
- Double (Participant, Outcomes Assessor)
盲法说明
Outcome assessor and patient blinded to the medications in the block that the patient receives.
入排标准
- 年龄范围
- 0 Years 至 3 Years（Child）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •3 years old or less
- •Weight <= 13.3kg
- •American Society of Anesthesiology Physical Status (ASA) 1 or 2
- •Undergoing circumcision surgery
- •Patients whose plan of care includes caudal block
排除标准
- •Known allergy to clonidine, epinephrine, or amide local anesthetics
- •Inability or unwillingness of parent or legal guardian to give informed consent
研究组 & 干预措施
High Volume-Low Concentration without Clonidine
The control for this study will be a High Volume-Low Concentration (1.5cc/kg of 0.15% ropivacaine and 5mcg/cc epinephrine).
干预措施: High Volume-Low Concentration without Clonidine (Drug)
High Volume-Low Concentration with clonidine
The study intervention will be High Volume-Low Concentration with clonidine (1.5cc/kg of 0.15% ropivacaine, with 1mcg/cc of clonidine and 5mcg/cc epinephrine).
干预措施: High Volume-Low Concentration with clonidine (Drug)
结局指标
主要结局
Administration of Rescue Pain Medications
时间窗: 24 hours
Data will be collected and analyzed on the need for rescue pain medications by collecting doses of opioids administered the Post Anesthesia Care Unit.
Presence of Pain
时间窗: 24 hours
The effect of clonidine on the duration of the analgesia provided by a high volume-low concentration caudal will be measured in the Post Anesthesia Care Unit pain assessments using CHEOPS score every at 0, 30, 60, and 90 minutes after arrival to PACU. The CHEOPS pain score tool is an observational scale for measuring postoperative pain in children aged 1-7 yrs. The tool includes six categories of pain behavior, each with 3-4 levels and scores range from 4 points (no pain) to 13 points (the worst pain).
Time to first Administration of Acetaminophen
时间窗: 24 hours
24 hours after discharge a phone call interview will be conducted to obtain the time of the first dose of acetaminophen
次要结局
- Hemodynamic Changes(24 hours)
- Sedation Levels(24 hours)
- Incidence of Emergence Delirium(24 hours)
- Average Time to Discharge(24 hours)
研究者
Christopher Heine, MD
Assistant Professor
Medical University of South Carolina