Lidocaine Infusions for Children Undergoing Combined Tonsillectomy and Adenoidectomy: A Double-Blinded, Randomized, Placebo-Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Change in Pain Scores
研究概览
简要总结
Lidocaine is widely available and is a very commonly used local anesthetic. When administered intravenously, lidocaine infusions have anti-inflammatory effects and have significantly decreased the reliance on opioid use for adequate pain management in adult abdominal and spine surgeries. A major advantage of lidocaine infusion is that it is not associated with a significant side effect profile.The role of lidocaine in pediatric acute perioperative pain remains limited.
详细描述
The aim of the study is to determine if using lidocaine continuously during anesthesia care will decrease post-operative pain for children having their tonsils and adenoids removed.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Anesthesia care providers will be acquiring the study solution from the institution's pharmacy (lidocaine or saline) to administer perioperatively. The pharmacy will prepare the study solutions per randomization and label the solution as the study solution without reference to lidocaine or saline. Per protocol, the care providers will then administer the study solution as a weight based infusion.
入排标准
- 年龄范围
- 4 Years 至 10 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •scheduled tonsillectomy and adenoidectomy with or without myringotomy/PE tubes at Hasbro Children's Hospital
排除标准
- •history of allergies to local anesthetics
- •physical or developmental delays
- •psychiatric illness
- •current use of sedative or anticonvulsive medications
- •use of premedication (oral/nasal)
- •pre-existing cardiovascular, renal, or hepatic disease
- •pre-existing cerebral or neuromuscular disease
- •patient with personal or family history of malignant hyperthermia
- •recent history of upper respiratory infection within last 7 days
- •regular use of analgesic medications
研究组 & 干预措施
Lidocaine
Lidocaine infusion at 2 mg/kg/hr will be started in the operating room and continue in the recovery period for 60 minutes.
干预措施: Lidocaine Iv (Drug)
Saline
Saline infusion at 2 mg/kg/hr will be started in the operating room and continue in the recovery period for 60 minutes.
干预措施: Saline Solution (Drug)
结局指标
主要结局
Change in Pain Scores
时间窗: 15 minute intervals in postanesthesia care unit; up to 120 minutes following surgery.
FLACC scale includes 5 categories (Face, Legs, Activity, Cry, Consolability) of pain behaviors scored from 0-2 to provide a total pain score ranging from 0 to 10 with higher numbers indicating greater or worse pain.
次要结局
- Emergence delirium scores(5 minute intervals for the first 30 minutes in postanesthesia care unit, then every 15 minutes for an additional 90 minutes after surgery)
- Parental satisfaction with the anesthetic(Evaluated once on postoperative day 1 (or 24 hours after surgery))
- Opioid consumption(Total perioperative period: time in the operating room until time of discharge to home from the postoperative anesthesia care unit (PACU))
研究者
Edward Suh MD
Principal Investigator; Clinical Instructor
Rhode Island Hospital