Intravenous Lidocaine to Decrease Postoperative Pain in Pediatric Patients Undergoing Tonsillectomy: A Randomized, Double Blind, Placebo Controlled Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 89
- 试验地点
- 1
- 主要终点
- Observer Rated Pain Intensity
研究概览
简要总结
The purpose of this study is to determine whether giving lidocaine intravenously during and after a tonsillectomy surgery is effective in decreasing postoperative pain.
详细描述
The purpose of this study is to determine whether giving lidocaine intravenously during and after a tonsillectomy surgery is effective in decreasing postoperative pain when compared to placebo.
Participants will be in one of two arms. Those in Arm 1 will receive a lidocaine bolus and infusion throughout the initial recovery period while those in Arm 2 will receive an equal volume of normal saline. Subjects will be monitored and assessed for pain during their time in the hospital and followed up on at home for a week after the surgery. Primary outcomes will be measure of pain. Secondary outcome measures will include pain medication use, emergence delirium, incidence of laryngospasm, and side effects.
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)
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 for Tonsillectomy (with or without Adenoidectomy) with Dr. Kathleen Billings or Dr. Stephen Hoff at Lurie Children's Hospital
- •American Society of Anesthesiology (ASA) patient classification I-III (Healthy patient to a patient with mild systemic disease)
排除标准
- •Physical or developmental delays
- •Psychiatric illness
- •Current use of sedative or anticonvulsant medications
- •Pre-existing renal disease (ranging from stage 2 [mild] to stage 5 [end stage])
- •Pre-existing cardiovascular disease (including, not limited to congenital heart disease or arrythmia)
- •Pre-existing liver disease
- •Pre-existing cerebral or neuromuscular disease
- •Patient or family history of Malignant Hyperthermia
- •Recent history of upper respiratory infection within last 7 days
- •Regular use of analgesic medication
- •Diagnosis of severe obstructive sleep apnea requiring overnight stay for observation
- •Other procedure scheduled in addition to tonsillectomy
- •History of allergies to local anesthetics
研究组 & 干预措施
Lidocaine
Following intraoperative IV placement, a 1.5 mg/kg bolus does of lidocaine hydrochloride is given and is followed by a continuous infusion of 2 mg/kg/hr until discharge from the Phase 1 recovery period.
干预措施: Lidocaine (Drug)
Placebo
Following intraoperative IV placement, a bolus of saline is given and is followed by a continuous infusion until discharge from the Phase 1 recovery period. The volume of the bolus and rate of infusion are equivalent to that which would have been given in the experimental arm.
干预措施: Saline (Drug)
结局指标
主要结局
Observer Rated Pain Intensity
时间窗: Within the immediate post-operative period (90 minutes after surgery)
Observer Rated Pain Intensity will be measured using the Children's Eastern Ontario Pain Scale (CHEOPS) at regular 5 and 15 minute time intervals.
次要结局
- Observer Rated Emergence Delirium(Within the immediate post-operative period (90 minutes after surgery))
- Observer Rated PACU Discharge Criteria(Within the immediate post-operative period (90 minutes after surgery))
- Patient Rated Pain Intensity(Within the immediate post-operative period (90 minutes after surgery))
- Parent Rated Postoperative Pain at Home(Every day, up to 7 days postoperatively)
- Medication Journal(Every day, up to 7 days postoperatively)
研究者
Hubert Benzon
Principal Investigator
Ann & Robert H Lurie Children's Hospital of Chicago