Opioid Sparing Anesthesia Care for Pediatric Patients Having Tonsil Surgery; a Randomized, Controlled, Non-inferiority Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 62
- 试验地点
- 1
- 主要终点
- Post Operative Anesthesia Unit Length of Stay (hours)
研究概览
简要总结
This is a prospective, randomized, controlled, non-inferiority study of patients undergoing tonsil surgeries at Boston Children's Hospital Waltham. The overall aim is to evaluate the efficacy of an opioid anesthetic plan (morphine, ketorolac, and acetaminophen versus an opioid sparing anesthetic plan (dexmedetomidine, ketorolac and acetaminophen) for perioperative analgesia and recovery time in patients undergoing tonsillectomies and tonsillotomies at Boston Children's Hospital Waltham. Secondary measures include rescue opioids administered in post-anesthesia care unit (PACU), re-operation secondary to bleeding, emergence delirium, post-operative nausea and vomiting, intraoperative hemodynamics, intraoperative vasopressor administration, and length of procedure.
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)
入排标准
- 年龄范围
- 3 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •American Society of Anesthesia classification status I-III
- •Ages 3 years to 17 years
- •Scheduled for tonsillectomy or tonsillotomy with or without adenoidectomy at Boston Children's Hospital Waltham
排除标准
- •Patients not scheduled for primary tonsillectomy/tonsillotomy.
- •Patients with known coagulopathies
- •Patients with previous chronic pain syndromes
- •Patients with any condition/indication that would prevent them from being able to be randomized (i.e. allergy to one of the study medications)
研究组 & 干预措施
Opioid-Sparing Anesthetic Plan
For their tonsil surgery, subjects will receive Dexmedetomidine (1mcg/kg bolus given intravenously at induction of anesthesia) and Acetaminophen (12.5mg/kg with a maximum dose of 1 gram given intravenously at induction of anesthesia). Ketorolac 0.5mg/kg with a max dose of 30mg given intravenously at the end of surgery. No opioids will be given during the procedure.
干预措施: Dexmedetomidine (Drug)
Opioid-Sparing Anesthetic Plan
For their tonsil surgery, subjects will receive Dexmedetomidine (1mcg/kg bolus given intravenously at induction of anesthesia) and Acetaminophen (12.5mg/kg with a maximum dose of 1 gram given intravenously at induction of anesthesia). Ketorolac 0.5mg/kg with a max dose of 30mg given intravenously at the end of surgery. No opioids will be given during the procedure.
干预措施: Acetaminophen (Drug)
Opioid-Sparing Anesthetic Plan
For their tonsil surgery, subjects will receive Dexmedetomidine (1mcg/kg bolus given intravenously at induction of anesthesia) and Acetaminophen (12.5mg/kg with a maximum dose of 1 gram given intravenously at induction of anesthesia). Ketorolac 0.5mg/kg with a max dose of 30mg given intravenously at the end of surgery. No opioids will be given during the procedure.
干预措施: Ketorolac (Drug)
Opioid Anesthetic Plan
For their tonsil surgery, subjects will receive Morphine (0.1mg/kg given intravenously at induction of anesthesia) and Acetaminophen (12.5mg/kg with a maximum dose of 1 gram given intravenously at induction of anesthesia). Ketorolac 0.5mg/kg with a max dose of 30mg intravenously at the end of surgery.
干预措施: Acetaminophen (Drug)
Opioid Anesthetic Plan
For their tonsil surgery, subjects will receive Morphine (0.1mg/kg given intravenously at induction of anesthesia) and Acetaminophen (12.5mg/kg with a maximum dose of 1 gram given intravenously at induction of anesthesia). Ketorolac 0.5mg/kg with a max dose of 30mg intravenously at the end of surgery.
干预措施: Ketorolac (Drug)
Opioid Anesthetic Plan
For their tonsil surgery, subjects will receive Morphine (0.1mg/kg given intravenously at induction of anesthesia) and Acetaminophen (12.5mg/kg with a maximum dose of 1 gram given intravenously at induction of anesthesia). Ketorolac 0.5mg/kg with a max dose of 30mg intravenously at the end of surgery.
干预措施: Morphine (Drug)
结局指标
主要结局
Post Operative Anesthesia Unit Length of Stay (hours)
时间窗: From entry to the Post Anesthesia Care Unit to exit from the Post-Anesthesia Care Unit. Assessed for up to 8 hours on the date of surgery
Length of time spent in the Post Operative Anesthesia Unit after tonsil surgery
Median Pain Scores in the Post-Anesthesia Care Unit
时间窗: entry to post-anesthesia care unit to 2-6 hours post-operatively
Median Pain Scores in the Post-Anesthesia Care Unit measured by the numeric rating scale (NRS), Wong-Baker Faces scale or FLACC (Face, Legs, Activity, Cry, Consolability) scale as indicated based on patient age and development. All scales are done on a 0-10 point scale with 0 being no pain and 10 being the highest pain.
Post-operative pain at 12-24 hours
时间窗: 12-24 hours post-operatively
Pain categorized as none, mild, moderate, and severe. Taken from the routine follow-up nursing phone call.
次要结局
- Intraoperative Blood pressure (mmHg)(10 minutes)
- Opioid rescue medication administration(surgery end to 2-6 hours post-operatively)
- Procedure length (minutes)(0-60 minutes)
- Intraoperative Heart rate (beats per second)(10 minutes)
- Emergence Delirium(surgery end to 2-6 hours post-operatively)
- Post-operative nausea and vomiting(surgery end to 2-6 hours post-operatively)
- Vasopressor administration(0-60 minutes)
研究者
Arielle Mizrahi-Arnaud
MD, Anesthesia, Critical Care and Pain Medicine, Principal Investigator
Boston Children's Hospital