A Pilot Study: a Non-opioid Technique for Postoperative Adenoidectomy Pain Relief in Pediatric Patients
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Average Pain Score
研究概览
简要总结
This proposed study will assess analgesic efficacy of a multi-modal, non-opioid analgesic regimen for providing surgical analgesia in pediatric patients undergoing adenoidectomy and to assess recovery characteristics in the post-anesthesia care unit (PACU) and at home following surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 4 Years 至 8 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients undergoing adenoidectomy ± bilateral ear tube placement
- •Have a parent/guardian who are compliant with routine medical care, capable of subjective evaluation and able to read, understand and sign the informed consent in accordance with IRB regulations
排除标准
- •An American Society of Anesthesiologists Physical Status ≥ 4 (severe disease that is life threatening);
- •A known hypersensitivity or allergy to any of the study medications;
- •A history of chronic opioid use prior to surgery;
- •Coexisting renal or hepatic disease;
- •Morbid obesity (BMI% ≥ 99).
研究组 & 干预措施
Non-opiod pain relief
Subjects will receive preoperative oral dextromethorphan & acetaminophen and intraoperative intravenous dexmedetomidine & ketamine.
干预措施: Dextromethorphan (Drug)
Non-opiod pain relief
Subjects will receive preoperative oral dextromethorphan & acetaminophen and intraoperative intravenous dexmedetomidine & ketamine.
干预措施: Acetaminophen (Drug)
Non-opiod pain relief
Subjects will receive preoperative oral dextromethorphan & acetaminophen and intraoperative intravenous dexmedetomidine & ketamine.
干预措施: Dexmedetomidine (Drug)
Non-opiod pain relief
Subjects will receive preoperative oral dextromethorphan & acetaminophen and intraoperative intravenous dexmedetomidine & ketamine.
干预措施: Ketamine (Drug)
结局指标
主要结局
Average Pain Score
时间窗: 1 hr post-op
Visual Analogue Scale (VAS) pain scores (0 being no pain and 10 being worst pain) in post-anesthesia care unit (PACU).
次要结局
- Time in PACU(1-2 hr post-op)
- Extubation Time(1 hr post-op)
- End of Surgery to Hospital Discharge(2-3 hours post-op)
- Number of Participants With Sedation, Nausea/Vomiting, or Hallucinations(2 hours post-op)
研究者
Arlyne Thung
Attending Anesthesiologist
Nationwide Children's Hospital