Comparison of ropivacaine local infiltration with and without dexmedetomidine for post- operative analgesia in children undergoing tonsillectomy:a randomised controlled study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Duration of analgesia, defined as the time from completion of surgery to the first request for postoperative rescue analgesic.
研究概览
简要总结
This randomized, double-blind, controlled study aims to compare the efficacy of peritonsillar infiltration with 0.20% ropivacaine and 1 mcg/kg dexmedetomidine versus 0.20% ropivacaine alone for postoperative analgesia in children aged 4–12 years undergoing tonsillectomy. The primary objective is to compare the duration of analgesia between the two groups. Secondary objectives include comparing postoperative pain scores, total rescue analgesic consumption, intraoperative blood loss, incidence and severity of emergence delirium, parental pain assessment, and surgeon satisfaction. We hypothesize that adding dexmedetomidine to ropivacaine will prolong analgesia and improve postoperative recovery without increasing adverse effects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant, Investigator and Outcome Assessor Blinded
入排标准
- 年龄范围
- 4.00 Year(s) 至 12.00 Year(s)（—）
- 性别
- All
入选标准
- •Patient Aged 4-12 years with American Society of Anaesthesiologists physical status I-II.
排除标准
- •Children with allergy to study drugs, requiring additional surgery, having intellectual disability affecting pain assessment, or with significant cardiac/respiratory disease will be excluded.
结局指标
主要结局
Duration of analgesia, defined as the time from completion of surgery to the first request for postoperative rescue analgesic.
时间窗: From arrival in the PACU and monitored until 24 hours postoperatively
次要结局
- Postoperative Wong–Baker FACES pain scores(on PACU arrival, 30 min, 6 h, 12 h, 18 h, 24 h, and 1 week post-op.)
- Intraoperative blood loss in ml(Measured during surgery)
- Total rescue analgesic consumption(Cumulative amount over first 24 hours post op)
- Emergence delirium PAED score(At 0, 5, 10, 15 and 20 minutes after PACU interval)
- Parents postoperative pain measure - PPMP(At 24 hours and 1 week post op)
- Surgeons satisfaction score- Likert 5 point(At 24 hours post op)
研究者
Pooja
Maulana Azad Medical College,New Delhi