Effect of Preemptive Dexamethasone and Paracetamol on Postoperative Period Following Adeno-tosillectomy in Pediatric Age Group-: A Randomized Clinical Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Total opioid consumption at PACU
研究概览
简要总结
Tonsillectomy is one of the most common surgical operations performed on children, and it is frequently linked with an increased risk of complications such as acute discomfort when swallowing and postoperative nausea and vomiting (PONV).The most prevalent causes for postponing discharge home are poorly managed pain and PONV.
详细描述
Tonsillectomy is one of the most common surgical operations performed on children, and it is frequently linked with an increased risk of complications such as acute discomfort when swallowing and postoperative nausea and vomiting (PONV). The most prevalent causes for postponing discharge home are poorly managed pain and PONV. As a result, these occurrences should be avoided and managed utilizing a multimodal strategy Because of its low cost and adequate safety profile in the treatment of post-tonsillectomy pain, acetaminophen is presently regarded the fundamental analgesic in this situation. Furthermore, acetaminophen has been recommended for use in children, and its pharmacological safety in this age group has been shown. Dexamethasone is another medication that is used to reduce postoperative pain and PONV in various procedures.
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, Investigator)
入排标准
- 年龄范围
- 3 Years 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •children aged between 3 and 16 years.
- •All patients are ASA physical status I or II scheduled to undergo a tonsillectomy with or without adenoidectomy using sharp dissection technique.
排除标准
- •psychiatric illness.
- •cardiac disease.
- •renal or hepatic impairment.
- •allergy dexamethasone , paracetamol and opioids.
研究组 & 干预措施
group (A)
will receive intravenous paracetamol 30mg/kg (max 90 mg/kg/day).
干预措施: paracetamol (Drug)
group (B)
will receive dexamethasone 0.5mg/kg IV.
干预措施: Dexamethasone (Drug)
group(C)
will received placebo 10 ml normal saline IV.
干预措施: normal Saline (Drug)
结局指标
主要结局
Total opioid consumption at PACU
时间窗: two hours postoperatively
total amount of opioid that will be taken by the patients postoperatively.
次要结局
- objective pain score(at 0 minute , 30 minutes ,1 hour and 2 hours at PACU)
研究者
Fatma Ahmed Abdel Fatah
lecturer
Benha University