跳至主要内容
临床试验/NCT06494839
NCT06494839已完成不适用

Outcomes of Bipolar Electrocautery Tonsillectomy Versus Cold Steel Dissection Pediatric Tonsillectomy

RESnTEC, Institute of Research2 个研究点 分布在 1 个国家目标入组 110 人开始时间: 2023年11月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
110
试验地点
2
主要终点
Postoperative pain

研究概览

简要总结

It was intended to practically establish whether or not the relatively newer technique of tonsillectomy like bipolar electrocautery tonsillectomy has any added benefits in reducing the duration of surgery, blood loss and post-operative pain as compared with conventional cold steel dissection method. This study was done to compare the outcomes of bipolar electrocautery tonsillectomy versus cold steel dissection pediatric tonsillectomy.

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
None

入排标准

年龄范围
5 Years 至 13 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Patients of 5-13 years of age
  • Both genders
  • With a history of recurrent episodes of tonsillitis in the last year
  • Children who had bilaterally enlarged tonsils
  • No history of fever or sore throat in the last 4 weeks

排除标准

  • Patients who had enlarged adenoids and required adenotonsillectomy
  • Patients who underwent tonsillectomy after quinsy
  • With a history of bleeding disorders
  • Patients who showed an international normalized ratio (INR) ≥ 1.5

结局指标

主要结局

Postoperative pain

时间窗: 24 hours

Postoperative pain was measured at regular intervals (6-hourly till 24 hours) using the Wong-Baker faces pain rating scale.12 The Wong-Baker faces pain rating scale graded pain as mild (1-3), moderate (4-6), or severe (\>6).

Blood loss

时间窗: up to 24 hours

Intraoperative blood loss was measured by reading the levels given in the suction bottle at the end of surgery. The weight of dry gauze was subtracted from the wet, considering 1g=1ml.

Operative time

时间窗: 1 hour

Operative time was measured from the anterior pillar incision to the removal of the mouth gag.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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