Randomised controlled study to compare coblator and microdebrider methods for intensity of postoperative pain in Adenoidectomy
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 134
- 试验地点
- 1
- 主要终点
- To compare postoperative pain intensity by VAS in microdebrider and coblation methods for adenoidectomy
研究概览
简要总结
Institutional ethical committee clearance is obtained, consent/assent will be taken.the care givers of the patients in case of children whereas in adults the patients will be explained about the randomised controlled trial in detail, willingness is there to enter the trial they will randomly be allowed into either group A (coblation) and group B (Microdebrider) by computer generated number, allocation concealment will be done using opaque sealed envelopes. Only outcome measurer will be blinded. Preoperative clinical and laboratory evaluation will be done and patients with active infection, bleeding disorder will be excluded. Intra-operative findings like surgical time, intraoperative blood loss will be recorded by the nurse/MPW, along with Post-operative findings like postoperative pain will be recorded by the team who were not a part of the OT.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Outcome Assessor Blinded
入排标准
- 年龄范围
- 2.00 Year(s) 至 20.00 Year(s)(—)
- 性别
- All
入选标准
- •Symptomatic Adenoid hypertrophy.
排除标准
- •Presence of active infection Bleeding and clotting disorder Overt or submucous cleft palate.
结局指标
主要结局
To compare postoperative pain intensity by VAS in microdebrider and coblation methods for adenoidectomy
时间窗: To compare postoperative pain intensity by VAS in microdebrider and coblation methods for adenoidectomy | 1)6 hours after the surgery | 2)24 hours after the surgery | 3) 7 days after the surgery
次要结局
- 1.To compare intraoperative blood loss in microdebrider and coblation method for adenoidectomy(2.To compare surgical time in microdebrider and coblation method for adenoidectomy)
研究者
Somya Maskara
Bharati Hospital and research Centre
