Comparison of preoperative peritonsillar infiltration of Ropivacaine vs Ropivacaine plus Dexmedetomidine on postoperative analgesia following tonsillectomy
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- To compare postoperative analgesia after infiltration of Ropivacaine vs Ropivacaine plus Dexmedetomidine preoperatively in anterior and posterior tonsillar pillars
研究概览
简要总结
This is a prospective randomised double blind comparative study to compare preoperative infiltration of Ropivacaine vs Ropivacaine plus dexmedetomidine on postoperative analgesia following tonsillectomy in sample size of 60 patients in the age group 5-18yrs with ASA 1 and 2 fitness.
Parameters compared are pain scores postoperatively,time of rescue analgesia, side-effects like nausea, vomiting
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded
入排标准
- 年龄范围
- 5.00 Year(s) 至 18.00 Year(s)（—）
- 性别
- All
入选标准
- •ASA grade 1 and 2 fit patients 2)Ages between 5 and 18 years f either gender 3) Patients posted for elective tonsillectomy under GA 4) Availability of informed consent.
排除标准
- •Patients with bleeding and coagulation disorders, hepatic and renal diseases, airway problems, patients with cognitive and developmental problems, patients with neurological and physiological disorders.
- •Patients with known hypersensitivity to the used local anaesthetic.
- •Patients who refused to participate in this study.
- •Signs of acute pharyngeal infection 5)Peritonsillar abscess 6)Use of regular anaesthetic medication 7) Patients below 5 years and above 18 years of age 8)ASA grade 3 and above.
结局指标
主要结局
To compare postoperative analgesia after infiltration of Ropivacaine vs Ropivacaine plus Dexmedetomidine preoperatively in anterior and posterior tonsillar pillars
时间窗: After infiltration of the drug,both groups will be compared for analgesic efficacy immediately postoperatively at 1 hr,2 hr,4 hr,8 hr,12 hr,24 hr.
次要结局
- To compare the analgesic efficacy of preoperative pillar infiltration of Dexmedetomidine in addition to Ropivacaine in tonsillectomy patients(To compare the time for first rescue analgesia, analgesic requirement in 24 hours,side effects like sedation,PONV, time of start of oral intake)
研究者
Dr Amala Kale
Dr. D.Y Patil Medical College, Hospital and Research Centre, Pimpri, Pune Research Centre