Comparative Study Between the Effect of Diclofanic and Ketorolac in Post Tonsillectomy Pain Management
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- pain relieve
研究概览
简要总结
Compare between the analgesic efficacy of diclofenac sodium and ketorolac tromethamine in post-tonsillectomy pain management.and Compare between the effect of diclofenac sodium and ketorolac tromethamine on post-tonsillectomy bleeding
详细描述
patients will be randomly allocated to two groups of 50 patients each Group (A): will receive intra-operative diclofenac sodium at dose of 0.3 mg/kg intravenously.
Group (B): will receive intra-operative ketorolac tromethamine at dose of 0.5 mg/kg intravenously.
Then the two groups will continue postoperatively on the same drug received intra-operative
I. Intra-operative data:
Bleeding score will be assessed by the surgeon at the end of the operation using the following Scale for bleeding assessment (0 = no bleeding, 1 = bleeding as usual, 2 = bleeding more than usual, 3 = profuse, 4 = excessive, and lastly 5 = excessive and continuous).
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
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 6 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children scheduled for elective tonsillectomy\adenotnsillectomy for chronic or recurrent tonsillitis and aged between 6 to 12 years
排除标准
- •Known hypersensitivity to medication drugs.
- •Coagulation disorders, thrombocytopenia or active bleeding for any cause.
- •Bronchial asthma.
- •Significant cardiac, renal, pulmonary, hepatic disease or peptic ulcer.
- •The use of any analgesic medications within 24h preoperative or antiplatelet medication within the past 2 weeks.
研究组 & 干预措施
diclofenac
patients will receive intra-operative diclofenac sodium at dose of 0.3 mg/kg intravenously then will continue postoperatively on the same drug received intra-operative.
干预措施: diclofenac (Drug)
ketorolac
patients will receive intra-operative ketorolac tromethamine at dose of 0.5 mg/kg intravenously then will continue postoperatively on the same drug received intra-operative.
干预措施: ketorolac (Drug)
结局指标
主要结局
pain relieve
时间窗: 24 hours
the verbal rating scale (VRS; 0 = no pain, 1 = mild pain, 2 = moderate pain, 3= severe pain, and lastly 4= excruciating pain). VRS assessment will be performed immediately postoperative and 3, 6, 12 and 24h postoperatively
次要结局
- dysphagia(two weeks)
- bleeding(two weeks)
研究者
Hala Saad Abdel-Ghaffar
assistant professor
Assiut University