Efficiency of Oral Etoricoxib Versus Intravenous Fentanyl on Post Operative Pain in Curettage Under TIVA : a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- post operative pain
研究概览
简要总结
Comparison of the efficiency of oral Etoricoxib versus intravenous Fentanyl on post operative Pain in curettage under TIVA: A randomized controlled trial
详细描述
Fractional Curettage is the most widely used for diagnostic and treatment abnormal uterine bleeding. The patient categorize post-operative pain as mild to moderate. Therefore, the effective analgesic added on intraoperative and post-operative is the most important factor in patient's satisfaction, patient well co-operation, shortness time of operation, decrease unpleasant symptoms and rapid recovery. However, there are many anesthetic technique that can be used to relive pain in the operation such as local anesthesia, total intravenous anesthesia, regional anesthesia or oral analgesic drugs.
Intravenous Fentanyl is an short acting opioid. It has a fast onset of action within 2 minutes and short duration of action 30-60 minutes. Respiratory depression, hypotension and bradycardia are adverse effects that might delayed discharge especially in one day surgery e.g. fractional curettage. Etoricoxib is an oral COX-2 specific inhibitor which can be used to relieve the pain. The onset of analgesia can be occurred within 24 minutes which peak plasma level within 60 minutes. There are many empirical evidences to support the results of post-operative pain after used oral Etoricoxib or intravenous Fentanyl. However, there are less evidences to support efficiency of oral Etoricoxib versus intravenous Fentanyl on post-operative Pain in fractional curettage under TIVA
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, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women who having abnormal uterine bleeding undergoing fractional curettage under TIVA
排除标准
- •Women who have opioid or NSAIDs allergy
- •Women who disagree to participate in this study
- •Women who have history of gastrointestinal bleeding or ulcer
- •Women who have abnormal kidney function
- •Women who can't understand Thai language
- •Women who have American Society of Anesthesiologists [ASA] above 2
- •Women who have been used NSAIDs in 48 hours or often used NSAIDs
研究组 & 干预措施
Oral Etoricoxib group
Subjects will receive oral Etoricoxib120 mg 30 minutes before fractional curettage then added intravenous Propofol 2 mg/kg when start the procedure
干预措施: fractional curettage (Procedure)
Intravenous Fentanyl group
Subjects will receive oral placebo [folic acid] 1 tab 30 minutes before the procedure then added intravenous Propofol 2 mg/kg and Intravenous Fentanyl 1 microgram/kg when start the procedure
干预措施: fractional curettage (Procedure)
结局指标
主要结局
post operative pain
时间窗: at 15 minute after operation
Compare efficacy of oral Etoricoxib and intravenous Fentanyl for post fractional curettage pain by using a visual analog pain scale \[Score 0-10\]
次要结局
- The first time pain reliever was used in post operation(within 60 minutes after the procedure)
- Adverse effect from the drugs during and post operation(since subject receive drugs until 60 minutes after procedure)
- Amount of intravenous Propofol used in the procedure(only intraoperative time)