Comparison Efficiency of Oral Etoricoxib Versus Intravenous Fentanyl on Post Operative Pain in Curettage Under TIVA

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追踪信息

首次提交日期 ^ICMJE

September 28, 2018

首次发布日期e ^ICMJE

October 5, 2018

最后更新发布日期

October 5, 2018

预计研究开始日期 ^ICMJE

November 1, 2018

预计主要完成日期

November 1, 2019 (主要结果测量的最终数据收集日期)

目前主要观察指标 ^ICMJE

post operative pain[ Time Frame: at 60 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]

post operative pain[ Time Frame: at 30 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]

post operative pain[ Time Frame: 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]

原始主要观察测量 ^ICMJE

与当前相同

目前的二级观察 ^ICMJE

Adverse effect from the drugs during and post operation[ Time Frame: since subject receive drugs until 60 minutes after procedure ]
Record subject experience of the following symptoms : nausea and vomiting ,dizziness, drowsiness ,allergic reaction ,chest pain ,and gastrointestinal bleeding or gastrointestinal discomfort
Amount of intravenous Propofol used in the procedure[ Time Frame: only intraoperative time ]
Record dose of intravenous Propofol that used in TIVA
The first time pain reliever was used in post operation[ Time Frame: within 60 minutes after the procedure ]
Record the first time patient asked for post operative pain reliver or visual analog pain score > 5

描述性信息

简略标题 ^ICMJE

Comparison Efficiency of Oral Etoricoxib Versus Intravenous Fentanyl on Post Operative Pain in Curettage Under TIVA

正式标题 ^ICMJE

Efficiency of Oral Etoricoxib Versus Intravenous Fentanyl On Post Operative Pain In Curettage Under TIVA : A Randomized Controlled Trial

简要概况

Comparison of the efficiency of oral Etoricoxib versus intravenous Fentanyl on post operative Pain in curettage under TIVA: A randomized controlled trial

详细说明

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

研究类型 ^ICMJE

Interventional

研究阶段

N/A

研究设计 ^ICMJE

分配: Randomized
干预模型: Parallel Assignment
干预模型描述:
盲法: Interventional
盲法描述:
主要目的: Treatment

适用条件 ^ICMJE

干预项目 ^ICMJE

Procedure: fractional curettage
Fractional curettage under TIVA by used oral Etoricoxib120 mg at 30 minutes before fractional curettage and then added intravenous Propofol 2 mg/kg when start the procedure or Intravenous Fentanyl 1 microgram/kg and Propofol 2 mg/kg when start the procedure

研究工具

Experimental: 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
Placebo Comparator: 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

招募信息

招募状态 ^ICMJE

Not yet recruiting

预计入组 ^ICMJE

原始预计入组 ^ICMJE

与当前相同

预计研究完成日期

November 1, 2019

预计主要完成日期

November 1, 2019 (主要结果测量的最终数据收集日期)

合格标准 ^ICMJE

Inclusion Criteria: - Women who having abnormal uterine bleeding undergoing fractional curettage under TIVA Exclusion Criteria: - 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

性别

参与研究的性别:

Female

年龄

最小年龄：18 Years ，最大年龄：N/A

接受健康的志愿者

没有

可入组国家 ^ICMJE

管理信息

数据检测委员会

Yes

研究涉及美国FDA监管的产品

研究美国FDA监管的药品: No
研究涉及美国FDA监管的设备产品: No

IPD 共享声明

计划分享 IPD:

Undecided

责任方

，

研究赞助商 ^ICMJE

Rajavithi Hospital

合作者 ^ICMJE

研究员 ^ICMJE

Principal Investigator: apichaya buraputthananon Rajavithi Hospital

PRS 账户

验证日期

October 2018

^ICMJE 国际医学期刊编辑委员会和世界卫生组织 ICTRP 要求的元素

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