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临床试验/NCT04847024
NCT04847024已完成不适用

Parecoxib vs. Dexketoprofen in Combination With Acetaminophen as Additional Analgesia in Patients With Neuraxial Morphine for the Management of Pain After Cesarean Section. A Randomized, Double Blind, Controlled Trial.

Saint Thomas Hospital, Panama1 个研究点 分布在 1 个国家目标入组 380 人开始时间: 2019年7月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
380
试验地点
1
主要终点
Pain at 12 hours

研究概览

简要总结

Although it is known that parecoxib and dexketoprofen are commonly used in successful post-operative pain relief, there are very few studies that compare these two agents in their individual applications and/or combined with neuraxial analgesia with opioids and even less in post-cesarean section pain, as well as the evaluation of the side effects and their impact on the patient's functionality. For this reason, in order to approach this answer, we sought to perform this study in patients undergoing elective or emergency cesarean section in our institution, who meet the inclusion criteria, using the Visual Analog Pain Scale at 12 hrs and 24 hrs post surgery and evaluating the aforementioned side effects, comparing in one arm of the study Parecoxib + acetaminophen vs Dexketoprofen + acetaminophen in the other arm, randomizing the patients in both groups using a double-blind configuration.

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
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

性别
Female
接受健康志愿者

入选标准

  • Pregnancy 32w or more.
  • Emergency or elective caesarean section.

排除标准

  • Allergy to Parecoxib.
  • Allergy to dexketoprofen.
  • Allergy to acetaminophen.
  • General anesthesia.

研究组 & 干预措施

Parecoxib

Experimental

Parecoxib 40 mg reconstituted in 2ml of saline solution, to pass IV as a bolus, every 12hrs + acetaminophen 1g in 100cc of saline solution to pass IV in 15 minutes, every 6hrs.

干预措施: Parecoxib (Drug)

Dexketoprofen

Experimental

Dexketoprofen 50 mg in 100 cc of saline solution, protected from sunlight, to be given IV in 15 minutes, every 8hrs + acetaminophen 1g in 100 cc of saline solution to be given IV in 15 minutes, every 6hrs.

干预措施: Dexketoprofen (Drug)

结局指标

主要结局

Pain at 12 hours

时间窗: 12 hours

Evaluation of pain using the Visual Analogue Scale (from 0 to 10, where 0 is no pain and 10 is the most terrible pain imaginable)

Pain at 24 hours

时间窗: 24 hours

Evaluation of pain using the Visual Analogue Scale (from 0 to 10, where 0 is no pain and 10 is the most terrible pain imaginable)

次要结局

  • Side effects(24 hours)

研究者

发起方
Saint Thomas Hospital, Panama
申办方类型
Other
责任方
Principal Investigator
主要研究者

Osvaldo A. Reyes T.

Coordinator of research

Saint Thomas Hospital, Panama

研究点 (1)

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