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.
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
- 是
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
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
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
Osvaldo A. Reyes T.
Coordinator of research
Saint Thomas Hospital, Panama
