Oral Tramadol Versus Oral Celecoxib for Post-perineal Repair Analgesia
赞助:
Cairo University
合作者:
信息的提供 (责任方):
Ahmed Samy aly ashour，Cairo University
| 追踪信息 | |||
|---|---|---|---|
| 首次提交日期 ICMJE | October 2, 2018 | ||
| 首次发布日期e ICMJE | October 3, 2018 | ||
| 最后更新发布日期 | October 3, 2018 | ||
| 预计研究开始日期 ICMJE | October 10, 2018 | ||
| 预计主要完成日期 | December 5, 2018 (主要结果测量的最终数据收集日期) | ||
| 目前主要观察指标 ICMJE |
perineal pain[ Time Frame: 1 hour after repair of episiotomy ] perineal pain severity using visual analogue scale |
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| 原始主要观察测量 ICMJE | 与当前相同 | ||
| 目前的二级观察 ICMJE |
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| 描述性信息 | |||
| 简略标题 ICMJE | Oral Tramadol Versus Oral Celecoxib for Post-perineal Repair Analgesia | ||
| 正式标题 ICMJE | Oral Tramadol Versus Oral Celecoxib for Post-perineal Repair Analgesia After Spontaneous Vaginal Birth in Obese Women: A Randomised Controlled Trial | ||
| 简要概况 | This trial will be performed to compare the effectiveness of oral tramadol versus oral celecoxib for the management of perineal pain following episiotomy or perineal tear repair after spontaneous vaginal birth in obese women |
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| 详细说明 | Pain after episiotomy or tear of perineal tissues during childbirth is often inadequately treated and may be severe. Not only did perineal pain negatively affect the physical and mental functioning of the woman, but also it might decrease the success of breastfeeding and reduced her ability to care for her child. The methods of relieving perineal pain included medication and non-medication. When the perineal pain was mild, the most common analgesic used was acetaminophen. Whereas the perineal pain was more severe, other drugs had been chosen such as opioid, non-opioid, and a combination of both opioid and non-opioid analgesics | ||
| 研究类型 ICMJE | Interventional | ||
| 研究阶段 | Phase 4 | ||
| 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 |
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| 适用条件 ICMJE | |||
| 干预项目 ICMJE |
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| 研究工具 |
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| 招募信息 | |||
| 招募状态 ICMJE | Not yet recruiting | ||
| 预计入组 ICMJE |
200 | ||
| 原始预计入组 ICMJE | 与当前相同 | ||
| 预计研究完成日期 | December 10, 2018 | ||
| 预计主要完成日期 | December 5, 2018 (主要结果测量的最终数据收集日期) | ||
| 合格标准 ICMJE | Inclusion Criteria: - Age:18-35 years - Obese women with BMI ≥ 30. - completed full 37-weeks gestation. - spontaneous vaginal delivery with medio-lateral episiotomy or perineal tear requiring repair. - Singleton alive fetus. Exclusion Criteria: - known allergy to investigated drugs(tramadol or celecoxib). - regular use of analgesic drugs before or during pregnancy. - any medical condition known to be potentially exacerbated by opioids, including alimentary canal disorders, hepatic and renal disease. - instrumental vaginal delivery. - 3rd or 4th degree perineal tear. - severe postpartum haemorrhage (>1,500 ml). - complicating maternal diseases (pregestational/gestational diabetes mellitus; bleeding disorders; pre-eclampsia and other hypertensive disorders of pregnancy). - epidural nor combined spinal-epidural analgesia in labour - a history of peptic ulcer,asthma,thrombocytopaenia. | ||
| 性别 |
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| 年龄 | 最小年龄：18 Years ，最大年龄：35 Years | ||
| 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 | ||
| 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 |
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| IPD 共享声明 |
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| 责任方 | Ahmed Samy aly ashour，Cairo University | ||
| 研究赞助商 ICMJE | Cairo University | ||
| 合作者 ICMJE | |||
| 研究员 ICMJE |
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| PRS 账户 | Cairo University | ||
| 验证日期 | October 2018 | ||
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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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