Oral Tramadol Versus Oral Celecoxib for Post-perineal Repair Analgesia After Spontaneous Vaginal Birth in Obese Women: A Randomised Controlled Trial
试验速览
- 阶段
- 4 期
- 入组人数
- 200
- 主要终点
- perineal pain
研究概览
简要总结
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
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Age:18-35 years
- •Obese women with BMI ≥
- •completed full 37-weeks gestation.
- •spontaneous vaginal delivery with medio-lateral episiotomy or perineal tear requiring repair.
- •Singleton alive fetus.
排除标准
- •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.
研究组 & 干预措施
tramadol
one tablet of Tramadol 100 mg (Tramaw, Global Napi, Giza,Egypt) administered orally immediately, 12 h and 24 h after randomization.
干预措施: Tramadol Hydrochloride (Drug)
celecoxib
one tablet of Celecoxib 200 mg (Celebrex® 200, Pfizer,USA) administered orally immediately, 12 h and 24 h after randomization.
干预措施: Celecoxib 200mg (Drug)
结局指标
主要结局
perineal pain
时间窗: 1 hour after repair of episiotomy
perineal pain severity using visual analogue scale
次要结局
- perineal pain(1 hours after repair of episiotomy)
研究者
Ahmed Samy aly ashour
lecturer in obstetrics and gynecology
Cairo University