NCT04331210Unknown不适用
Rectal Versus Oral Diclofenac Sodium in Relieving Post Episiotomy Pain
适应症
干预措施
试验速览
- 阶段
- 不适用
- 入组人数
- 1,024
- 主要终点
- Post episiotomy pain relief
研究概览
简要总结
Current study aims to compare oral diclofenac sodium with it's rectal form for analgesia of pain after episiotomy.
详细描述
- Episiotomy is a surgical incision of the perineum and the posterior vaginal wall.
- it can be done at a 60 degree angle from the vulva towards the anus or at an angle from the posterior end of the vulva.
- usually under local anesthetic and is sutured after delivery.
- It is done during second stage of labor to enlarge the opening for the baby to pass through to avoid soft-tissue tearing which may involve the anal sphincter and rectum.
- Perineal pain after episiotomy has immediate and long-term negative effects for women and their babies. These effects can interfere with breastfeeding and the care of the infant.
- Usually women undergo episiotomy need a good analgesic to overcome pain resulting from the analgesic.
- Previous study by Faiza shafi, Shazia sayed, Naheed bano, Rizwana chaudhri, Holy family hospital, Rawalpindi, Pakistan, The study was published in journal of Rawalpindi medical college and concluded that rectal diclofenac should be further promoted , for pain relief, in women following episiotomy.
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
- Single (Participant)
入排标准
- 年龄范围
- 20 Years 至 35 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •age: 20:35 years.
- •Primigravidae as elective procedure.
- •face to pubis delivery.
- •Narrow pelvic arch.
- •Elderly primigravida.
- •old perineal scar as episiotomy or perineorrhaphy.
- •Manipulative delivery.
- •To cut short second stage cases such as pre eclampsia.
- •Premature baby.
- •Fetal distress.
排除标准
- •more than 35 years.
- •pelvic inflammatory disease.
研究组 & 干预措施
Group 1
Active Comparator
Using diclofenac sodium suppository 50 mg immediately after suturing and then every 8 hours
干预措施: Diclofenac Sodium (Drug)
Group 2
Active Comparator
Using diclofenac sodium tablets 50 mg every 8 hours after birth
干预措施: Diclofenac Sodium (Drug)
结局指标
主要结局
Post episiotomy pain relief
时间窗: First three days after delivery
The relief of pain after delivery measured by pain relief scale..Pain relief scale Title: pain intensity scale Minimum 0 means no pain Maximum 4 means severe pain
次要结局
未报告次要终点
研究者
Mohammed Hosny Ahmed
Principal investigator
Assiut University
相似试验
已完成
2 期
Therapeutic effects of rectal Diclofenac sodium and intramuscular pethedine injection in the treatment of acute renal colic: A randomized clinical trialRenal colic (duo to renal stone).Unspecified renal colicIRCT201408129936N9Shiraz University of Medical Sciences, Shiraz, Iran600
尚未招募
Unknown
Rectal versus oral diclofenac for relief of perineal pain after episiotomy repair in Enugu, Nigeria: A randomized controlled trial.PACTR202407499773220Edegware Ifeoma Shirley276
已完成
1 期
Comparative Clinical Study to Evaluate the Possible Efficacy and Safety of Oral N-Acetyl Cysteine Versus Rectal Diclofenac in the Prevention of Post Endoscopic Retrograde Cholangiopancreatography PancreatitisPost ERCP PancreatitisNCT06252441Tanta University46
已完成
4 期
A clinical trial to study the effects of two drugs, diclofenac sodium and paracetamol for pain relief following childbirth.CTRI/2017/05/008521Jawaharlal Institute of Postgraduate Medical Education and Research262
尚未招募
不适用
Rectal versus Oral Diclofenac for Relief of Perineal Pain after Episiotomy Repair: A Randomized Controlled Single-blind (Outcome Assessors) StudyPregnancy and ChildbirthPACTR202103495385214Dr. Ifeagwu Chika Sampson176