ACTRN12616000016437终止4 期
Pregabalin for the management of post-dural puncture headache after unintentional dural puncture in obstetric patients: a randomised, double-blind, placebo-controlled trial
King Edward Memorial Hospital for Women0 个研究点目标入组 300 人开始时间: 2016年1月13日最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- 入组人数
- 300
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Prevention
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 o limit（—）
- 性别
- Female
入选标准
- •1.Obstetric women aged 18 years and over
- •2.An unintentional dural puncture at the time of epidural analgesia for labour and delivery, confirmed by observation of efflux of cerebrospinal fluid from the needle or catheter; by identification of CSF from an epidural catheter; or by positive test-dosing for subarachnoid placement.
排除标准
- •1.Attempted postpartum prevention of PDPH using any therapy other than intrathecal epidural catheter placement, including prophylactic epidural blood patch.
- •2.Onset of PDPH prior to study drug administration
- •3.Renal impairment
- •4.Contraindication to use or exposure to pregabalin within past 72 hours
- •5.ASA 4 status
- •6.Women planning to breastfeed a premature baby
- •7.Concurrent administration of drugs that may possibly impact on the severity of PDPH, namely oral tablets of or intravenous caffeine, triptans, hydrocortisone, oral theophylline or intravenous aminophylline, epidural morphine.
研究者
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