ISRCTN29654603已完成4 期
Remifentanil intravenous patient controlled analgesia (PCA) versus intramuscular pethidine for pain relief in labour: a randomised controlled trial
niversity of Birmingham (UK)0 个研究点目标入组 400 人开始时间: 2013年8月8日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 400
研究概览
简要总结
2016 protocol in https://www.ncbi.nlm.nih.gov/pubmed/27955688 2018 results in https://www.ncbi.nlm.nih.gov/pubmed/30115484 2019 qualitative sub-study results in https://pubmed.ncbi.nlm.nih.gov/31874879/ (added 05/11/2020)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- Female
入选标准
- •Current inclusion criteria as of 23/04/2015:
- •1. Requesting systemic opioid analgesia
- •2. 16 years of age or older
- •3. Beyond 37+0 weeks' gestation
- •4. In established labour (defined as regular painful contractions, irrespective of cervical dilatation) with vaginal birth intended
- •5. Able to understand all information (written and oral) presented (using an interpreter if necessary) and provide signed consent
- •6. Not participating in any other clinical trial of a medicinal product
- •7. Live, singleton pregnancy with cephalic presentation
- •Previous inclusion criteria:
- •1. Requesting systemic opioid analgesia
- •2. 16 years of age or older
- •3. Beyond 30+0 weeks' gestation
- •4. In established labour with vaginal birth intended
- •5. Able to understand all information (written and oral) presented (using an interpreter if necessary) and provide signed consent
- •6. Not participating in any other clinical trial of a medicinal product
- •7. Singleton pregnancy with cephalic presentation
排除标准
- •Exclusion criteria as of 21/12/2015:
- •1. Contraindication to epidural analgesia
- •2. Contraindication to intramuscular injection
- •3. History of a previous adverse reaction to pethidine or remifentanil
- •4. Patients taking any long-term opioid drug therapy including Methadone
- •5. Systemic opioid pain relief in last 4 hours administered by intravenous or intramuscular injection. (Oral medications comprising opioids alone or in combination preparations, administered in this 4 hour period, are permitted).
- •Previous exclusion criteria as of 23/04/2015:
- •1. Contraindication to epidural analgesia
- •2. Contraindication to intramuscular injection
- •3. History of drug sensitivity to pethidine or remifentanil
- •4. Patients taking any long-term opioid drug therapy including Methadone
- •5. Systemic opioid pain relief in last 4 hours
- •Previous exclusion criteria:
- •1. Contraindication to epidural analgesia
- •2. Contraindication to intramuscular injection
- •3. History of drug sensitivity to pethidine or remifentanil
- •4. Patients taking any long-term opioid drug therapy including Methadone
研究者
相似试验
招募中
不适用
Comparing patient satisfaction and costs between epidural and remifentanil during labour in low risk pregnant women.Vergelijking van tevredenheid en kosten tussen epidurale anesthesie met remifentanil bij laag risico zwangeren.This study will assess in women with a request for pain relief during labor the costeffectivenessof RPCA as first choice treatment compared to EA.Epidurale anesthesie meest effectieve vorm van pijnbestrijding. Echter de tevredenheid van de patient tav epidurale anesthesie vergeleken met remifentanil, in dit geval laag risico zwangere, is niet bekend.NL-OMON20738AMC408
已完成
不适用
RAVEL Trial; Remifentanil patient-controlled analgesia (RPCA) vs epidural analgesia (EA) during labourPain during labour10010273NL-OMON38234eids Universitair Medisch Centrum1,136
进行中（未招募）
1 期
Remifentanil intravenous patient controlled analgesia (PCA) versus Intramuscular Pethidine for pain relief in labour.ChildbirthEUCTR2012-005257-22-GBniversity of Birmingham
尚未招募
不适用
Remifentanil patient gecontroleerde pijnstilling versus epidurale pijnstilling tijdens de bevalling.remifentanil, PCA, epidural, analgesia, labourNL-OMON28699MC1,136
已完成
不适用
Efficacy and Satisfaction With Remifentanil Analgesia in Parturients During the ChildbirthComplication of Labor and/or DeliveryNCT02447757Brno University Hospital66