ISRCTN29654603
Completed
Phase 4
Remifentanil intravenous patient controlled analgesia (PCA) versus intramuscular pethidine for pain relief in labour: a randomised controlled trial
niversity of Birmingham (UK)0 sites400 target enrollmentAugust 8, 2013
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Topic: Reproductive Health and Childbirth
- Sponsor
- niversity of Birmingham (UK)
- Enrollment
- 400
- Status
- Completed
- Last Updated
- 5 years ago
Overview
Brief Summary
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)
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Not specified
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