Remifentanil intravenous patient controlled analgesia (PCA) versus Intramuscular Pethidine for pain relief in labour.

Phase 1

Conditions: Childbirth
Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

Registration Number: EUCTR2012-005257-22-GB

Lead Sponsor: niversity of Birmingham

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: Female

Target Recruitment: Not specified

Inclusion Criteria

•Requesting systemic opioid analgesia
•16 years of age or older
•Beyond 30+0 weeks’ gestation
•In established labour with vaginal birth intended
•Able to understand all information (written and oral) presented (using an interpreter if necessary) and provide signed consent.
•Not participating in any other clinical trial of a medicinal product
•Singleton pregnancy with cephalic presentation.

Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range 400
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0

Exclusion Criteria

•Contraindication to epidural analgesia
•Contraindication to intramuscular injection
•History of drug sensitivity to pethidine or remifentanil

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To conduct a RCT to determine if remifentanil PCA administered for pain relief in labour, reduces the proportion of women who subsequently require an epidural for pain relief in comparison to intermittent intramuscular pethidine (current practice).;Secondary Objective: To determine the effect of remifentanil PCA on secondary outcomes including effectiveness of pain relief, maternal sedation and oxygen requirement, duration of labour, neonatal status and resuscitation requirement, maternal satisfaction with her birth experience and successful initiation of breast feeding.<br><br>To determine if remifentanil PCA is cost-effective in comparison to current practice of im pethidine.<br>;Primary end point(s): Primary outcome<br>The proportion of women who receive epidural analgesia for pain relief in labour, in each group, after randomisation.<br>;Timepoint(s) of evaluation of this end point: The evaluation of this end point will occur at the end of labour (delivery of the infant).

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Effectiveness of pain relief, maternal sedation and oxygen requirement, duration of labour, neonatal status and resuscitation requirement, maternal satisfaction with her birth experience and successful initiation of breast feeding. Incidence of side effects including nausea & vomitting and pruritis. Delivery mode.;Timepoint(s) of evaluation of this end point: Intra-partum secondary outcomes will be evaluated contemporaneously during labour. Neonatal status will be evaluated after delivery. maternal satisfaction and breast feeding outcomes will be recorded in the post-natal period, prior to hospital discharge.