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

Remifentanil intravenous patient controlled analgesia (PCA) versus intramuscular pethidine for pain relief in labour: a randomised controlled trial - RESPITE

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2012-005257-22-GB

Enrollment

Unknown

Registered

2013-06-21

Start date

2013-07-12

Completion date

Unknown

Last updated

2017-08-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Childbirth

Interventions

Trade Name: Remifentanil Product Name: Remifentanil Product Code: N/A Pharmaceutical Form: Powder for concentrate for solution for infusion INN or Proposed INN: Remifentanil CAS Number: 132875-61-7 C

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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. To determine if remifentanil PCA is cost-effective in comparison to current practice of im pethidine. ;Primary end point(s): Primary outcome The proportion of women who receive epidural analgesia for pain relief in labour, in each group, after randomisation. ;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).	—

Measure

Time frame

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. To determine if remifentanil PCA is cost-effective in comparison to current practice of im pethidine. ;Primary end point(s): Primary outcome The proportion of women who receive epidural analgesia for pain relief in labour, in each group, after randomisation. ;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).

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Secondary

Measure	Time frame
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.	—

Measure

Time frame

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.

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Countries

United Kingdom

Contacts

Public ContactDr Victoria Brookes

University of Birmingham, Birmingham Clinical Trials Unit

v.l.brookes@bham.ac.uk01214159108

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026