A Randomised Controlled Trial of Remifentanil Intravenous Patient Controlled Analgesia (PCA) Versus Intramuscular Pethidine for Pain Relief in Labour

NCT02179294 | Completed Phase 4 DMC

• 2 other identifiers: RG_12-1512012-005257-22
• Study Type: interventional
• Target: 401
• Locations: 1 country
• Sites: 1

Brief Summary

Childbirth can be an extremely painful and the provision of pain relief during labour is a vital component of a positive maternal experience. The majority of women who deliver in modern obstetric units choose a pharmacological method of pain relief, including Entonox, the injection of opioids or epidural placement. The commonest opioid used in labour is pethidine administered by intramuscular (im) injection. The effectiveness of pain relief provided by pethidine has long been challenged. Its shortcomings are more serious when set against known side effects including maternal sedation, nausea and potential transfer across the placenta to the foetus. More than a third of women who receive pethidine subsequently require an epidural due to inadequate pain relief. Epidurals provide highly effective pain relief, but increase the risk of a forceps or suction delivery resulting in prolonged hospital stay. Therefore, there is a clear need for a safe, effective, easy to administer analgesic alternative.

Conditions

Pain Relief in Labour

Keywords

Pain relief; Labour; Child birth; Anaesthetics

Outcome Measures

Primary Outcomes (1)

• The proportion of women who receive epidural analgesia for pain relief in labour, in each group, after randomisation.

  The proportion of women who receive epidural analgesia for pain relief in labour, in each group, after randomization.

  At labour

Secondary Outcomes (10)

• • The effectiveness of pain relief provided by each technique, quantified by Visual Analogue Scale

  Post natally - Average of 2-3days after delivery

• The incidence of maternal side effects

  Post Natally - Average of 2-3days after delivery

• Delivery mode (Spontaneous, Instrumental Vaginal, Caesarean Section)

  Post Natally - Average of 2-3days after delivery

• Incidence of foetal distress requiring delivery

  Post Natally - Average of 2-3days after delivery

• Neonatal status at delivery

  Post Natally - Average of 2-3days after delivery

Study Arms (2)

Pethidine

ACTIVE COMPARATOR

Pethidine is pain relief in labour

Drug: Pethidine

Remifentanil

ACTIVE COMPARATOR

Remifentanil intravenous patient controlled analgesia

Drug: Remifentanil

Interventions

Pethidine DRUG

100mg by intramuscular injection, up to 4 hourly in frequency (up to a maximum of 4 doses). The maximum dose being 400mg in 24 hours.

Also known as: Meperidine

Pethidine

Remifentanil DRUG

Dedicated intravenous cannula for remifentanil administration PCA protocol * PCA bolus remifentanil 40 μg * Lockout interval 2 minutes In the event of excess sedation being recorded by regular observation of respiratory function, the regimen will be altered by reduction of the remifentanil bolus dose to 30 μg with a lock-out interval of 2 minutes.

Also known as: Ultiva

Remifentanil

Eligibility Criteria

• Age: 16 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Women who are admitted to labour ward who fulfil all the following criteria will be eligible to be randomised:
• Requesting systemic opioid analgesia
• years of age or older
• Beyond 37 weeks gestation
• In established labour, defined as regular painful contractions, irrespective of cervical dilatation, with vaginal birth intended
• Able to understand all information (written and oral) presented (using an interpreter if necessary)
• Not participating in any other clinical trial of a medicinal product
• Live, singleton pregnancy with cephalic presentation

You may not qualify if:

• Contraindication to epidural analgesia
• Contraindication to intramuscular injection
• History of a previous adverse reaction to pethidine or remifentanil
• Patients taking long term opioid therapy including Methadone
• Systemic pain relief opioid in the 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).

Sponsors & Collaborators

• University of Birmingham: lead
• Heartlands Hospital: collaborator
• Good Hope Hospital: collaborator
• Birmingham Women's NHS Foundation Trust: collaborator
• York Hospital: collaborator
• University Hospital of North Midlands: collaborator
• Frimley Park Hospital: collaborator
• Bradford Royal Infirmary: collaborator
• Stoke Mandeville Hospital: collaborator
• Clinical Research and Trials Unit (Norfolk & Norwich University Hospital, UK): collaborator
• Medway Maritime Hospital: collaborator
• Northwick Park Hospital: collaborator
• Homerton University Hospital: collaborator
• City Hospital Birmingham: collaborator
• Warwick Hospital: collaborator
• University Hospital Coventry: collaborator

Study Sites (1)

Birmingham Clinical Trials Unit

Birmingham, West Midlands, B15 2TT, United Kingdom

Location

Related Links

• Trial website

MeSH Terms

Interventions

Meperidine; Remifentanil

Intervention Hierarchy (Ancestors)

Isonipecotic Acids; Acids, Heterocyclic; Heterocyclic Compounds; Piperidines; Heterocyclic Compounds, 1-Ring; Propionates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals

Study Officials

• Matthew JA Wilson

  Sheffield Teaching Hospitals NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 11, 2014
• First Posted: July 1, 2014
• Study Start: May 1, 2014
• Primary Completion: September 1, 2016
• Study Completion: September 1, 2016
• Last Updated: October 15, 2018

Record last verified: 2018-10

Locations

GB (1)