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

• Status: Completed
• Trial end date: 2016-09-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Dr Matthew Joseph Anthony Wilson; University of Birmingham
• Collaborators: Birmingham Women's NHS Foundation Trust; Bradford Royal Infirmary; City Hospital Birmingham; Clinical Research and Trials Unit (Norfolk & Norwich University Hospital, UK); Frimley Park Hospital; Good Hope Hospital; Heartlands Hospital; Homerton University Hospital; Medway Maritime Hospital; Northwick Park Hospital; Stoke Mandeville Hospital; University Hospital Coventry; University Hospital of North Midlands; University of Birmingham; Warwick Hospital; York Hospital
• Treatments: Meperidine; Remifentanil

Criteria

Inclusion Criteria:

Women who are admitted to labour ward who fulfil all the following criteria will be eligible to be randomised:

• Requesting systemic opioid analgesia

• 16 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

Exclusion Criteria:

• 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).