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

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

Interventions

DRUG

Pethidine

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.

DRUG

Remifentanil

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.

Sponsors & Collaborators

• Heartlands Hospital

  collaborator UNKNOWN

• Good Hope Hospital

  collaborator UNKNOWN

• Birmingham Women's NHS Foundation Trust

  collaborator OTHER_GOV

• York Hospital

  collaborator UNKNOWN

• University Hospital of North Midlands

  collaborator UNKNOWN

• Frimley Park Hospital

  collaborator UNKNOWN

• Bradford Royal Infirmary

  collaborator OTHER

• Stoke Mandeville Hospital

  collaborator UNKNOWN

• Clinical Research and Trials Unit (Norfolk & Norwich University Hospital, UK)

  collaborator OTHER

• Medway Maritime Hospital

  collaborator UNKNOWN

• Northwick Park Hospital

  collaborator OTHER

• Homerton University Hospital

  collaborator UNKNOWN

• City Hospital Birmingham

  collaborator UNKNOWN

• Warwick Hospital

  collaborator UNKNOWN

• University Hospital Coventry

  collaborator UNKNOWN

• University of Birmingham

  lead OTHER

Principal Investigators

• Matthew JA Wilson · Sheffield Teaching Hospitals NHS Foundation Trust

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

16 Years

Sex

FEMALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2014-05-31

Primary Completion

2016-09-30

Completion

2016-09-30

Countries

• United Kingdom

Study Locations