The RESPITE trial: remifentanil intravenously administered patient-controlled analgesia (PCA) versus pethidine intramuscular injection for pain relief in labour: study protocol for a randomised controlled trial

• Published in: Current controlled trials in cardiovascular medicine 2016-12, Vol.17 (1), p.591, Article 591
• Main Authors: Wilson, Matthew, MacArthur, Christine, Gao Smith, Fang, Homer, Leanne, Handley, Kelly, Daniels, Jane
• Format: Article
• Language: English
• Subjects: Adult; Analgesia, Obstetrical - adverse effects; Analgesia, Obstetrical - methods; Analgesia, Patient-Controlled - adverse effects; Analgesia, Patient-Controlled - methods; Analgesics, Opioid - administration & dosage; Analgesics, Opioid - adverse effects; Anesthesia; Childbirth & labor; Clinical Protocols; Comparative analysis; Contraindications; Drug dosages; Drug therapy; England; Epidural; Fecal incontinence; Female; Humans; Infusions, Intravenous; Injections, Intramuscular; Labor complications; Labor Pain - diagnosis; Labor Pain - drug therapy; Meperidine; Meperidine - administration & dosage; Meperidine - adverse effects; Narcotics; Pain; Pain Measurement; Patient Satisfaction; Piperidines - administration & dosage; Piperidines - adverse effects; Pregnancy; Remifentanil; Research Design; Study Protocol; Surveys and Questionnaires; Time Factors; Treatment Outcome; Vagina; Womens health; Young Adult
• ISSN: 1745-6215; 1745-6215
• DOI: 10.1186/s13063-016-1708-3

The commonest opioid used for pain relief in labour is pethidine (meperidine); however, its effectiveness has long been challenged and the drug has known side effects including maternal sedation, nausea and potential transfer across the placenta to the foetus. Over a third of women receiving pethidine require an epidural due to inadequate pain relief. Epidural analgesia increases the risk of an instrumental vaginal delivery and its associated effects. Therefore, there is a clear need for a safe, effective, alternative analgesic to pethidine. Evidence suggests that remifentanil patient-controlled analgesia (PCA) reduces epidural conversion rates compared to pethidine; however, no trial has yet investigated this as a primary endpoint. We are, therefore, comparing pethidine intramuscular injection to remifentanil PCA in a randomised controlled trial. Women in established labour, requesting systemic opioid pain relief, will be randomised to either intravenously administered remifentanil PCA (intervention) or pethidine intramuscular injection (control) in an unblinded, 1:1 individual randomised trial. Following informed consent, 400 women in established labour, who request systemic opioid pain relief, from NHS Trusts across England will undergo a minimised randomisation by a computer or automated telephone system to either pethidine or remifentanil. In order to balance the groups this minimisation is based on four parameters; parity (nulliparous versus multiparous), maternal age (