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Background: During labour, remifentanil patient-controlled analgesia is used as an alternative to neuraxial analgesia. Remifentanil is associated with hypoventilation and respiratory depression but the frequency of serious maternal and neonatal adverse events is unknown. The aim of this study was to estimate the number of serious adverse events attributed to the use of remifentanil patient-controlled analgesia during labour in The Netherlands and to investigate the circumstances (e.g. monitoring, practice deviations) of these events and the subsequent management., Methods: In a nationwide survey among obstetricians, anaesthetists and clinical midwives the frequency of serious adverse events was assessed. A questionnaire was sent by email to all 61 Dutch hospitals in which remifentanil patient-controlled analgesia is, or has been, available for labour analgesia. All reported cases were assessed independently by two expert teams., Results: We received information from all hospitals. After independent assessments, 17 cases of single maternal desaturation; 10 maternal cases of apnoea, bradycardia and/or cardiac arrest; and two neonatal cases of respiratory depression, over a period of more than 10 years of remifentanil patient-controlled analgesia use, were identified as a serious adverse event. All serious adverse events were resolved without irreversible damage., Conclusions: The risk of a potentially life-threatening serious adverse event attributed to remifentanil patient-controlled analgesia seems to be low. All patients recovered without deficit. Adherence to strict monitoring and the attendance of trained healthcare providers is required to safely use remifentanil for labour analgesia., (Copyright © 2018 Elsevier Ltd. All rights reserved.)

Background: Intravenous remifentanil patient-controlled analgesia (PCA) has been routinely available for labouring women in our unit since 2004, the regimen using a 40 µg bolus available two minutely on demand, continuous pulse oximetry and mandatory one-to-one care. We examined remifentanil use and compared, with the other analgesic options available in our unit, outcomes such as mode of delivery, Apgar scores, neonatal resuscitation and admission to the neonatal intensive care unit., Methods: We retrospectively identified women who delivered in our unit between 2005 and 2014 and received remifentanil, diamorphine or epidural analgesia during labour. Data were drawn from the Northern Ireland Maternity System electronic database, which records birth details from all obstetric units in Northern Ireland. Additional data were identified from paper survey forms, completed by the midwife post delivery for all women who received remifentanil in our unit. Outcomes were compared between women who received remifentanil, diamorphine or an epidural technique for labour analgesia., Results: Over the 10-year period, remifentanil was the most popular form of analgesia, being selected by 31.9% (8170/25617) women. Compared with women selecting diamorphine or epidural analgesia, those having remifentanil had similar rates of instrumental and operative delivery. Neonatal Apgar scores were also similar. Neonatal resuscitation or neonatal unit admission were not more likely in women choosing remifentanil PCA., Conclusion: We found remifentanil PCA to be neither less safe nor associated with poorer outcomes than other analgesic options offered in our unit, when used within our guidelines for more than a 10-year period., (Copyright © 2019 Elsevier Ltd. All rights reserved.)

Background: The RemiPCA SAFE Network was established to set standards and monitor maternal and neonatal outcomes when using remifentanil for labour analgesia. The aim of this analysis was to describe the development of the network standard and to report maternal and neonatal outcome data, including severe adverse events., Methods: Data sets of the RemiPCA SAFE Network database from the initial six consecutive years (2010-2015) were retrospectively analysed. The data were analysed on an annual basis and set in context with changes of the network standard, i.e. adaptations of the network's standard operating procedure. Main outcomes reported are maternal and neonatal data regarding effectiveness and safety, such as satisfaction, need for bag/mask ventilation and/or cardiopulmonary resuscitation., Results: Among 5740 data sets, no need for maternal ventilation or cardiopulmonary resuscitation was registered. Neonatal cardiopulmonary resuscitations, potentially related to remifentanil, occurred in 0.3%. In parallel with adaptations of the network standard, a moderate rate of maternal hypoxia (oxygen saturation <94% in 24.7%) was found, together with a low rate of supplemental oxygen requirement in neonates (5.0%)., Conclusion: The RemiPCA SAFE Network data show that remifentanil patient-controlled analgesia can be applied safely. There is bias when data from real clinical settings are analysed retrospectively. Notwithstanding, the approach taken by the RemiPCA SAFE Network, with constant, systematic and standardised evaluation of multiple parameters during the course of labour, might identify trends and anomalies and guide the development and application of safety standards, when translating knowledge from scientific trials into clinical practice., (Copyright © 2018 Elsevier Ltd. All rights reserved.)