Highlights
- •Analysis of a remifentanil patient-controlled analgesia (PCA) database.
- •RemiPCA SAFE Network has monitored clinical use of remifentanil PCA since 2009.
- •5740 remifentanil PCA applications at 31 hospitals analysed between 2010 and 2015.
- •No need for maternal ventilation or cardiopulmonary resuscitation was reported.
- •Remifentanil PCA applied within the context of the network is safe and effective.
Abstract
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.
Keywords
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Article info
Publication history
Published online: December 21, 2018
Accepted:
December 15,
2018
Identification
Copyright
© 2018 Elsevier Ltd. All rights reserved.
