To test the feasibility and acceptability of a newly developed model of neonatal nurse-controlled analgesia to manage pain in the post-operative infant.
The study utilised a single-centre two-arm parallel, unblinded randomised controlled external pilot trial design.
The pilot trial was conducted in a surgical neonatal tertiary intensive care unit in Brisbane, Australia. Eligible infants were randomised to receive either post-operative pain management care via a model of neonatal nurse-controlled analgesia or standard care. Feasibility and acceptability were the primary outcomes. Seven feasibility outcomes were assessed by a traffic light system to delineate progression to a larger trial. Acceptability and clinical utility of the model of care by staff were assessed by feedback from an anonymous questionnaire that was administered at the completion of the trial period. Secondary outcomes included parental attitudes and perceptions of post-operative pain management to help establish primary outcomes for a larger randomised controlled trial.
Overall staff found the formalised model beneficial for managing post-operative pain but found the complexity of the model and ability to titrate analgesia based only on documented pain scores barriers requiring further consideration. Three of the seven feasibility outcomes failed to reach ‘greenlight’ targets to progress to a larger trial with adherence to the model, and the proportion of eligible infants not recruited was allocated a ‘redlight’. Secondary outcomes were comparable and support future study.
This pilot feasibility study has shown that a model of neonatal nurse-controlled analgesia can be safely implemented and utilised in the post-operative care of the surgical neonate. Further exploration of the barriers to model adherence and recruitment is warranted before a future larger trial is undertaken.
Though not all primary outcomes reached an acceptable range for further progression, this pilot feasibility study provided invaluable learning and has provided direction for future research into the provision of a family integrated and responsive model of analgesia.
This study is reported in line with the Consolidated Standards of Reporting Trials (CONSORT): Extension to randomised pilot and feasibility trial and the TIDieR Checklist (Template for Intervention, Description and Replication).
No patient or public contribution was utilised for this study.
Trial Registration: ACTRN12623000643673—the trial was prospectively registered
To implement strategies to improve the care of patients with acute pain in the emergency department (ED).
Pre–post implementation study using a Type 2 hybrid effectiveness–implementation design.
Implementation strategies were introduced and monitored through the Ottawa Model of Research Uses' assessment, monitoring and evaluation cycles, supported by focused and sustained facilitation.
Improvements in time-to-analgesia within 30 min (21%–27%), administration of nurse-initiated analgesia (NIA) (17%–27%) and measurement of pain (65%–75%) were achieved post-implementation. NIA was the strongest predictor of receiving analgesia within 30 min. Adoption of pain interventions into practice was not immediate yet responded to sustained facilitation of implementation strategies.
Collaboration with local clinicians to introduce simple interventions that did not disrupt workflow or substantially add to workload were effective in improving analgesia administration rates, and the proportion of patients receiving analgesia within 30 min. The assessment, monitoring and evaluation cycles enabled agile and responsive facilitation of implementation activities within the dynamic ED environment. Improvements took time to embed into practice, trending upward over the course of the implementation period, supporting the sustained facilitation approach throughout the study.
Sustained adoption of evidence-based pain interventions into the care of people presenting to the ED with acute pain can be achieved through sustained facilitation of implementation. NIA should be at the centre of acute pain management in the ED.
This study addressed the lingering gap between evidence and practice for patients with acute pain in the ED. Implementation of locally relevant/informed implementation strategies supported by focused and sustained facilitation improved the care of patients with acute pain in the ED. This research will have an impact on people presenting to EDs with acute pain, and on clinicians treating people with acute pain in the ED. Relevant equator guidelines were followed and the StaRI reporting method used.
No Patient or Public Contribution in this study.