A Neonatal Nurse-Controlled Model of Analgesia to Manage Post-Operative Pain in the Surgical Neonate: A Pilot Randomised Controlled Trial

AimTo test the feasibility and acceptability of a newly developed model of neonatal nurse-controlled analgesia to manage pain in the post-operative infant.DesignThe study utilised a single-centre two-arm parallel, unblinded randomised controlled external pilot trial design.MethodsThe 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.ResultsOverall 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.ConclusionThis 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.ImpactThough 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.Reporting MethodThis 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).Public or Patient ContributionNo patient or public contribution was utilised for this study. Trial Registration: ACTRN12623000643673-the trial was prospectively registeredPublic or Patient ContributionNo patient or public contribution was utilised for this study. Trial Registration: ACTRN12623000643673-the trial was prospectively registered