Background The use of opioids as sedatives is necessary for agitated neonates undergoing mechanical ventilation (MV) with respiratory distress syndrome (RDS) in a neonatal intensive care unit (NICU), to facilitate the procedure of MV and enhance the ventilator-patient synchrony, in addition to pain relief.

Purpose To perform a cost-effectiveness analysis of morphine versus fentanyl in agitated neonates with RDS undergoing MV in the NICU setting.

Material and methods A retrospective cost-effectiveness analysis of critically ill neonates with RDS receiving morphine versus fentanyl at a Women’s Wellness and Research Centre. The clinical data of neonates were extracted from the medical records of patients within the 2014–2016 period. A decision analytic model, from the hospital perspective, was constructed to follow the possible consequences of sedation. The primary endpoints were the successful drug sedation rate, based on the Premature Infant Pain Profile (PIPP) scoring scale, and the overall direct medical cost of therapy of managing acute agitation in the neonates. A study population size of 124 neonates was calculated to achieve results with 80% power and P0.05 significance. Sensitivity analyses were conducted to enhance the robustness of conclusions against input uncertainties, and increase the generalisability of results.

Results All baseline demographic characteristics were not significantly different between both groups. A multivariate analysis of covariance model demonstrated that the statistical difference between morphine and fentanyl did not statistically change after accounting for baseline differences of values of PIPP scores, birthweight and gestational age (P-value=1.00). Morphine achieved a sedation success of 68%, versus 43% with fentanyl, risk ratio 1.72, 95% CI 1.16 to 2.56, P-value=0.0075. Morphine was associated with a minimal incremental cost-effectiveness ratio of $135 per additional case of sedation over fentanyl. Based on uncertainty analyses, however, this higher morphine cost was reported in only 2% of patient cases. Sensitivity analyses demonstrated insensitivity of the study model to the study input uncertainties, except for the NICU stay and cost of MV.

Conclusion This is the first cost-effectiveness evaluation of morphine versus fentanyl in a NICU. Morphine significantly improved sedation over fentanyl. There is a 98% probability that morphine is dominant over fentanyl.

References and/or acknowledgements We acknowledge the receipt of study funding by the Office of Academic Research.

No conflict of interest.