|Abstract||Background. Neonates with respiratory distress syndrome (RDS), admitted to the neonatal intensive care unit (NICU) at the Women’s Hospital (WH) in Qatar, often require mechanical ventilation (MV) to maintain ventilator synchrony. No economic evaluations of morphine or fentanyl as stands alone or in combination with midazolam for sedation in NICU exist in the literature. The objective of this study was to evaluate the clinical and economic impact of sedatives in mechanically ventilated neonates with RDS in the Qatari NICU.
Methods. A comparative retrospective cost-effectiveness study sought to evaluate 126 critically ill neonates receiving morphine versus fentanyl, 64 patients receiving morphine monotherapy versus morphine plus midazolam, and 268 patients receiving fentanyl monotherapy versus fentanyl plus midazolam at WH in Hamad Medical Corporation (HMC), Qatar. Available medical records in the duration from October 2014 to January 2016 were utilized. Decision analytic models from the hospital perspective were designed to measure all the possible consequences of all comparisons. 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. Sample size calculations were to achieve results with 80% power and a significance level of 0.05. Sensitivity analyses were conducted to enhance the robustness and generalizability of the results.
Results. Morphine monotherapy achieved sedation success in 68% of patients with an incremental cost-effectiveness ratio (ICER) of QAR 490.36 per additional sedation success compared to 43% with fentanyl. Morphine also produced better sedation in neonates with an ICER of QAR 21, 206.85 compared to its combination with midazolam (66% versus 34%). The fentanyl monotherapy dominated the combination of fentanyl and midazolam, with a net cost saving of QAR 43,811.83 per patient and a 51% successful sedation rate, compared to 33%. Here, the study group of fentanyl plus midazolam combination did not achieve the calculated sample size and, hence, the evaluation of this group is piloting in nature. Sensitivity analyses demonstrated robustness of all study conclusions.
Conclusion. The current study is the first clinical and economic analysis of morphine, fentanyl, and midazolam in the NICU in literature, including in Qatar. Morphine monotherapy produced higher sedation levels over fentanyl monotherapy and the morphine plus midazolam combination but with higher costs. Fentanyl monotherapy had cost savings over its combination with midazolam, while its reported higher clinical effectiveness over the combination cannot be interpreted due to the limited sample size.