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BACKGROUND:: A pain management protocol was implemented in our Neonatal Intensive Care Unit in 2005, including individual pain assessments and pain treatment guidelines with a decision tree.OBJECTIVES:: To prospectively evaluate the degree of compliance of medical and nursing staff with the pain protocol.METHODS:: Prospectively recorded pain scores (COMFORTneo score) and all prescribed analgesics and sedatives for the calendar year 2011 were retrieved. The primary outcome is the degree of compliance to the protocol with respect to pain assessments and treatment; the secondary outcome consists of reasons for non-compliance.RESULTS:: Of the 732 included patients, 660 (90%) received fewer than the stipulated 3 assessments per day. Eighty-six per cent of all assessments yielded a score between 9 and 14, suggesting a comfortable patient. In cases of high pain scores (≥14), reassessment within 60 minutes took place in 31% of cases and in 40% treatment was started or adjusted. In cases of low pain scores (≤8) during treatment, 13% of the 457 assessments were reassessed within 120 minutes and in 17% a dose reduction was performed.CONCLUSIONS:: Although the majority of pain assessments suggested comfortable patients, there is room for improvement with respect to reassessments after adjustment of analgesic/sedative treatment. Some protocol violations such as oversedation in palliative patients are acceptable but should be well documented.