Background Implementation of sedation protocols based on regular sedation assessment using item-based scales can improve sedative treatment in children. There is a lack of validated tools to assess sedation in neonates.

Objective To validate the Neonatal Pain, Agitation and Sedation Scale (N-PASS) for the assessment of sedation in preterm and term neonates.

Methods The Nurse Interpretation of Sedation Score (NISS) was used to validate the N-PASS with regard to neonatal sedation. Paired assessments of both the N-PASS and the NISS were performed in 50 sedated neonates from 23 to 44 weeks’ postmenstrual age.

Results A total set of 503 paired observations were included into analysis. The median N-PASS scores were significantly different for the three NISS categories (over-sedation (-8), adequate sedation (-2), under-sedation (0); p <.0001). Inter-observer agreement for the N-PASS sedation subscale was excellent (linearly weighted Cohen’s Kappa:. 93), as was the internal consistency estimated by a Cronbach’s alpha of 0.88, which increased to.90 when the vital sign item was excluded from the N-PASS. There was no risk of under-sedation in patients with an N-PASS score <-5 and no risk of over-sedation with an N-PASS score > -2. The N-PASS reliably detected over-sedation. Detection of under-sedation was markedly improved by simultaneous assessment of N-PASS pain scores which were significantly different in patients being considered adequately sedated vs. inadequately sedated (median N-PASS pain subscale score: 2 vs. 5).

Conclusion The N-PASS meets the requirements of a valid clinical tool to assess sedation in neonates and may facilitate the use of sedation algorithms in the neonatal intensive care unit.