318 - Safety and Efficacy of Intranasal Fentanyl Use in Early Infancy: A Single-Center Experience

Publication Number: 4312.318

Sophie Zhai, Medical College of Wisconsin, Wauwatosa, WI, United States; Kathleen Meskin, Medical College of Wisconsin, New Berlin, WI, United States; Erwin T. Cabacungan, Medical College of Wisconsin, Children's Wisconsin, Milwaukee, WI, United States; Vijender R. Karody, Medical College of Wisconsin, Milwaukee, WI, United States

Background: Effective pain and sedation management is essential for infants in the neonatal intensive care unit (NICU), yet non-invasive analgesic options are limited. Intranasal fentanyl (INF) offers rapid onset and easy administration without the need for intravenous (IV) access, making it a promising alternative for procedural and pain management. However, evidence supporting its safety and efficacy in early infancy remains scarce.

Objective: To evaluate the clinical use, safety, and efficacy of INF in NICU infants.

Design/Methods: We conducted an IRB-exempt retrospective chart review of INF administrations among infants aged ≤6 months admitted to a Level IV NICU between April 2017 and December 2024. Demographics, clinical indications, concomitant sedatives or analgesics, vital signs, pain scores (Neonatal Pain, Agitation, and Sedation Scale [NPASS]; Premature Infant Pain Profile [PIPP]; and Face, Legs, Activity, Cry, Consolability [FLACC]), and adverse events were extracted. Paired t-tests compared pre- and post-administration vital signs, and Wilcoxon signed-rank tests compared pain scores.

Results: Out of 9,965 infants, 40 (0.4%) received 53 INF doses (mean = 1.4 ± 0.45 µg/kg), with increasing use over time (Figure 1B); recipient characteristics are shown in Figure 1A. Most infants (82.5%) lacked IV access at administration. The primary indications were peripherally inserted central catheter (PICC) placement (47.2%) and intubation (32.1%) (Figure 2). Nearly all doses (94.3%) were delivered using a mucosal atomization device, and most infants (95%) received a single INF dose per event. Concomitant sedatives included midazolam (34%), morphine (9.4%), IV fentanyl (3.8%), vecuronium (3.8%), and lorazepam (1.9%). No cardiorespiratory or gastrointestinal adverse events were observed. Vital signs remained stable, with no significant differences in heart rate, respiratory rate, or mean blood pressure pre- and post-INF administration (Table 1). Among 35 infants with recorded pain scores, NPASS scores (n = 27, p = 0.053) trended lower after INF, suggesting improved comfort without hemodynamic instability (Table 1).

Conclusion(s): INF was well tolerated and appeared effective for procedural and pain management in NICU infants, with no adverse events or significant hemodynamic changes, even when used alongside other sedatives. Given its favorable safety profile and ease of administration, INF may be a practical, non-invasive alternative to IV opioids. Further studies are needed to evaluate dosing, pharmacokinetics, and direct comparisons with IV opioids to define the role of INF in neonatal procedural and pain management.

Figure 1. Overview of clinical characteristics and INF use trends among NICU infants
(A) Demographics and clinical characteristics of NICU infants who received INF. (B) INF administrations over time, by quarter (2017-2024), with dotted line indicating a linear, upward trend.

Figure 2. Clinical indications for INF administration among NICU infants
Pie chart shows the distribution of clinical indications for INF use, including procedural, analgesic, sedation, and others (N = 53).

Table 1. Vital signs and pain scores pre- and post-INF administration
Table compares vital signs and pain scores before and after INF administration. Paired t-tests were used for heart rate, respiratory rate, and mean blood pressure; † denotes Wilcoxon signed-rank test used for NPASS and FLACC scores.