Objective: Intranasal fentanyl's (INF) effectiveness is established using highly concentrated INF (HINF). Standard concentration INF (SINF) is more widely available. We aimed to illustrate the equivalence of SINF to HINF.
Methods: Double-blinded randomized controlled trial was used within a children's hospital ED. Children aged 3-15 years with fractures were randomized to SINF or HINF. Outcome measures included pain scores at time zero and every 10 min until 30 min. Additional analgesic agents were noted.
Results: Data in 189 children (91 HINF, 98 SINF) were obtained. Pre-analgesia median VAS was 80.0 mm (interquartile range [IQR] 60.0-95.5) in SINF, 77.5 mm (IQR 60.0-100) in HINF. At 10 min median VAS was 49.5 mm (IQR 26.5-68.5) and 43.0 mm (IQR 15.2-66.0), respectively, at 20 min 27.5 mm (IQR 18.5-56.5) and 35.0 mm (IQR 9.0-57.0) and at 30 min 20.0 mm (IQR 10.0-46.0) and 21.5 mm (IQR 4.75-51.0). Each agent demonstrated significant decrease in pain scores (median decrease 40 mm, P = 0.000). Additional analgesia was given in 67 (42 SINF, 25 HINF) (P = 0.028). The decrease in pain scores between children < and ≥50 kg in SINF was significant both overall (P = 0.005) and between 10 and 20 min (P = 0.003). There was no difference in HINF at any time by weight.
Conclusions: The two concentrations of INF were equivalent in reducing pain, with a trend to increased oral additional agents in the more dilute solution. The widespread use of this readily available analgesic in the standard concentration can be supported, particularly in patients <50 kg.
© 2011 The Authors. EMA © 2011 Australasian College for Emergency Medicine and Australasian Society for Emergency Medicine.