Comparison of Sufentanil versus Fentanyl in Ventilated Term Neonates

 

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Abstract

Background: Increasingly frequent applications of opioid analgesics in neonatal intensive care require the evaluation of efficacy and side effects.

Patients: Mechanically ventilated term neonates were consecutively enrolled.

Methods: In a double-blind randomized trial 20 newborns received a continuous intravenous infusion of fentanyl (n=10) or sufentanil (n=10) in an assumed equipotent dose of 7:1. The analgesic dose was individually adjusted according to sedation scores. The period between cessation of analgesic medication and successful extubation (weaning time), adverse drug effects and urinary cortisol concentrations were evaluated.

Results: No significant difference of weaning time was seen between fentanyl and sufentanil group (mean weaning time (±SD) of fentanyl group 520±381 min, median 380 min; sufentanil group 585±531 min, median 405 min, p=0.78, 2-tailed U-Test, Mann and Whitney). The mean opioid dose resulted in a 10:1 ratio (fentanyl 4.11 μg/(kg×h) vs sufentanil 0.41 μg/(kg×h)). We found no marked differences in sedation levels, blood pressure, heart rate, oxygenation index, co-medication or urinary cortisol levels. In both groups similar adverse effects were assessed including respiratory depression, mild withdrawal symptoms or decrease of gastrointestinal motility.

Conclusion: In our study sufentanil did not reduce the weaning period in ventilated term neonates when compared to fentanyl. The equipotent dose ratio for fentanyl/sufentanil was 10:1. According to sedation scores both substances provided effective pain and stress protection.

Zusammenfassung

Hintergrund: Die zunehmende Anzahl von Opioiden im Rahmen der Neugeborenenintensivtherapie legt die Untersuchung von Wirkung und potentiellen Nebenwirkungen nahe.

Patienten: Reife, aufgrund von postnatalen Atemstörungen beatmete Neugeborene wurden konsekutiv eingeschlossen.

Methode: In einer randomisierten, doppelblinden Studie erhielten 20 Neugeborene eine kontinuierliche intravenöse Infusion mit Fentanyl (n=10) oder Sufentanil (n=10) in einer angenommenen Äquivalentdosis von 7:1. Die analgetische Dosis wurde individuell gemäß Sedierungsscore angepaßt. Bewertet wurde der Zeitraum zwischen Beendigung der Analgesie und erfolgreicher Extubation (weaning), Nebenwirkungen und die Cortisol-Konzentration im Urin.

Ergebnisse: Im Vergleich Fentanyl/Sufentanil fanden sich keine signifikanten Unterschiede in Bezug auf das Weaning (mittlere Weaning Dauer (±SD) der Fentanylgruppe 520±381 min, Median 380 min; Sufentanilgruppe 585±531 min, Median 405 min, p=0.78, 2-seitiger U-Test, Mann und Whitney). Die mittlere Opioiddosis betrug für Fentanyl 4.11 μg/(kg×h) vs. Sufentanil 0.41 μg/(kg×h) entsprechend einem Verhältnis von 10:1. Wir beobachten keine nennenswerten Unterschiede bezüglich Sedierungsniveau, Blutdruck, Herzfrequenz, Oxigenierungsindex, Komedikation oder Urin-Kortisolspiegel. Beide Patientengruppen wiesen vergleichbare Charakteristika im Hinblick auf Atemdepression, milde Entzugserscheinungen oder Reduktion der gastrointestinalen Motilität auf.

Schlußfolgerung: In unserem Kollektiv konnte eine Reduktion der Weaningdauer nach Einsatz von Sufentanil im Vergleich zu Fentanyl nicht nachgewiesen werden. Die Äquipotenzdosis betrug 10:1 Fentanyl/Sufentanil. Gemäß den Sedierungsscores erzielen beide Substanzen eine Abschirmung vor Stressfaktoren.

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Correspondence

Prof. Dr. Bernhard Roth

Department of Neonatology and Pediatric Intensive Care Medicine

Children`s Hospital

University of Cologne

Kerpenerstr. 62

50937 Cologne

Germany

Email: bernhard.roth@uk-koeln.de