drugset / Trial / NCT07190625

Intranasal Versus Intravenous Fentanyl For Procedural Analgesia in Preterm Neonates

NCT07190625

Phase 0 Recruiting 75 enrolled Ain Shams University
RandomizedParallel-groupOpen-labelSupportive care

Summary

Pain in neonatal life has profound long-term developmental impacts, so pain control is crucial. The intranasal (IN) route is a minimally invasive method for rapidly delivering fentanyl to provide short-term analgesia and sedation in adults and pediatrics, but few data exist about its use in neonates. Meanwhile, intravenous fentanyl is widely used in sedation and pain management. Using intranasal fentanyl as an analgesic in preterm neonates may provide a rapid, effective, noninvasive route for administration.

Timeline

Start
2023-12-24
Primary completion
2026-03-01
Completion
2026-06-01

Drugs

EvaluationDrugModalityDoseRoute
Comparator Fentanyl Other / unclassified 1 ug/kg Intravenous
Comparator Fentanyl Other / unclassified 1.5 ug/kg Intravenous

Indications

No indication recorded.