Clinical Trial

Intranasal Versus Intravenous Fentanyl For Procedural Analgesia in Preterm Neonates

Recruiting Early Phase 1
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Record status
This record was last updated October 1, 2025 (before its estimated March 1, 2026 completion). Its status may not reflect the trial's current state.
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.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2025-09-20.
Trial Details
NCT Number NCT07190625
Lead Sponsor Ain Shams University
Conditions Procedural Pain
Enrollment 75 participants
Start Date 2023-12-24
Primary Completion 2026-03-01 (estimated)
Study Completion 2026-06-01 (estimated)
Updated on ClinicalTrials.gov 2025-10-01