Actively Recruiting
Intranasal Versus Intravenous Fentanyl For Procedural Analgesia in Preterm Neonates
Led by Ain Shams University · Updated on 2025-10-01
75
Participants Needed
1
Research Sites
127 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Intranasal Versus Intravenous Fentanyl For Procedural Analgesia in Preterm Neonates
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Preterm neonates with gestational age between 28 and 36 weeks gestation
- Undergoing painful procedures such as central venous access insertion, elective endotracheal intubation, and lumbar puncture
You will not qualify if you...
- Known allergy to fentanyl or liver failure
- Known nasal issues preventing drug administration (choanal atresia, nasal mucosal erosion, epistaxis)
- Recent surgery
- Sedation by fentanyl or midazolam infusion
- Neurological diseases causing disturbed consciousness such as severe intraventricular hemorrhage, hypoxic ischemic encephalopathy, or inborn errors of metabolism
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Ain Shams University
Cairo, Egypt
Actively Recruiting
Research Team
P
Passant Osama Fahmy, M.Sc
CONTACT
R
Rabab Gameel Allam, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
3
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