Actively Recruiting

Early Phase 1
Age: 0 - 28Days
All Genders
NCT07190625

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

Age: 0 - 28Days
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 1 location

1

Ain Shams University

Cairo, Egypt

Actively Recruiting

Loading map...

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

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here