Status:
RECRUITING
Intranasal Versus Intravenous Fentanyl For Procedural Analgesia in Preterm Neonates
Lead Sponsor:
Ain Shams University
Conditions:
Procedural Pain
Eligibility:
All Genders
Up to 28 years
Phase:
EARLY_PHASE1
Brief 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 shor...
Detailed Description
The aim of this study is to evaluate the effect of intranasal fentanyl versus the intravenous route for procedural pain management in preterm neonates as assessed by pain scoring system before and aft...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- known contraindications for fentanyl use, such as fentanyl hypersensitivity and liver failure.
- Known contraindication for intranasal administration of drugs (choanal atresia, nasal mucosal erosion, and epistaxis)
- Post-surgical patients.
- Patients sedated by fentanyl infusion / midazolam infusion.
- Evidence of neurological disease with disturbed conscious level, such as intraventricular hemorrhage grade III or IV, hypoxic ischemic encephalopathy, or inborn error of metabolism.
Key Trial Info
Start Date :
December 24 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2026
Estimated Enrollment :
75 Patients enrolled
Trial Details
Trial ID
NCT07190625
Start Date
December 24 2023
End Date
June 1 2026
Last Update
October 1 2025
Active Locations (1)
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1
Ain Shams University
Cairo, Egypt