RecruitingEarly Phase 1NCT07190625

Intranasal Versus Intravenous Fentanyl For Procedural Analgesia in Preterm Neonates

Intranasal Versus Intravenous Fentanyl For Procedural Analgesia in Preterm Neonates : A Randomized Controlled Trial

Sponsor

Ain Shams University

Enrollment

75 participants

Start Date

Dec 24, 2023

Study Type

INTERVENTIONAL

Conditions

Procedural Pain

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.

Eligibility

Max Age: 28 Days

Inclusion Criteria2

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 Criteria5

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.

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