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Intranasal Versus Intravenous Fentanyl For Procedural Analgesia in Preterm Neonates

RecruitingEARLY Phase 1Ages any - 28 DaysAllAin Shams University
NCT07190625 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
Inclusion Criteria: * 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 Criteria: * 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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What it tests

  • fentanyl intravenous
  • Fentanyl intranasal using atomizer
  • fentanyl intranasal direct
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Where

1 site
Ain Shams University
Cairo, Egypt
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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