Intranasal vs IV fentanyl for procedural pain in preterm newborns
Official title: Intranasal Versus Intravenous Fentanyl For Procedural Analgesia in Preterm Neonates : A Randomized Controlled Trial
Run by Ain Shams University · NCT07190625 · Data updated 2026-11-12
This trial will test whether a nasal spray or an intravenous dose of fentanyl works better to relieve short-term procedure pain in preterm newborns.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Ages | Any age to 28 Days |
| Sex | All |
| Enrollment | 75 (estimated) |
| Sponsor | Ain Shams University Academic / other |
| Locations | 1 site (Cairo) |
| Status | Recruiting |
| Started | December 24, 2023 |
| Main results expected | March 1, 2026 |
| Study ends | June 1, 2026 |
| Registry record updated | October 1, 2025 |
| Trial ID | NCT07190625 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Preterm neonates 28–36 weeks gestation undergoing procedures such as central venous access insertion, elective endotracheal intubation, or lumbar puncture who have no contraindications to fentanyl or intranasal delivery.
✕Probably not a fit
Infants with fentanyl hypersensitivity, liver failure, nasal contraindications (e.g., choanal atresia, mucosal erosion, active epistaxis), post-surgical status, ongoing fentanyl/midazolam infusions, or severe neurologic impairment are unlikely to be eligible or to benefit from this approach.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
Preterm neonates (28–36 weeks gestation) undergoing short painful procedures are randomized in a single-blind design to one of three arms: intranasal fentanyl delivered with an atomizer, intranasal fentanyl delivered by direct instillation, or standard intravenous fentanyl. Intranasal doses are 1.5 µg/kg per dose (one dose, with a second dose allowed after 5 minutes if needed, maximum two doses) and the IV dose is 1 µg/kg as standard care. Pain scores are recorded before and after the procedure by a clinician who is different from the researcher performing randomization and administration. Clinical history, exam findings, type and attempts of procedure, and dosing details are collected to compare short-term analgesic effect between routes.
Why it matters
Potential benefit: If successful, this could offer a rapid, effective, noninvasive option for short-term pain relief in preterm infants and reduce the need for IV access for procedural analgesia.
How similar studies have gone: Intranasal fentanyl has provided rapid short-term analgesia in adults and older children, but its use in preterm neonates is novel and data in this population are limited.
Who can join: the full rules
Show full inclusion / exclusion criteria
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.
Where it's running
-
Ain Shams University
Cairo, Egypt Recruiting
Study contacts
- Principal investigator: Passant Fahmy, M.Sc — Assisstant lecturer
- Study coordinator: Passant Osama Fahmy, M.Sc
- Email: Passant.Osama@med.asu.edu.eg
- Phone: 01066724641
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.