Intranasal vs IV fentanyl for procedural pain in preterm newborns
Intranasal Versus Intravenous Fentanyl For Procedural Analgesia in Preterm Neonates : A Randomized Controlled Trial
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 |
| Enrollment | 75 (estimated) |
| Ages | N/A to 28 Days |
| Sex | All |
| Sponsor | Ain Shams University Academic / other |
| Locations | 1 site (Cairo) |
| Trial ID | NCT07190625 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Cairo
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.