NCT07190625 Intranasal Versus Intravenous Fentanyl For Procedural Analgesia in Preterm Neonates
| NCT ID | NCT07190625 |
| Status | Recruiting |
| Phase | EARLY_Phase 1 |
| Sponsor | Ain Shams University |
| Condition | Procedural Pain |
| Study Type | INTERVENTIONAL |
| Enrollment | 75 participants |
| Start Date | 2023-12-24 |
| Primary Completion | 2026-03-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 75 participants in total. It began in 2023-12-24 with a primary completion date of 2026-03-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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 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.
Contact & Investigator
Passant Fahmy, M.Sc
PRINCIPAL INVESTIGATOR
Assisstant lecturer
Frequently Asked Questions
Who can join the NCT07190625 clinical trial?
This trial is open to participants of all sexes, up to 28 Days, studying Procedural Pain. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07190625 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07190625 currently recruiting?
Yes, NCT07190625 is actively recruiting participants. Contact the research team at Passant.Osama@med.asu.edu.eg for enrollment information.
Where is the NCT07190625 trial being conducted?
This trial is being conducted at Cairo, Egypt.
Who is sponsoring the NCT07190625 clinical trial?
NCT07190625 is sponsored by Ain Shams University. The principal investigator is Passant Fahmy, M.Sc at Assisstant lecturer. The trial plans to enroll 75 participants.