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Compares treatment options for Procedural Pain
Official title Intranasal Versus Intravenous Fentanyl For Procedural Analgesia in Preterm Neonates
ClinicalTrials.gov ID: NCT07190625
What this study is testing
What is fentanyl intravenous?
fentanyl intravenous is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for procedural pain.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
- This is a blinded study.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages up to 28
You may be able to join if
- 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.
You likely can't join if
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Cairo, Egypt
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, up to 28 days. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Cairo, Egypt. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.