Intranasal Versus Intravenous Fentanyl For Procedural Analgesia in Preterm Neonates
ConditionProcedural Pain
Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
AgeUp to 28
SponsorAin Shams University
About this trial
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
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- fentanyl intravenous
- Fentanyl intranasal using atomizer
- fentanyl intranasal direct
Treatment groups
75 Participants
are divided into 3 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov