Status:
COMPLETED
Intranasal Fentanyl in Preterm Infants Undergoing Peripherally Inserted Central Catheter Placement
Lead Sponsor:
Mount Sinai Hospital, Canada
Conditions:
Procedural Pain
Eligibility:
All Genders
Up to 1 years
Phase:
PHASE3
Brief Summary
The purpose of this feasibility clinical trial is to explore the role of intranasal fentanyl for pain associated with PICC placement in preterm infants. The primary goals are identifying whether enoug...
Detailed Description
Infants admitted to the neonatal intensive care unit (NICU) are subjected to multiple painful procedures as part of clinical care. It is established that early and repeated exposure to pain is associa...
Eligibility Criteria
Inclusion
- Infants with a gestational age at birth \< 32 weeks or birth weight \< 1.5 kg
- Infants considered medically appropriate for the study by the most responsible physician
Exclusion
- Infants with choanal atresia, nasal mucosal erosion, or epistaxis
- Infants with facial anomalies
- Infants diagnosed with genetic conditions known to affect neurological development or severe (grade ≥ III) intraventricular hemorrhage
- Infants receiving continuous intravenous infusions or scheduled enteral doses of opioids or sedatives within 12 hours of PICC placement
- Infants with cardiopulmonary instability managed with inotropes, vasopressors, phosphodiesterase enzyme inhibitors, or neuromuscular blocking agents at the time of PICC placement
- Infants prescribed strong CYP3A4 inhibitors (clarithromycin, itraconazole, ketoconazole, posaconazole, ritonavir, voriconazole) at the time of PICC placement
- Infants diagnosed with bronchopulmonary dysplasia (need for supplemental oxygen or need for ventilatory support at 36 weeks corrected gestational age)
- Infants with a previous documented adverse reaction to any formulation of fentanyl
- Each eligible infant will be enrolled for one PICC placement only during the study period
Key Trial Info
Start Date :
August 9 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 9 2025
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT06590870
Start Date
August 9 2024
End Date
February 9 2025
Last Update
February 20 2025
Active Locations (1)
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1
Mount Sinai Hospital
Toronto, Ontario, Canada, M5G 1X5