Intranasal Fentanyl in Preterm Infants Undergoing Peripherally Inserted Central Catheter Placement (NCT06590870) | Clinical Trial Compass
CompletedPhase 3
Intranasal Fentanyl in Preterm Infants Undergoing Peripherally Inserted Central Catheter Placement
Canada8 participantsStarted 2024-08-09
Plain-language 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 enough infants join the study and complete the study procedures.
Who can participate
Age range0 Years – 1 Year
SexALL
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Inclusion Criteria:
* 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 Criteria:
* 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
What they're measuring
1
Recruitment rate
Timeframe: 6 month study period
2
Completeness of data collection for pain score assessment
Timeframe: At the needle insertion phase of the PICC placement