Intranasal Fentanyl in Preterm Infants Undergoing Peripherally Inserted Central Catheter Placement (INFENT PICC)

Mount Sinai Hospital, Canada

Status and phase: Completed; Phase 3

Conditions: Procedural Pain

Treatments: Drug: Normal saline; Drug: Fentanyl

Study type: Interventional

Funder types: Other

Identifiers

NCT06590870

24-0072-A

46585 (Other Identifier)

Details and patient eligibility

About

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.

Full 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 associated with negative consequences. However, pain management strategies continue to be underutilized in NICUs worldwide.

Placement of a PICC is a clinically essential painful procedure in infants requiring prolonged intravenous access. The procedure can cause moderate to severe pain. To date, the optimal medication for procedural analgesia during PICC placement is not known.

Intranasal fentanyl has emerged as an option for pain management in infants admitted to the NICU. In preparation for a future definitive clinical trial, this is a feasibility clinical trial exploring the role of intranasal fentanyl for procedural analgesia in preterm infants undergoing PICC placement.

Enrollment: 8 patients

Sex: All

Ages: Under 1 year old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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8 participants in 2 patient groups, including a placebo group

Intranasal fentanyl plus standard of care

Experimental group

Description:

One dose of fentanyl 1.5 µg/kg via a mucosal atomization device 10 minutes before the PICC placement. Standard of care includes sucrose 24% oral solution with or without non-nutritive sucking.

Treatment:

Drug: Fentanyl

Intranasal normal saline plus standard of care

Placebo Comparator group

Description:

One dose of normal saline (volume equivalent to fentanyl 1.5 µg/kg) via a mucosal atomization device 10 minutes before the PICC placement. Standard of care includes sucrose 24% oral solution with or without non-nutritive sucking.

Treatment:

Drug: Normal saline