Intranasal Fentanyl in Preterm Infants Undergoing Peripherally Inserted Central Catheter Placement

NCT ID: NCT06590870

Last Updated: 2025-02-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-08-09
• Study Completion Date: 2025-02-09

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 enough infants join the study and complete the study procedures.

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 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.

Conditions

Procedural Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Intranasal fentanyl plus standard of care

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.

Group Type: EXPERIMENTAL

Fentanyl

Intervention Type: DRUG

The fentanyl solution for administration will be prepared by diluting 2 mL of fentanyl 50 µg/mL with 8 mL of normal saline (bacteriostatic 0.9% sodium chloride) for a fentanyl solution of 10 µg/mL.

Intranasal normal saline plus standard of care

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.

Group Type: PLACEBO_COMPARATOR

Normal saline

Intervention Type: DRUG

The normal saline solution for administration will be bacteriostatic 0.9% sodium chloride.

Interventions

Fentanyl

The fentanyl solution for administration will be prepared by diluting 2 mL of fentanyl 50 µg/mL with 8 mL of normal saline (bacteriostatic 0.9% sodium chloride) for a fentanyl solution of 10 µg/mL.

Intervention Type: DRUG

Normal saline

The normal saline solution for administration will be bacteriostatic 0.9% sodium chloride.

Intervention Type: DRUG

Other Intervention Names

Fentanyl Injection BP; Bacteriostatic sodium chloride injection USP

Eligibility Criteria

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

• Minimum Eligible Age: 0 Years
• Maximum Eligible Age: 1 Year
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mount Sinai Hospital, Canada

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Vibhuti Shah

Role: PRINCIPAL_INVESTIGATOR

MOUNT SINAI HOSPITAL

Locations

Mount Sinai Hospital

Toronto, Ontario, Canada

Countries

Canada

References

Tabbara N, McLeod SL, Taddio A, Shah V. Intranasal Fentanyl in Preterm Infants Undergoing Peripherally Inserted Central Catheter Placement (INFENT PICC): A Feasibility Randomized Controlled Trial. Children (Basel). 2025 Aug 30;12(9):1156. doi: 10.3390/children12091156.

Reference Type: DERIVED

PMID: 41007021 (View on PubMed)

Other Identifiers

46585

Identifier Type: OTHER

Identifier Source: secondary_id

24-0072-A

Identifier Type: -

Identifier Source: org_study_id