Intranasal Fentanyl in Preterm Infants Undergoing Peripherally Inserted Central Catheter Placement

NCT06590870 | Completed Phase 3

• 2 other identifiers: 24-0072-A46585
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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.

Conditions

Procedural Pain

Keywords

Fentanyl; Intranasal Drug Administration; Preterm Infants; Neonatal Intensive Care Unit; Peripherally Inserted Central Catheter Line Insertion

Outcome Measures

Primary Outcomes (2)

• Recruitment rate

  Number of infants assessed for eligibility, number of infants approached for consent, number of enrolled infants, and number of participants completing study procedures

  6 month study period

• Completeness of data collection for pain score assessment

  Premature infant pain profile-revised (PIPP-R) scores using video recordings. PIPP-R scores range from 0-21 and are interpreted as no pain (score of 0), mild pain (score 1-6), moderate pain (score 7-12), and severe pain (score 13-21).

  At the needle insertion phase of the PICC placement

Secondary Outcomes (2)

• Number of adverse events

  Up to 6 hours after intranasal intervention administration

• Acceptability and adoption of intranasal medications

  Immediately after the PICC placement

Study Arms (2)

Intranasal fentanyl plus standard of care

EXPERIMENTAL

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.

Drug: Fentanyl

Intranasal normal saline plus standard of care

PLACEBO COMPARATOR

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.

Drug: Normal saline

Interventions

Fentanyl 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.

Also known as: Fentanyl Injection BP

Intranasal fentanyl plus standard of care

Normal saline DRUG

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

Also known as: Bacteriostatic sodium chloride injection USP

Intranasal normal saline plus standard of care

Eligibility Criteria

• Age: 0 Years - 1 Year
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mount Sinai Hospital, Canada: lead

Study Sites (1)

Mount Sinai Hospital

Toronto, Ontario, M5G 1X5, Canada

Location

Related Publications (1)

• 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.

  PMID: 41007021 DERIVED

MeSH Terms

Conditions

Pain, Procedural

Interventions

Fentanyl; Saline Solution

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Vibhuti Shah

  MOUNT SINAI HOSPITAL

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 6, 2024
• First Posted: September 19, 2024
• Study Start: August 9, 2024
• Primary Completion: February 9, 2025
• Study Completion: February 9, 2025
• Last Updated: February 20, 2025

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)