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

Intranasal Fentanyl for Procedural Analgesia in Preterm Infants Undergoing Peripherally Inserted Central Catheter Placement (INFENT PICC): a Feasibility Randomized Controlled Trial

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.

Study Overview

• Status: Completed
• Conditions: Procedural Pain
• Intervention / Treatment: Drug: Fentanyl; Drug: Normal saline

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.

• Study Type: Interventional
• Enrollment (Actual): 8
• Phase: Phase 3

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5G 1X5
      • Mount Sinai Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: 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.; Other Names: Fentanyl Injection BP
Placebo Comparator: 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.	Drug: Normal saline; The normal saline solution for administration will be bacteriostatic 0.9% sodium chloride.; Other Names: Bacteriostatic sodium chloride injection USP

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of adverse events	Number of apneas (cessation of breathing > 20 seconds), number of bradycardias (heart rate < 100 beats per minute), number of desaturations (oxygen saturation < 80%), chest wall rigidity, escalation in ventilatory support, and need for other analgesia	Up to 6 hours after intranasal intervention administration
Acceptability and adoption of intranasal medications	Survey of healthcare team members capturing experience with intranasal intervention administration, including barriers and enablers to use intranasal medications	Immediately after the PICC placement

Collaborators and Investigators

• Sponsor: Mount Sinai Hospital, Canada
• Investigators: Principal Investigator: Vibhuti Shah, Mount Sinai Hospital

Study record dates

Study Major Dates

• Study Start (Actual): August 9, 2024
• Primary Completion (Actual): February 9, 2025
• Study Completion (Actual): February 9, 2025

Study Registration Dates

• First Submitted: August 6, 2024
• First Submitted That Met QC Criteria: September 6, 2024
• First Posted (Actual): September 19, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 18, 2025
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Keywords: Fentanyl; Neonatal Intensive Care Unit; Preterm Infants; Peripherally Inserted Central Catheter Line Insertion; Intranasal Drug Administration
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Pain, Procedural; Physiological Effects of Drugs; Peripheral Nervous System Agents; Anesthetics; Central Nervous System Depressants; Sensory System Agents; Analgesics; Analgesics, Opioid; Narcotics; Adjuvants, Anesthesia; Anesthetics, Intravenous; Anesthetics, General; Fentanyl
• Other Study ID Numbers: 24-0072-A; 46585 (Other Identifier: University of Toronto Research Ethics Board)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No