Clinical trial NCT06590870: Intranasal Fentanyl in Preterm Infants Undergoing Peripherally Inserted Central Catheter Placement
Official title: Intranasal Fentanyl for Procedural Analgesia in Preterm Infants Undergoing Peripherally Inserted Central Catheter Placement (INFENT PICC): a Feasibility Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Procedural Pain
Keywords: Fentanyl
Intranasal Drug Administration
Preterm Infants
Neonatal Intensive Care Unit
Peripherally Inserted Central Catheter Line Insertion
Lead sponsor: Mount Sinai Hospital, Canada
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 8
Sex: ALL
Minimum age (years): 0
Maximum age (years): 1
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Recruitment rate
timeFrame: 6 month study period
measure: Completeness of data collection for pain score assessment
timeFrame: At the needle insertion phase of the PICC placement
Secondary outcomes:
measure: Number of adverse events
timeFrame: Up to 6 hours after intranasal intervention administration
measure: Acceptability and adoption of intranasal medications
timeFrame: Immediately after the PICC placement
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Mount Sinai Hospital
state: Ontario
Study officials:
affiliation: MOUNT SINAI HOSPITAL
name: Vibhuti Shah
role: PRINCIPAL_INVESTIGATOR
References: