Procedural Pain
Conditions
Keywords
Fentanyl, Intranasal Drug Administration, Preterm Infants, Neonatal Intensive Care Unit, Peripherally Inserted Central Catheter Line Insertion
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.
Interventions
DRUGFentanyl
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.
DRUGNormal saline
The normal saline solution for administration will be bacteriostatic 0.9% sodium chloride.
Sponsors
Mount Sinai Hospital, Canada
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
0 Years to 1 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recruitment rate | 6 month study period | Number of infants assessed for eligibility, number of infants approached for consent, number of enrolled infants, and number of participants completing study procedures |
| Completeness of data collection for pain score assessment | At the needle insertion phase of the PICC placement | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of adverse events | Up to 6 hours after intranasal intervention administration | 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 |
| Acceptability and adoption of intranasal medications | Immediately after the PICC placement | Survey of healthcare team members capturing experience with intranasal intervention administration, including barriers and enablers to use intranasal medications |
Countries
Canada
Outcome results
None listed