Procedural PainPhase 3INFENT PICCNCT06590870
Intranasal Fentanyl in Preterm Infants Undergoing Peripherally Inserted Central Catheter Placement
A Phase 3 study testing Fentanyl and Normal saline in people with Procedural Pain, run by Mount Sinai Hospital, Canada at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 0 years to 1 year
- Conditions the study is for
- Procedural Pain
- What is being tested?
- Fentanyl and Normal saline
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 8 participants
- Where
- 1 siteCanada
- Study dates
- 9 Aug 2024to 9 Feb 2025
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 years to 1 year
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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
- Being tested
- Fentanyl, Normal saline
- Keywords
- Fentanyl, Intranasal Drug Administration, Preterm Infants, Neonatal Intensive Care Unit, Peripherally Inserted Central Catheter Line Insertion
- Medical subject headings
- Pain, Procedural
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FentanylDrug
Also called Fentanyl Injection BP
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.
Normal salineDrug
Also called Bacteriostatic sodium chloride injection USP
The normal saline solution for administration will be bacteriostatic 0.9% sodium chloride.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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).
Measured: At the needle insertion phase of the PICC placement
Secondary outcomes (2)
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
Measured: 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
Measured: Immediately after the PICC placement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start9 Aug 2024
- Primary completion9 Feb 2025
- Study completion9 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Procedural PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mount Sinai Hospital, Canada
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Vibhuti Shah, Principal investigator, MOUNT SINAI HOSPITAL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06590870
- Sponsor's protocol ID
- 24-0072-A
- Other IDs
- 46585
- Acronym
- INFENT PICC
- Status last verified
- Aug 2024
- First submitted
- 6 Aug 2024
- Last updated
- 20 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 41007021
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intranasal Fentanyl for Procedural Analgesia in Preterm Infants Undergoing Peripherally Inserted Central Catheter Placement (INFENT PICC): a Feasibility Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06590870
- Acronym / sponsor ID
- INFENT PICC / 24-0072-A
- Conditions
- Procedural Pain
- Keywords
- Fentanyl, Intranasal Drug Administration, Preterm Infants, Neonatal Intensive Care Unit, Peripherally Inserted Central Catheter Line Insertion
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Mount Sinai Hospital, CanadaUniversity, hospital or other
- Study start
- 9 Aug 2024 (actual)
- Primary completion
- 9 Feb 2025 (actual)
- Study completion
- 9 Feb 2025 (actual)
- First posted
- 19 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intranasal fentanyl plus standard of care | Experimental | Drug: FentanylOne 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. |
| Intranasal normal saline plus standard of care | Placebo comparator | Drug: Normal salineOne 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. |
Who may qualify
- Ages
- 0 years to 1 year
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FentanylAlso: Fentanyl Injection BPThe 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. | Drug | Intranasal fentanyl plus standard of care |
| Normal salineAlso: Bacteriostatic sodium chloride injection USPThe normal saline solution for administration will be bacteriostatic 0.9% sodium chloride. | Drug | Intranasal normal saline plus standard of care |
Primary outcome
Recruitment rate
Time frame: 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
Time frame: 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).
2 secondary outcomes
Number of adverse events
Time frame: Up to 6 hours after intranasal intervention administration
Acceptability and adoption of intranasal medications
Time frame: Immediately after the PICC placement
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2025.
- Derived from this study: PubMed 41007021Tabbara 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vibhuti Shah principal investigator
MOUNT SINAI HOSPITAL
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Fentanyl and Normal saline in people with Procedural Pain, run by Mount Sinai Hospital, Canada at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment rate (time frame: 6 month study period). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06590870, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2025.