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Opioid
Intranasal Fentanyl for Procedural Pain (INFENT PICC Trial)
Phase 3
Recruiting
Led By Vibhuti Shah
Research Sponsored by Mount Sinai Hospital, Canada
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Infants with a gestational age at birth < 32 weeks or birth weight < 1.5 kg
Be younger than 18 years old
Must not have
Infants with choanal atresia, nasal mucosal erosion, or epistaxis
Infants diagnosed with genetic conditions known to affect neurological development or severe (grade ≥ III) intraventricular hemorrhage
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 month study period
Awards & highlights
Pivotal Trial
Summary
This trial aims to see if using a nasal spray called fentanyl can help reduce pain in preterm infants when they have a PICC line put in. The main goals are to see if they can
Who is the study for?
This trial is for preterm infants who need a PICC (a type of long-term IV) placed. The study aims to see if enough babies can join and finish the study procedures.
What is being tested?
The trial is testing intranasal fentanyl, a pain medication, against normal saline (saltwater solution). It's to see if fentanyl can help manage pain during PICC placement in these infants.
What are the potential side effects?
Fentanyl may cause side effects like slowed breathing, drowsiness, or decreased heart rate. Normal saline typically has no side effects but might cause irritation at the site of administration.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My baby was born before 32 weeks or weighed less than 1.5 kg.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
My infant has a blocked nasal passage or nosebleeds.
Select...
My infant has a genetic condition affecting brain development or severe brain bleeding.
Select...
My infant is on heart or lung support medication at the time of PICC placement.
Select...
My infant had a bad reaction to fentanyl before.
Select...
My infant needed extra oxygen or breathing support at 36 weeks old.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 month study period
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 month study period
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Completeness of data collection for pain score assessment
Recruitment rate
Secondary study objectives
Acceptability and adoption of intranasal medications
Number of adverse events
Side effects data
From 2009 Phase 4 trial • 237 Patients • NCT01795898100%
Aneurysm ruptured
54%
Dizziness
39%
Nausea
26%
Vomiting
16%
Somnolence
5%
Pruritus
2%
Insomnia
2%
Headache
1%
Weakness
1%
Palpitation
1%
Rashes
1%
Chest pain
1%
Cold clammy perspiration
1%
Flushing
1%
Muscle trembling
1%
Constipation
100%
80%
60%
40%
20%
0%
Study treatment Arm
Fentanyl
Awards & Highlights
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Intranasal fentanyl plus standard of careExperimental Treatment1 Intervention
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.
Group II: Intranasal normal saline plus standard of carePlacebo Group1 Intervention
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Fentanyl
2019
Completed Phase 4
~1920
Find a Location
Who is running the clinical trial?
Mount Sinai Hospital, CanadaLead Sponsor
204 Previous Clinical Trials
69,167 Total Patients Enrolled
Vibhuti ShahPrincipal InvestigatorMOUNT SINAI HOSPITAL