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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 below

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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:

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My infant has a blocked nasal passage or nosebleeds.

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My infant has a genetic condition affecting brain development or severe brain bleeding.

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My infant is on heart or lung support medication at the time of PICC placement.

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My infant had a bad reaction to fentanyl before.

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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

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 month study period for reporting.

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 • NCT01795898

100%

Aneurysm ruptured

54%

Dizziness

39%

Nausea

26%

Vomiting

16%

Somnolence

Pruritus

Insomnia

Headache

Weakness

Palpitation

Rashes

Chest pain

Cold clammy perspiration

Flushing

Muscle trembling

Constipation

100%

80%

60%

40%

20%

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

0 / 6Eligibility criteria met