CompletedNot Applicable

Study Comparing Ultrasound-guided FICNB Block to Systemic Analgesia in Treatment of Pediatric Femur Fracture

United States, Australia114 participantsStarted 2022-06-01

Plain-language summary

The goal of this prospective observational study is to compare pain control strategies in children with femur fractures. Researchers will compare ultrasound-guided fascia iliaca compartment nerve block to IV pain control alone. The main questions it aims to answer are: * Are ultrasound-guided fascia iliaca compartment nerve blocks as effective as IV pain control in controlling pain? * Do patients who receive an ultrasound-guided fascia iliaca compartment nerve block require less opioid pain medication than those that don't? Participants will be asked to provide pain scores during their Emergency Department stay. Participants parents will be asked to complete a brief survey at the time their child is leaving the Emergency Department.

Who can participate

Age range

4 Years – 17 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Acute femur fracture (less than 24 hours from initial injury) * Glasgow Coma Scale of 14 or greater at time of enrollment Exclusion Criteria: * Allergy or hypersensitivity to local anesthetic agents * Pregnant * Prisoner * Neurovascular injury to the affected limb * Bilateral femur fractures * Confirmed, or significant clinical suspicion for, injury to their head, neck, chest, abdomen, back or pelvis * Imaging suggestive of a head, neck, chest, abdomen, back or pelvic injury * Laboratory results suggestive of a head, neck, chest, abdomen, back or pelvic injury * A fracture not limited to the extremities (i.e. vertebral compression fracture) * A significantly displaced extremity fractures (aside from the primary femur fracture) * An open fracture (aside from the primary femur fracture) * An additional fracture to the limb of the primary femur fracture (i.e. tibia fracture in the same leg as the primary femur fracture).

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

60 Minute Pain Score

Timeframe: 60 minutes after enrollment.

Trial details

NCT IDNCT05947292

SponsorZachary Binder

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2024-06-30

View on ClinicalTrials.gov More Femur Fracture trials