Not Yet RecruitingNot Applicable

Needle-Free Lidocaine Injection vs Traditional Local Anesthesia in Infant Lumbar Puncture

United States100 participantsStarted 2024-11

Plain-language summary

We hypothesize that the J-Tip needle-free jet-injection system offers comparable pain control and greater provider satisfaction due to its less invasive nature compared to traditional needle infiltration of 1% lidocaine in infants undergoing lumbar punctures. Our aim is to evaluate the efficacy and feasibility of different local anesthetic techniques in the ED setting by comparing traditional lidocaine needle infiltration with J-tip.

Who can participate

Age range

1 Day – 3 Months

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.

Infants requiring lumbar puncture for diagnostic or therapeutic purposes * Age 0 to 3 months * Parental/guardian consent obtained Exclusion Criteria: * Infants with known allergy or hypersensitivity to lidocaine or components of the needle-free jet injection device * Infants with significant skin infection or dermatitis at the site of injection * Infants with coagulopathy or any bleeding disorder * Infants with any other condition that, in the opinion of the investigator, would make participation in the study unsafe or not in the best interest of the infant

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

Pain Score

Timeframe: Immediately post-procedure (within 5 minutes after the lumbar puncture)

Procedure Success Rate

Timeframe: During the procedure

Caregiver Satisfaction

Timeframe: Within 1 hour post-procedure

Trial details

NCT IDNCT06552351

SponsorUniversity of Oklahoma

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-08-01

Contact for this trial

Valorie Owens, MSW

405-271-2429 Valorie-Owens@ouhsc.edu

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