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Needle-Free Lidocaine vs Traditional Anesthesia for Infants

N/A

Waitlist Available

Led By Jamie Laughy, MD

Research Sponsored by University of Oklahoma

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age 0 to 3 months

Infants requiring lumbar puncture for diagnostic or therapeutic purposes

Must not have

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up immediately post-procedure (within 5 minutes after the lumbar puncture)

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to compare the pain control and provider satisfaction between using a needle-free jet-injection system called J-Tip and traditional needle infiltration of lidocaine for infants undergoing lumbar punctures in

Who is the study for?

This trial is for infants who require local anesthesia for lumbar punctures. The study aims to include those who can safely receive lidocaine. Specific inclusion and exclusion criteria details are not provided, but typically would exclude infants with allergies to lidocaine or certain medical conditions.

What is being tested?

The trial is testing the effectiveness of a needle-free jet injection system (J-Tip) using 1% lidocaine against the traditional method of needle infiltration with the same concentration of lidocaine in providing pain relief during lumbar punctures in infants.

What are the potential side effects?

Potential side effects may include localized pain, swelling, or bruising at the site of anesthetic administration. There could also be a risk of allergic reactions to lidocaine in both methods.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am a newborn up to 3 months old.

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My infant needs a lumbar puncture for diagnosis or treatment.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My infant is allergic to lidocaine or the jet injection device.

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My infant has a serious skin infection or rash where the shot will be given.

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My infant has a bleeding disorder.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ during the procedure

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~during the procedure

This trial's timeline: 3 weeks for screening, Varies for treatment, and during the procedure for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Caregiver Satisfaction

Pain Score

Procedure Success Rate

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Traditional needle infiltration of 1% lidocaineExperimental Treatment1 Intervention

Traditional needle infiltration involves injecting 1% lidocaine with a needle to provide local anesthesia before an infant lumbar puncture. This method is the standard practice for pain management in such procedures. Other Names: • traditional needle infiltration of 1% lidocaine

Group II: Needle-Free Jet Injection of 1 % lidocaineExperimental Treatment1 Intervention

Device: Needle-Free Jet Injection The needle-free jet injection device delivers 1 % Lidocaine through high-pressure fluid without the use of a needle. This method aims to reduce the pain associated with needle-based anesthesia during infant lumbar punctures. Other Names: • Jet Injection Device, J-tip

0 / 5Eligibility criteria met