Needle-Free Lidocaine vs Traditional Anesthesia for Infants

Recruiting in Palo Alto (17 mi)

Overseen byJamie Laughy, MD

Age: < 18

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: University of Oklahoma

No Placebo Group

Trial Summary

What is the purpose of this trial?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.

Eligibility Criteria

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.

Inclusion Criteria

Parental/guardian consent obtained

I am a newborn up to 3 months old.

My infant needs a lumbar puncture for diagnosis or treatment.

Exclusion Criteria

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

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

My infant has a bleeding disorder.

+1 more

Participant Groups

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.

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