Needle-Free Lidocaine vs Traditional Anesthesia for Infants

Overseen By Valorie Owens, MSW

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: University of Oklahoma

Disqualifiers: Lidocaine allergy, Skin infection, Bleeding disorder, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

Duration: 1 day

100 Participants Needed

Trial Summary

Do I need to stop my baby's current medications for this trial?

The trial information does not specify whether infants need to stop taking their current medications. It's best to discuss this with the trial team or your baby's doctor.

What data supports the effectiveness of the needle-free lidocaine treatment for infants?

Research suggests that needle-free jet injection of local anesthetics, like lidocaine, can be a valuable option in pediatrics, with reports indicating minimal discomfort and lower risks compared to traditional needle methods. However, studies comparing needle-free methods to traditional anesthesia in children have shown that traditional methods are often more effective and preferred. ^{1 2 3 4 5}

Is needle-free lidocaine safe for use in children?

Needle-free lidocaine delivery is generally considered safe for children, with reports indicating minimal discomfort and fewer risks compared to traditional needle methods. However, it may cause skin changes during certain procedures, like skin biopsies, so it's not recommended for those. ^{1 6 7 8 9}

How does the needle-free jet injection of lidocaine differ from traditional anesthesia methods for infants?

The needle-free jet injection of lidocaine is unique because it delivers anesthesia without using a needle, reducing pain and discomfort compared to traditional needle injections. This method uses high pressure to push the anesthetic into the skin, offering a potentially quicker and less painful alternative for infants. ^{1 2 6 9 10}

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.

Research Team

Jamie Laughy, MD

Principal Investigator

University of Oklahoma

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.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Infants receive local anesthesia via either the J-Tip needle-free jet injection or traditional needle infiltration before lumbar puncture

1 day

1 visit (in-person)

Follow-up

Participants are monitored for pain levels and procedure success immediately after the lumbar puncture

1 hour

1 visit (in-person)

Treatment Details

Interventions

• Needle-Free Jet Injection of 1% Lidocaine
• Traditional Needle Infiltration of 1% Lidocaine

Trial Overview 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.

Participant Groups

Group I: Traditional needle infiltration of 1% lidocaine Experimental Treatment 1 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 % lidocaine Experimental Treatment 1 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

Who Is Running the Clinical Trial?

University of Oklahoma

Lead Sponsor

Trials

484

Recruited

95,900+

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

'Needle-free' delivery of local anesthesia: a valuable option in pediatrics. [2018]

2. United States pubmed.ncbi.nlm.nih.gov

Comparison of acceptance, preference, and efficacy between jet injection INJEX and local infiltration anesthesia in 6 to 11 year old dental patients. [2022]

3. Germany pubmed.ncbi.nlm.nih.gov

V. A new route, jet injection of lidocaine for skin wheal for painless intravenous catheterization. [2018]

4. Germany pubmed.ncbi.nlm.nih.gov

Jet or conventional local anaesthesia? A randomized controlled split mouth study. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

A novel needle-free powder lidocaine delivery system for rapid local analgesia. [2013]

6. Singapore pubmed.ncbi.nlm.nih.gov

Clinical evaluation of the efficacy of anesthesia and patient preference using the needle-less jet syringe in pediatric dental practice. [2019]

7. United States pubmed.ncbi.nlm.nih.gov

A randomized, double-blind controlled study of jet lidocaine compared to jet placebo for pain relief in children undergoing needle insertion in the emergency department. [2013]

8. United States pubmed.ncbi.nlm.nih.gov

Cutaneous histologic artifact associated with the use of a needle-free anesthesia device for skin biopsy. [2013]

9. United States pubmed.ncbi.nlm.nih.gov

Painless intravenous catheterization by intradermal jet injection of lidocaine: a randomized trial. [2019]

10. United States pubmed.ncbi.nlm.nih.gov

A Randomized Double Blind Trial of Needle-free Injected Lidocaine Versus Topical Anesthesia for Infant Lumbar Puncture. [2019]