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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a needle-free device can reduce pain during anesthesia for infants undergoing a lumbar puncture (a procedure to collect spinal fluid). The study compares the traditional needle method with a new tool that uses pressure to inject lidocaine (a numbing medicine) without a needle. It targets infants up to 3 months old who require this procedure for medical reasons. Parental consent is necessary for infant participation. As an unphased trial, this study provides an opportunity to contribute to innovative research that could make medical procedures less painful for infants.

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 prior data suggests that the needle-free jet injection system is safe for infants?

Research shows that the needle-free jet-injection system with 1% lidocaine is generally well-tolerated. Studies have found that this method can reduce pain compared to traditional needle injections. For example, one study observed that using the needle-free system for spinal taps in infants resulted in less crying, suggesting it might be less painful.

The traditional method of using a needle to inject 1% lidocaine is already widely used and considered safe. It remains the standard approach for managing pain in procedures like spinal taps.

Both the needle-free and traditional methods use the same anesthetic, lidocaine, which is commonly used and generally safe when administered correctly. Studies have not reported any major side effects for either method, indicating that both options appear safe for use in infants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about needle-free jet injection of 1% lidocaine for infants because it offers a pain-free alternative to traditional needle infiltration. Unlike the standard method, which involves a needle to deliver anesthesia, the needle-free jet injection uses high-pressure fluid to administer lidocaine without breaking the skin. This approach aims to significantly reduce the discomfort associated with needle-based anesthesia, making procedures like lumbar punctures less traumatic for infants.

What evidence suggests that this trial's treatments could be effective for infant lumbar punctures?

This trial will compare two methods of delivering lidocaine for infant lumbar punctures: needle-free jet injection and traditional needle infiltration. Research has shown that using a needle-free jet injection system can make procedures like lumbar punctures less painful for infants. Studies have found that this method causes less pain than traditional needles. In one study, infants cried for a shorter time with the needle-free method, suggesting it might be more comfortable. This method also works faster than other topical solutions. Overall, these findings suggest that needle-free jet injections could effectively reduce pain during infant procedures. ^{1 2 3 4 6}

Who Is on the Research Team?

Jamie Laughy, MD

Principal Investigator

University of Oklahoma

Are You a Good Fit for This Trial?

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 for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/29160002/

Needle-free Lidocaine vs Topical Anesthesia for Infant LP We compared a needle-free jet-injection system (J-Tip) with 1% buffered lidocaine to topical anesthetic (TA) cream for local anesthesia in infant LPs.

2. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/full/10.1111/acem.13351

A Randomized Double Blind Trial of Needle‐free Injected ... We compared a needle-free jet-injection system (J-Tip) with 1% buffered lidocaine to topical anesthetic (TA) cream for local anesthesia in infant LPs.

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0735675716002126

Lidocaine Jet Injection vs Needle Infiltration for Lumbar Puncture This study shows that performing LP by lidocaine jet injection might be less painful than lidocaine needle infiltration. Lidocaine jet injection might be safer ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT01628874

Jet Injection of 1% Buffered Lidocaine Versus Topical ... Our study aims to evaluate the efficacy of the J-Tip in lumbar punctures. It offers the advantage of providing much faster anesthesia compared to topical creams ...

5. semanticscholar.org semanticscholar.org/paper/40120d82c7385b1656a3f76cbce1906dd9458290

Needle-Free Jet Injection of Lidocaine for Local Anesthesia ... Needle-free injection of 1% buffered lidocaine administered before needle insertion for LP in infants reduces pain and length of cry, compared with normal ...

6. withpower.com withpower.com/trial/phase-anaesthesia-therapy-8-2024-7738f

Needle-Free Lidocaine vs Traditional Anesthesia for Infants We hypothesize that the J-Tip needle-free jet-injection system offers comparable pain control and greater provider satisfaction due to its less invasive ...