Pain Management Methods for Clubfoot

Overseen By Brooke Turner

Age: < 18

Sex: Any

Trial Phase: Phase 4

Sponsor: Vanderbilt University Medical Center

Disqualifiers: Age over 6 weeks, Previous treatment, Neuromuscular conditions, others

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

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 10 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the most effective pain relief method for infants with clubfoot undergoing percutaneous tendoachilles lengthening, a minor surgery to lengthen the tendon at the back of the heel. It compares L.M.X.4 cream, which takes longer to work, with a quick-acting, needle-free injection system called the J-tip with Xylocaine. The main goal is to determine if the J-tip provides equal or better pain relief without additional side effects. Infants under six weeks old with untreated clubfoot visiting a specific clinic for this procedure may be eligible to participate. As a Phase 4 trial, this research aims to understand how an already FDA-approved treatment can benefit more patients.

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications.

What is the safety track record for these pain management methods?

Research has shown that the J-Tip needle-free injection system with Xylocaine, a numbing medicine, is well-tolerated. This system uses a quick burst of air to deliver the medicine under the skin. Studies have found it can control pain better than some creams, with few side effects reported.

L.M.X.4 cream is another option for numbing the skin. It is widely used and generally safe, though some people may experience minor skin redness or irritation.

Both treatments aim to relieve pain without major side effects. The J-Tip might work faster, while L.M.X.4 cream remains a well-known and trusted choice. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Most treatments for clubfoot focus on surgical interventions and lengthy casting processes. However, researchers are excited about exploring pain management methods like the J-Tip with Xylocaine MPF and L.M.X.4 cream with saline injection. The J-Tip device offers a needle-free delivery of anesthetic, reducing the discomfort and anxiety often associated with injections. Additionally, using topical anesthetics like L.M.X.4 cream provides a non-invasive approach to pain relief. These methods have the potential to make treatment experiences less stressful and more comfortable for patients, especially children, compared to traditional surgical options.

What evidence suggests that this trial's pain management methods could be effective for clubfoot?

Research has shown that the J-Tip needle-free injection system can relieve pain more effectively than creams like L.M.X.4 for certain procedures. In this trial, one group of participants will receive the J-Tip with 0.25mL of 1% Xylocaine MPF. Studies have found this combination effectively controls pain for infants undergoing a procedure to lengthen the Achilles tendon. The J-Tip provides rapid pain relief, working in just 1-2 minutes. Another group will receive L.M.X.4 cream with a J-Tip saline injection, which typically takes 30-60 minutes to take effect. The J-Tip delivers medication deeper into the skin, potentially enhancing its effectiveness. Overall, these findings suggest that J-Tip could be a faster and possibly more effective option for managing pain in this situation. ^{1 2 3 4 6}

Who Is on the Research Team?

Jeffrey Martus, MD

Principal Investigator

Vanderbilt University Medical Center

Are You a Good Fit for This Trial?

This trial is for infants under 6 weeks old with idiopathic clubfoot who are getting in-clinic Achilles Tenotomy at Vanderbilt DOT 4 Clinic. It's not for those who've had previous clubfoot treatments, are older than 6 weeks at the start of casting, or have neuromuscular conditions like spina bifida.

Inclusion Criteria

I am scheduled for an Achilles tendon cutting procedure in a clinic.

My baby is under 6 weeks old and has clubfoot.

Patients presenting to Vanderbilt DOT 4 Clinic for care

Exclusion Criteria

My doctor advises against certain throat procedures due to my age or size.

I have a condition affecting my muscles or nerves, like spina bifida.

You have had treatment for clubfoot in the past.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either L.M.X.4 Cream or J-Tip Xylocaine MPF injection for pain management during in-office percutaneous TAL

10 weeks

Weekly visits for casting and procedure

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• In-Office Procedure
• Needle-Free Injection System
• Pain Management
• Percutaneous Tendoachilles Lengthening
• Topical Anesthetic Cream

Trial Overview The study compares two pain relief methods during a foot procedure for clubfoot: LMX4 cream (a topical anesthetic) and J-Tip needle-free injection system with lidocaine. The goal is to see which provides better pain control without increasing adverse events.

How Is the Trial Designed?

Group I: J-Tip with 0.25mL of 1% Xylocaine MPF with placebo cream Experimental Treatment 1 Intervention

Group II: L.M.X.4 cream with J-Tip saline injection Active Control 1 Intervention

Who Is Running the Clinical Trial?

Vanderbilt University Medical Center

Lead Sponsor

Trials

922

Recruited

939,000+

Citations

1. trialx.com trialx.com/clinical-trials/listings/238037/comparison-study-of-lmx4-cream-versus-j-tip-needle-free-injection-system-with-lidocaine-for-in-office-pat-for-clubfoot/

Comparison Study of LMX4 Cream Versus J-Tip Needle ... Multiple studies have demonstrated the J-Tip to provide greater pain control than other pharmaceutical options, including EMLA cream and ...

2. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/84/NCT04766684/Prot_SAP_002.pdf

Comparison Study of LMX4 Cream Versus J-Tip Needle ... J-tip 1% Xylocaine. MPF Injection, provides the greatest pain relief to infants with clubfoot undergoing an in- office percutaneous TAL. Page 6 ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/31795756/

The Anesthetic Effectiveness of J-Tip Needle-Free Injection ... The use of JNFS loaded with 1% buffered lidocaine may reduce pain associated with trigger finger injections, although our results did not find a statistically ...

4. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/84/NCT04766684/ICF_003.pdf

Comparison Study of LMX4 Cream Versus J-Tip Needle ... If your child is assigned to the needle-free injection system, it may provide greater pain relief to your child during the procedure. The.

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8647309/

The Anesthetic Effectiveness of J-Tip Needle-Free Injection ... Conclusions: The use of JNFS loaded with 1% buffered lidocaine may reduce pain associated with trigger finger injections, although our results did not find a ...

6. jtip.com jtip.com/

Virtually Painless The J-Tip - Needle-Free Injection System The needle-free device called the J-Tip can be used before an IV procedure to help reduce pain during an IV by delivering an anesthetic effect with-in one to ...