Your session is about to expire
← Back to Search
Pain Management Methods for Clubfoot
Phase 4
Recruiting
Led By Jeffrey Martus, MD
Research Sponsored by Vanderbilt University Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients undergoing in-clinic Achilles Tenotomy
Clubfoot patients less than 6 weeks of age at start of casting
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, before cast placement to tenotomy procedure at the end of casting, approximately 10 weeks.
Awards & highlights
Study Summary
This trial is testing which pain management method, L.M.X.4 Cream vs. J-tip 1% Xylocaine MPF Injection, is better for infants with clubfoot undergoing an in-office percutaneous TAL. The hypothesis is that J-tip 1% Xylocaine MPF injection will provide equal or greater pain control when compared to L.M.X.4 cream.
Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Possible side effects may include skin reactions where the cream or injection was applied, such as redness or swelling. There might also be differences in how well each method controls pain during the procedure.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am scheduled for an Achilles tendon cutting procedure in a clinic.
Select...
My baby is under 6 weeks old and has clubfoot.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, before cast placement to tenotomy procedure at the end of casting, approximately 10 weeks.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, before cast placement to tenotomy procedure at the end of casting, approximately 10 weeks.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
FLACC (Face, Legs, Activity, Cry, Consolability) Scale
Pulse Oximetry
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: J-Tip with 0.25mL of 1% Xylocaine MPF with placebo creamExperimental Treatment1 Intervention
Group II: L.M.X.4 cream with J-Tip saline injectionActive Control1 Intervention
Find a Location
Who is running the clinical trial?
Vanderbilt University Medical CenterLead Sponsor
857 Previous Clinical Trials
672,103 Total Patients Enrolled
Jeffrey Martus, MDPrincipal InvestigatorVanderbilt University Medical Center
1 Previous Clinical Trials
7 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My doctor advises against certain throat procedures due to my age or size.I am scheduled for an Achilles tendon cutting procedure in a clinic.My baby is under 6 weeks old and has clubfoot.I have a condition affecting my muscles or nerves, like spina bifida.You have had treatment for clubfoot in the past.I am over 6 weeks old and have clubfoot.
Research Study Groups:
This trial has the following groups:- Group 1: J-Tip with 0.25mL of 1% Xylocaine MPF with placebo cream
- Group 2: L.M.X.4 cream with J-Tip saline injection
Awards:
This trial has 2 awards, including:- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is enrollment presently available for this research trial?
"The clinical trial is still seeking participants; the initial listing was posted on June 1st 2021 and revised as recently as October 16th 2022."
Answered by AI
How many patients are enrolled in this investigation?
"Affirmative. Information on clinicaltrials.gov confirms that this medical research, which was initially posted June 1st 2021, is actively selecting participants. Approximately 58 individuals need to be recruited from one location."
Answered by AI
What potential risks may be associated with a 0.25mL dose of 1% Lidocaine and placebo cream via the J-Tip delivery method?
"Our team at Power believes J-Tip with 0.25mL of 1% Lidocaine with placebo cream to be quite secure, and awarded it a 3 on the safety scale due to its Phase 4 classification which implies official approval."
Answered by AI
Recent research and studies
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger