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Needle-Free jet injection matches cream for pain relief in clubfoot babies

NCT ID NCT04766684

Symptom relief Sponsor: Vanderbilt University Medical Center Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested two numbing methods for a common clubfoot procedure in infants: a needle-free jet injection that works in 1-2 minutes versus a topical cream that takes 30 minutes. Researchers measured pain using a standard scale, heart rate, and oxygen levels in 107 babies. The goal was to see if the faster jet injection provides equal or better pain relief without more side effects.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

107 people

The number who actually took part.

Started

Jun 2021

Finished

Aug 2024

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

Up to 6 weeks

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria * Clubfoot patients less than 6 weeks of age at start of casting * Patients requiring in-office percutaneous achilles lengthening (TAL) following serial casting Exclusion Criteria * Clubfoot patients greater than 6 weeks of age at the start of casting * Previous clubfoot treatment * Patients with a neuromuscular condition (spina bifida, caudal regression syndrome, arthrogryposis, etc.) * In-office TAL is not recommended by treating physician

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Conditions

The condition(s) this trial relates to.

agnosia clubfoot

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Clubfoot

Contacts and locations

Locations

  • Vanderbilt Children's Orthopaedics

    Nashville, Tennessee, 37232, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.