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Cold and vibration may replace numbing cream for Kids' shots

NCT ID NCT03220555

Symptom relief Sponsor: Nantes University Hospital 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 14, 2026 · Last updated Sep 15, 2026 · Updated 1 time

Summary

Shots and blood draws cause pain and anxiety in children, and numbing creams take time to work. Researchers are testing a device that uses cold, vibration, and distraction to block needle pain. The trial compares this device with standard numbing cream in children aged 4 to 15 at vaccination centers. The goal is to see whether the device offers similar pain relief with fewer constraints for families and staff.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
a device that combines cold, vibration, and distraction to reduce needle pain
What this could lead to
If it works, vaccination centers could offer a needle-free option that eases pain from shots and blood draws without waiting for numbing cream to take effect.
What could go wrong
The device may not match the pain relief of numbing cream, and children who fear needles may still feel anxious. Results in a vaccination center may not apply to other medical settings.

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

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

220 people

The number who actually took part.

Started

Oct 2017

Finished

Sep 2018

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

4 to 15 years

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: Any child who: * requires a venipuncture or a vaccination in a vaccination center * is 4 to 15 years old * is affiliated to the public social security * speaks French or is assisted by an translator in the language of the child * has given his oral consent and whose parents have given it Exclusion Criteria: Any child who: * suffers from sickle cell anemia * has a contraindication to use lidocaine patch * requires a Bacille de Calmette et Guérin (BCG) vaccine or tuberculin test * takes part in another research * has already participated to this study for another nursing care. * refused to participate or whose parents refused * has neurological or psychiatric disorders * has a nerve damage or an abrasion of the skin in terms of puncture or injection area. * under trusteeship or guardianship (unaccompanied foreign minors).

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Conditions

The condition(s) this trial relates to.

common cold Pain

As listed by the trial registrant

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

Intravenous injections Vaccination

Contacts and locations

Locations

  • La Roche sur Yon University Hospital

    La Roche-sur-Yon, 85925, France

  • Le Mans University Hospital

    Le Mans, 72037, France

  • Nantes University Hospital

    Nantes, 44093, France

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