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Can a numbing cream soothe baby vaccine pain?

NCT ID NCT01802086

Symptom relief Sponsor: Beatrice Olsson Duse Source: ClinicalTrials.gov ↗

What the study statuses mean

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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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 whether Emla cream, a numbing cream, can reduce pain in 3-month-old babies during their first pneumococcal vaccination. 72 healthy babies were randomly given either Emla cream or a placebo cream before the shot. Pain was measured using a standard scale (FLACC) and crying time. The goal was to see if the cream makes vaccination less painful.

What this could mean

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

Active substance
Emla cream (lidocaine and prilocaine topical anaesthetic)
What this could lead to
If it works, this could offer a simple way to reduce pain for babies during routine vaccinations.
What could go wrong
This is a small, completed study with 72 infants, so results may not apply to all babies or other vaccines. The pain reduction may be modest.

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

72 people

The number who actually took part.

Start date

May 2013

Finished

Nov 2015

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

2 to 4 months

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: * Healthy children, born vaginally or by cesarean section after 37 weeks of gestation, who were not admitted to the neonatal unit. Children should only have been with the newborn screening performed routinely at the hospital. Exclusion Criteria: * Baby delivered by vacuum extraction or forceps. Children born before gestational week 37. Children in neonatal care and subjected to other testing than newborn screening. Shoulder dystocia. Children susceptible to methaemoglobinaemia in glucose 6-phosphate dehydrogenase deficiency, congenital or idiopathic methemoglobinemia. Children with atopic dermatitis.

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Conditions

The condition(s) this trial relates to.

Pain

As listed by the trial registrant

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

Children Pain

Contacts and locations

Locations

  • Healthcare center Mariefred/Strängnäs

    Mariefred, 64723, Sweden

More trials for these conditions

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