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Needle-Free pain relief: nasal sprays tested for kids in emergency

NCT ID NCT06968546

Symptom relief Sponsor: Fondation Lenval 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 This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 tests two nasal sprays, sufentanil and ketamine, to see which works better for severe pain from injuries like broken bones in children aged 6 to 17. Both sprays are given in the emergency room along with standard care. The goal is to find a fast, needle-free way to ease pain without extra 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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 116 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Feb 2026

An estimate. Start dates often move.

Expected to finish

Mar 2028

An estimate. End dates often move.

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

6 to 17 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: * Children aged 6 to 17 years inclusive, under 18 years old, weighing more than 10kg, and requiring analgesia for the management of acute pain * Presenting with pain assessed as severe using a validated pain scale (VAS \> 6/10) * Acute traumatic lime injury * Pain caused by trauma, excluding thoracic trauma with dyspnea and abdominal pain * Obtaining written and signe informed consent from one of the two parents or legal guardians * Affiliation with a social security system * Hemodynamically stable * For post-menarche girls: negative urine pregnancy test and effective contraception, in accordance with national regulations Exclusion Criteria: * Patient in a state of immediate life-threatening distress * Parents who don't understand and/or don't speak French * Known hypersensitivity to opiods * Allergy to one of the study treatments * History of epilepsy or known psychiatric illness * History of respiratory, cardiac or renal insufficiency * Use of serotonergic antidepressants * Any child with an ongoing respiratory condition (asthma, laryngitis) * Thoracic trauma * Use of opioids within the 4 hours prior to arrival in the ermergency department * Any child with an ongoing respiratory condition (asthma, laryngitis) * Thoracic trauma * Use of opioids within the 4 hours prior to arrival in the ermergency department * History of head, abdominal, or spinal trauma * Confirmed pregnancy * History of toxic substance use * Facial or nasal trauma * Whithdrawal of informed consent from the parents or legal guardian

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Conditions

The condition(s) this trial relates to.

Acute Pain agnosia bone fracture injury Pain pain agnosia

As listed by the trial registrant

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

Acute pain Analgesia Fractures, bone Pain Pain management Traumatology Wounds and injury

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Hôpital lenval

    Nice, France, 06000, France

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