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New pain tablet could replace IV opioids in ERs

NCT ID NCT06917651

Symptom relief Sponsor: University Hospital, Clermont-Ferrand Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests a 30-microgram sublingual sufentanil tablet for treating moderate to severe pain from a single injury in the emergency department. 300 adults with pain scores of 4 or higher on a 0-10 scale will receive either the tablet or standard pain treatment. The goal is to see if the tablet works faster and better than usual care, without needing an IV.

What this could mean

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

Active substance
sublingual sufentanil 30 mcg tablet
What this could lead to
If it works, this could provide a faster, non-invasive way to manage severe pain in emergency settings without needing an IV.
What could go wrong
This is a single-center Phase 3 trial, so results may not apply everywhere. The drug is already approved, but it may not be clearly better than standard care and could cause side effects like drowsiness or nausea.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 300 people

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

Started

Apr 2025

Expected to finish

Apr 2027

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

18 years and older

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: * Adult patient * Patient with a pain rating on the Numerical Rating Scale (NRS) ≥ 4 * Pain of monotraumatic origin in the upper or lower limb * Glasgow Coma Scale = 15 * SaO2 \> 95% in ambient air Exclusion Criteria: * Polytrauma * Analgesic treatment within the 4 hours preceding admission (except paracetamol) * Woman of childbearing age without effective contraception, declaring pregnancy or at risk of pregnancy, breastfeeding woman, or positive pregnancy test at inclusion * Patient requiring intravenous access upon admission (e.g., displaced open fracture) * Contraindication or allergy to any of the molecules in the analgesia protocol * Refusal to participate * Known substance abuse or psychiatric disorders * Known oxygen dependence or COPD * Not affiliated with social security * Patient under guardianship, curatorship, deprived of liberty, or under legal protection * Patient who does not speak or read French

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Conditions

The condition(s) this trial relates to.

agnosia Pain

As listed by the trial registrant

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

Pain management

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

  • CHU de Clermont-Ferrand, Clermont-Ferrand

    RECRUITING

    France, France

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