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New nasal spray could replace needles for kids in pain

NCT ID NCT06364072

Symptom relief Sponsor: Cessatech A/S 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 a nasal spray containing two painkillers (sufentanil and ketamine) for children aged 1 to 17 with moderate to severe pain in the emergency room. The goal was to see if it is safe, tolerable, and effective. Results showed the spray reduced pain and was well-tolerated, with only mild side effects like sedation or nasal irritation.

What this could mean

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

Active substance
Sufentanil and Ketamine nasal spray
What this could lead to
If successful, this could provide a needle-free, fast-acting pain relief option for children in emergency settings.
What could go wrong
This is an early-phase study with only 155 participants, so larger trials are needed to confirm safety and effectiveness. Side effects like sedation or breathing issues are possible.

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 2/3

Runs two stages together: whether the treatment works, then large-scale confirmation.

Participants

155 people

The number who actually took part.

Started

May 2024

Finished

May 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

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

Ages

1 year 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: * Pediatric participant, age 1 year to 17 years * Attending an Emergency Department following an injury * Acute pain of moderate or severe intensity * Obtained informed consent by parent/guardian and assent from the child if possible and relevant (age dependent) Exclusion Criteria: * Participant showing abnormal nasal cavity/airway such as: 1. major septal deviation 2. evidence of previous nasal disease or surgery 3. current significant nasal congestion due to common cold * Has received treatment with sufentanil and/or ketamine during the last 72 hours * Known or suspected allergy to ketamine or sufentanil * Critical, life- or limb-threatening condition requiring immediate management

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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.

Pain

Contacts and locations

Locations

  • Birmingham Women's and Children's NHS Foundation Trust

    Birmingham, United Kingdom

  • Complejo Hospitalario Universitario de Santiago (CHUS)

    Santiago de Compostela, Spain

  • Hospital General Universitario Dr. Balmis

    Alicante, Spain

  • Hospital Sant Joan de Deu

    Barcelona, Spain

  • Royal London Hospital

    London, United Kingdom

  • Sheffield Children's Hospital

    Sheffield, United Kingdom

  • Universidad Autonoma de Madrid (UAM) - Hospital Universitario La Paz (HULP) -

    Madrid, Spain

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