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Nasal spray vs injection: which ketamine route eases trauma pain faster?

NCT ID NCT05229055

Symptom relief Sponsor: University of Monastir 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 07, 2026 · Last updated Jul 08, 2026 · Updated 1 time

Summary

This trial tests whether ketamine given as a nasal spray works as well as ketamine injected under the skin for treating acute pain from limb injuries in the emergency department. About 1,000 adults with moderate to severe pain will be randomly assigned to one of the two methods. The study measures pain reduction after 30 minutes and tracks any serious side effects.

What this could mean

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

Active substance
Ketamine
What this could lead to
If successful, this could establish a fast, effective, and well-tolerated pain relief option for emergency patients with acute trauma.
What could go wrong
This is a mid-stage trial; results may not confirm superiority or non-inferiority of one route over the other. Side effects like sedation or dissociation are possible with ketamine.

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

1,000 people

The number who actually took part.

Started

Apr 2023

Finished

Dec 2025

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 to 60 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: * • Patients who presented to the ED with acute limb trauma pain with a visual analgesic scale (VAS) of 5 or more on a standard 11 point (0-10). * Pain was considered traumatic if it is reported as appearing immediately after the trauma and no anterior pain was described in the same limb. Exclusion Criteria: * Pregnancy/Breastfeeding * altered mental status (GCS\<15) * Allergy to ketamine or morphine * Weight less than 40 kg or greater than 100kg * Unstable vital signs (systolic blood pressure \<90 or \> 180mmHg, pulse rate\<50 or \>150bpm, and respiration rate \<10 or \>30 breath/min) * Medical history of acute head or eye injury * Medical history of seizure * Medical history of intracranial hypertension, * Medical history of chronic pain, * Medical history of severe renal or hepatic insufficiency. * Medical history of glaucoma * Alcohol or drug abuse * Psychiatric illness, * Recent (4 hours before) analgesic agent use.

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Conditions

The condition(s) this trial relates to.

Acute Pain

As listed by the trial registrant

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

Acute pain

Contacts and locations

Locations

  • university of Monastir

    Monastir, 5000, Tunisia

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