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Could a simple breath of ketamine ease Kids' pain in the ER?

NCT ID NCT03950817

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 looked at whether giving ketamine as a mist through a special inhaler can help reduce acute pain in children aged 7 to 17 in the emergency department. Researchers compared three different doses to see which works best and how quickly. The goal is to find a needle-free way to manage pain when an IV is not easy to start.

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 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

80 people

The number who actually took part.

Started

May 2019

Finished

Sep 2024

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

7 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: * Patients with ages between 7 and 17 presenting to the ED * with acute painful conditions; score of 5 or more on a standard 11- point (0 to 10) numeric rating scale. * traumatic and non-traumatic abdominal pain * flank pain * back ,pain * musculoskeletal pain, * vaso-occlusive painful crisis of sickle cell disease, and lacerations with a * Patients receiving oral acetaminophen and/or ibuprofen at triage prior to SDK administration Exclusion Criteria: * altered mental status, * GCS\<15, * allergy to ketamine, * pregnant patients, * weight greater than 100 kg, * heart rate \>180, * airway abnormalities ( congenital or acquired), absence of parent(s) at the time of consent, * closed head injury, * seizure disorder, * use of opioid analgesics, * schizophrenia or bipolar disorder

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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.

Contacts and locations

Locations

  • Maimonides Medical Center

    Brooklyn, New York, 11219, United States

More trials for these conditions

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