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New study aims to calm burned kids after surgery

NCT ID NCT07519863

Symptom relief Sponsor: Ain Shams University 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study compares two sedation approaches—dormicum-ketamine versus dexmedetomidine—to see which better prevents emergence delirium (confusion and agitation) in children aged 3 to 16 with burns. Sixty kids undergoing burn dressing changes or minor procedures will be randomly assigned to one of the two drug regimens. The main goal is to measure how often delirium occurs within 30 minutes after sedation ends.

What this could mean

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

Active substance
Midazolam + Ketamine (dormicum-ketamine) and Dexmedetomidine
What this could lead to
If it works, this could point toward a better sedation method to reduce confusion and agitation in children after burn procedures.
What could go wrong
This is a small Phase 2 trial (60 participants), so results may not apply broadly. Both drugs have side effects like breathing problems or low blood pressure.

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 60 people

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

Started

Nov 2025

Expected to finish

Dec 2026

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

3 to 16 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: * Age from 3 to 16 years * Both sexes * Patients classified as American Society of Anesthesiologists (ASA) Physical -Status I-II * Patients scheduled for elective burn-related procedures (e.g., burn dressing changes or minor interventions) Exclusion Criteria: * Refusal or inability to provide written informed consent from parent or legal guardian * Known allergy or hypersensitivity to any of the study medications (midazolam, ketamine, or dexmedetomidine) * Presence of hepatic dysfunction * Presence of renal dysfunction * Presence of immunological or hematological disorders * History of epilepsy, developmental delay (mental retardation), or neurological deficits * Patients receiving or requiring high doses of inotropes and/or vasopressors intraoperatively or postoperatively * Preoperative hemodynamic instability, defined as uncontrolled hypertension, hypotension, or bradycardia

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Conditions

The condition(s) this trial relates to.

burn injury

As listed by the trial registrant

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

Emergence delirium in pediatric anesthesia

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

  • Ain Shams University

    RECRUITING

    Cairo, Egypt

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