The Effect of Dormicum-Ketamine Versus Dexmedetomidine on Emergence Delirium During Deep Sedation… (NCT07519863) | Clinical Trial Compass
RecruitingPhase 2
The Effect of Dormicum-Ketamine Versus Dexmedetomidine on Emergence Delirium During Deep Sedation in Paediatric Burn Patients
Egypt60 participantsStarted 2025-11-20
Plain-language summary
The aim of this study is to compare the effects of dormicum-ketamine versus dexmedetomidine on postoperative emergence delirium in pediatric patients undergoing deep sedation for burn-related procedures
Who can participate
Age range
3 Years – 16 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Incidence of emergence delirium
Timeframe: within 30 minutes after end of anesthesia