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 range3 Years – 16 Years
SexALL
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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
What they're measuring
1
Incidence of emergence delirium
Timeframe: within 30 minutes after end of anesthesia