Midazolam + Ketamine: Participants will receive intravenous midazolam (0.05 mg/kg) combined with ketamine (1 mg/kg). Supplemental ketamine doses (0.5 mg/kg) will be administered as needed to maintain adequate deep sedation during burn-related procedures.
Dexmedetomidine (DEX): Participants will receive intravenous dexmedetomidine (loading dose 1 mcg/kg over 15 minutes, followed by infusion 0.5-1 mcg/kg/hour) adjusted to maintain adequate deep sedation during burn-related procedures.
Study 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
Eligibility
Sex
ALL
Min age
3 Years
Max age
16 Years
Healthy volunteers
No
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
Primary outcome measure(s)
Incidence of emergence delirium — within 30 minutes after end of anesthesia Incidence of emergence delirium within 30 minutes after the end of anesthesia, defined as a Pediatric Anesthesia Emergence Delirium (PAED) Scale score ≥ 10 at any assessment point.
The Pediatric Anesthesia Emergence Delirium (PAED) Scale is a validated instrument ranging from 0 to 20, where higher scores indicate more severe emergence delirium (worse outcome).
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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