The Effect of Dormicum-Ketamine Versus Dexmedetomidine on Emergence Delirium During Deep Sedation in Paediatric Burn Patients
Ain Shams University
60 participants
Nov 20, 2025
INTERVENTIONAL
Conditions
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
Inclusion Criteria4
- 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 Criteria8
- 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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Interventions
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.
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.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT07519863