Overview
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
Description
This prospective randomized controlled study aims to compare the effects of a midazolam-ketamine combination versus dexmedetomidine on postoperative emergence delirium in pediatric patients undergoing deep sedation for burn-related procedures. Eligible pediatric burn patients scheduled for elective dressing changes or minor interventions will be randomly assigned into two equal groups.
Group I (Midazolam-Ketamine group) will receive intravenous midazolam combined with ketamine for deep sedation.
Group II (Dexmedetomidine group) will receive intravenous dexmedetomidine-based sedation according to a standardized dosing protocol.
Standard monitoring will be applied throughout the procedure, and sedation depth will be assessed using a validated sedation scale to ensure comparable levels of deep sedation in both groups. Emergence delirium will be evaluated postoperatively using the Pediatric Anesthesia Emergence Delirium (PAED) scale during recovery.
The primary outcome will be the incidence of emergence delirium in the early postoperative period. Secondary outcomes will include hemodynamic stability, recovery profile, postoperative pain scores, need for rescue medications, and incidence of adverse events.
Eligibility
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
