RecruitingPhase 2NCT07519863

The Effect of Dormicum-Ketamine Versus Dexmedetomidine on Emergence Delirium During Deep Sedation in Paediatric Burn Patients


Sponsor

Ain Shams University

Enrollment

60 participants

Start Date

Nov 20, 2025

Study Type

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

Min Age: 3 YearsMax Age: 16 Years

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

DRUGMidazolam + 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.

DRUGDexmedetomidine (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.


Locations(1)

Ain Shams University

Cairo, Egypt

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NCT07519863


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