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

NCT07519863 | Recruiting Phase 2

• 1 other identifier: FMASU MD389/2025
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Emergence Delirium in Pediatric Anesthesia

Keywords

Dexmedetomidine; Burn Procedural sedation

Outcome Measures

Primary Outcomes (1)

• Incidence of emergence delirium

  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).

  within 30 minutes after end of anesthesia

Secondary Outcomes (3)

• Total Opiod requirments

  Perioperative period

• Hemodynamic stability

  Baseline (pre-sedation), intraoperative period (every 5 minutes), and up to 30 minutes postoperatively

• The duration of stay in PACU

  Within 30 minutes after the end of anesthesia, with assessment performed during recovery ( every 5 minutes)

Study Arms (2)

Midazolam - Ketamine Group

EXPERIMENTAL

Drug

Drug: Midazolam + Ketamine

Dexmedetomidine

EXPERIMENTAL

Drug

Drug: Dexmedetomidine (DEX)

Interventions

Midazolam + Ketamine DRUG

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.

Midazolam - Ketamine Group

Dexmedetomidine (DEX) DRUG

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.

Dexmedetomidine

Eligibility Criteria

• Age: 3 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain Shams University

Cairo, Egypt

RECRUITING

MeSH Terms

Interventions

Midazolam; Ketamine; Dexmedetomidine

Intervention Hierarchy (Ancestors)

Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 9, 2026
• First Posted: April 9, 2026
• Study Start: November 20, 2025
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: April 9, 2026

Record last verified: 2026-04

Locations

EG (1)