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Recruiting NCT07519863

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

Phase II Interventional Emergence Delirium in Pediatric Anesthesia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Midazolam + Ketamine, Dexmedetomidine (DEX).
Who it may be relevant to
Registry conditions: Emergence Delirium in Pediatric Anesthesia. Basic parameters: 3 years — 16 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Egypt
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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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

Detailed 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.

Interventions

  • Drug 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.
  • Drug 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.

Primary outcome measures

  • Incidence of emergence delirium [Time frame: within 30 minutes after end of anesthesia]
Secondary outcome measures (3)
  • Total Opiod requirments [Time frame: Perioperative period]
  • Hemodynamic stability [Time frame: Baseline (pre-sedation), intraoperative period (every 5 minutes), and up to 30 minutes postoperatively]
  • The duration of stay in PACU [Time frame: Within 30 minutes after the end of anesthesia, with assessment performed during recovery ( every 5 minutes)]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Egypt · 1 center
  • Ain Shams University — Cairo

Identifiers

NCT: NCT07519863 · FMASU MD389/2025

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗