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NCT Number: NCT07519863

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

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

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Key information

Conditions

Emergence Delirium in Pediatric Anesthesia

Age range

3 year–16 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Ain Shams University

Cairo, Egypt

Location status: Recruiting

Location contact

Hebatalla M Ahmed, Masters Degree

PRINCIPAL_INVESTIGATOR

Hebatalla M Ahmed, Masters degree

CONTACT

[email protected]

00201155859990

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. Incidence of emergence delirium

    Time frame: within 30 minutes after end of anesthesia

    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).

Secondary outcomes

  1. Total Opiod requirments

    Time frame: Perioperative period

    Reduction in perioperative opioid requirement (measured in µg/kg of fentanyl equivalent)

  2. Hemodynamic stability

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

    Hemodynamic stability will be assessed by measuring heart rate (HR) and mean arterial pressure (MAP) at predefined time points.

    Parameters will include:

    Mean HR and MAP values Incidence of bradycardia (HR < age-adjusted normal) Incidence of hypotension (MAP decrease >20% from baseline)

  3. The duration of stay in PACU

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

    The duration of stay in PACU

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Apr 9, 2026
Registry last updated
Apr 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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