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

April 2, 2026 updated by: Ain Shams University
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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt
        • Recruiting
        • Ain Shams University
        • Contact:
        • Principal Investigator:
          • Hebatalla M Ahmed, Masters Degree

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Midazolam - Ketamine Group
Drug
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.
Experimental: Dexmedetomidine
Drug
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
within 30 minutes after end of anesthesia

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total Opiod requirments
Time Frame: Perioperative period
Reduction in perioperative opioid requirement (measured in µg/kg of fentanyl equivalent)
Perioperative period
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)
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)
The duration of stay in PACU
Within 30 minutes after the end of anesthesia, with assessment performed during recovery ( every 5 minutes)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ain Shams University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 20, 2025

Primary Completion (Estimated)

November 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

March 9, 2026

First Submitted That Met QC Criteria

April 2, 2026

First Posted (Actual)

April 9, 2026

Study Record Updates

Last Update Posted (Actual)

April 9, 2026

Last Update Submitted That Met QC Criteria

April 2, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FMASU MD389/2025

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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