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

Phase 2RecruitingNCT07519863

Ain Shams University60 enrolled

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

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Emergence Delirium in Pediatric Anesthesia

Interventions

Midazolam + KetamineDRUG

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.

Eligibility

Sex: ALLMin age: 3 YearsMax age: 16 Years

Medical Language ↔ Plain English

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

Locations (1)

Ain Shams University

Cairo, Egypt

RECRUITING

Outcomes

Primary Outcomes

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).

Time frame: within 30 minutes after end of anesthesia

Secondary Outcomes

Total Opiod requirments

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

Time frame: Perioperative period

Hemodynamic stability

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)

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)

Data from ClinicalTrials.gov

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