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

ConditionEmergence Delirium in Pediatric Anesthesia
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age3-16
SponsorAin Shams University

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: Midazolam - Ketamine GroupExperimental treatment 1 intervention
Group B: DexmedetomidineExperimental treatment 1 intervention

Trial outcomes

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).

Time frame
within 30 minutes after end of anesthesia

Secondary outcomes

1

Total Opiod requirments

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

Time frame
Perioperative period
2

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
3

The duration of stay in PACU

The duration of stay in PACU

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

Other outcomes

Sponsors and contacts

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Ain Shams University

Lead sponsor

Source ClinicalTrials.gov
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