NCT07519863

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Ain Shams University · Academic / Other
• Sex: All
• Age: 3 Years – 16 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Emergence Delirium in Pediatric Anesthesia

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-11-20
• Primary completion: 2026-11-01
• Completion: 2026-12-01
• First posted: 2026-04-09
• Last updated: 2026-04-09

Locations

1 site across 1 country: Egypt