The Effect of Dormicum-Ketamine Versus Dexmedetomidine on Emergence Delirium During Deep Sedation in Paediatric Burn Patients
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Incidence of emergence delirium
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 3 Years 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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
研究组 & 干预措施
Midazolam - Ketamine Group
Drug
干预措施: Midazolam + Ketamine (Drug)
Dexmedetomidine
Drug
干预措施: Dexmedetomidine (DEX) (Drug)
结局指标
主要结局
Incidence of emergence delirium
时间窗: 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).
次要结局
- Total Opiod requirments(Perioperative period)
- Hemodynamic stability(Baseline (pre-sedation), intraoperative period (every 5 minutes), and up to 30 minutes postoperatively)
- The duration of stay in PACU(Within 30 minutes after the end of anesthesia, with assessment performed during recovery ( every 5 minutes))