Effect of Single Dose Dexmedetomidine Versus Midazolam on Emergence Agitation and Recovery Profile When Added to Ketamine for Procedural Sedation and Analgesia in Pediatric Patients Undergoing Bone Marrow Aspiration and Biopsy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- efficacy of drug mixture on procedural sedation and analgesia: Ramsay sedation score
研究概览
简要总结
Group I :The patients will receive midazolam intravenously (i.v.) in a dose of 0.05 mg/kg diluted by 50ml saline over 10 minutes using syringe pump plus 1 mg/kg ketamine (iv).
Group II : The patients will receive Dexmedetomidine intravenously (i.v.) in a dose of 2mic/kg diluted by 50ml saline over 10 minutes using syringe pump plus 1 mg/kg ketamine (iv).
The objective of this study to evaluate the clinical effects, adverse effects and recovery time of two different sedative agents (midazolam and Dexmedetomidine) combined with ketamine during conscious sedation for child patient with haematological cancer undergoing BMA &biopsy.
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
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 3 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All consecutive children with acute lymphoblastic leukemia undergoing bone marrow aspiration and biopsy.
- •Exclusion criteria:
- •previous sensitization or anaphylactic reaction to Dexmedetomidine, ketamine,and midazolam;
- •evidence of head injury,
- •raised intracranial or intraocular tension;
- •use of drugs known to interact with either study agent;
- •an American Society of Anesthesiologists (ASA) physical status score greater than
- •Also Patients with cardiovascular, respiratory, hepatic diseases and epilepsy will be excluded.
排除标准
- 未提供
研究组 & 干预措施
midazolam plus ketamine
干预措施: midazolam intravenous infusion of 0.05 mg/kg plus 1 mg/kg ketamine (Drug)
dexmedetomidine plus ketamine
干预措施: Dexmedetomidine intravenous infusion of 2mic/kg plus 1 mg/kg ketamine (Drug)
结局指标
主要结局
efficacy of drug mixture on procedural sedation and analgesia: Ramsay sedation score
时间窗: within the time of the procedure of bone marrow aspirate and biopsy
to assess efficacy of procedural sedation and analgesia with drug mixture;using Ramsay sedation score. Ramsay score 1. Nervous, agitated, and/or restless. 2. Cooperative, orientated, quite patient. 3. Only obeying orders. 4. Sleeping, hitting the glabella, and responding to high voice suddenly 5. Sleeping, hitting the glabella, and responding to high voice slowly 6. No response to any of these stimulations Dexemeditomidine and midazolam will be started 2 minutes before procedure through a peripheral venous cannula and continued as maintainance, then ketamine will be administered over 10-20 s aiming to achieve a sedation level of 3 or 4 on Ramsay scale to start the procedure.
次要结局
未报告次要终点
研究者
Ahmed H Othman
Assisstant professor of Anesthesia ICU and pain Relief
Assiut University