Comparison of Addition of Dexmedetomidine to Low Dose Morphine Versus Standard Dose of Morphine in Patiant Controlled Analgesia in Children Undergoing Pelvi Abdominal Exploration. A Prospective Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Post-operative pain intensity evaluation at (0,1, 2,6,12, 24h).
研究概览
简要总结
The treatment of perioperative pain in children has been a topic of great interest to pediatricians, pediatric surgeons, and anesthesiologists for many years. Opioids are the most common analgesics used to manage acute postoperative pain in children and adults
详细描述
Patient-controlled analgesia (PCA) permits patients to self-administer small doses of opioid analgesics intravenously or subcutaneously at frequent intervals. PCA is used in the management of moderate-to-severe pain. Patient-controlled analgesia (PCA) is now used in children as young as 5 yr for the treatment of postoperative pain.
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
- Single (Participant)
入排标准
- 年龄范围
- 8 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ASA I & II of both sex.
- •Age between 8 and 12 years.
- •Patients scheduled for exploration surgery under general anesthesia.
排除标准
- •Parents refused to give consent.
- •Patients with history of allergy to morphine or dexmedetomidine.
- •Mental disorders.
- •Unsuitability for extubation.
- •Comorbidities as cardiac, pulmonary and obstructive sleep apnea.
- •children with chronic opioid use for > 3 monthes
研究组 & 干预措施
standard dose morphine
children will receive 0.05 mg morphine /kg.as a bolus dose dissolved in 50 ml normal saline and 10 microgram/kg continuous infusion
干预措施: standard dose morphine (Drug)
low dose morphine and dexmedetomidine
children will receive 0.02 mg morphine /kg bolus dose plus 0.2 µg/kg dexmedetomidine dissolved in 50 ml normal saline and10 microgram/kg continuous infusion .
干预措施: low dose morphine plus dexmedetomidine (Drug)
结局指标
主要结局
Post-operative pain intensity evaluation at (0,1, 2,6,12, 24h).
时间窗: 24 hour
visual analogue score consists of a straight 10 cm line with the end points defining extreme limits between (0) no pain and (10) worst pain, the score is determined by measuring the distance between no pain and worst pain.
次要结局
- Total morphine consumption in 24h postoperative.(24 hour)
- respiratory depression(24 hour)
- nausea vomiting(24 hour)
- sedation(24 hour)
研究者
Mariana Soliman
Benisuef university
Beni-Suef University