Comparative Study Between Nalbuphine Versus Tramadol on Post Operative Analgesia in Abdominal Surgery on Pediatric Cancer Patient
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 128
- 试验地点
- 1
- 主要终点
- time to first rescue analgesia
研究概览
简要总结
In current study the investigators aim to compare between nalbuphine versus tramadol for post-operative pain control in abdominal surgeries in pediatric.
详细描述
Pain is an important and complex protective phenomenon. Good postoperative pain relief is important as it alleviates patient distress and aids a rapid, uncomplicated recovery.
Nalbuphine is a semi-synthetic opioid analgesic that belongs to the phenanthrene family. It is commonly used for pain management in children, but is associated with certain side effects such as respiratory and central nervous system depression, emesis, and pruritus due to its effect on µ2 receptors. Tramadol is a potent analgesic that binds to µ1 and µ2 receptors and enhances the inhibitory action of descending pain pathways. In contrast to other opioids, including nalbuphine, tramadol does not induce tolerance and is associated with reduced adverse effects.
Therefore, in this study, investigators will compare the efficacy of nalbuphine and tramadol for the management of postoperative pain in cancer children after abdominal surgeries.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Outcomes Assessor)
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
- •Participants will be children aged 3-12 years
- •American society of anesthesia (ASA) classification I-III.
- •scheduled for elective Abdominal surgery under general anesthesia
排除标准
- •child guardian refusal.
- •Allergy from Tramal or nalbuphine
- •Patient with previous chronic pain on opioids
研究组 & 干预措施
nalbuphine (group A)
group A (nalbuphine) will receive a single dose of nalbuphine (0.2 mg/kg) immediately after surgery to be repeated every 8 hours for the duration of the study (72 hours)
干预措施: Nalbuphine (Drug)
Tramadol (group B)
group B( Tramadol) will receive a single dose of tramadol (2 mg/kg) immediately after surgery to be repeated every 8 hours for the duration of the study (72 hours).
干预措施: Tramadol (Drug)
结局指标
主要结局
time to first rescue analgesia
时间窗: 72 hours
Time to first analgesic request( paracetamol)
次要结局
- Frequency of paracetamol consumption(72 hours)
- Wong-barker faces pain rating scale score(72 hours)
研究者
Norma Osama Abdalla Zayed
Lecturer of Anesthesia, Surgical ICU and Pain Management, National Cancer Institute, Cairo University
National Cancer Institute, Egypt