Nalbuphine for the Treatment of Opioid Induced Pruritus in Children
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 134
- 试验地点
- 1
- 主要终点
- Pruritis intensity
研究概览
简要总结
Itching is a frequent and disturbing side effect of the use of pain medication such as morphine. In the post-operative period, it can be more distressing to pediatric patients than their pain. The current first line treatment, an antihistamine (Benadryl), has a low efficacy. This treatment causes sleepiness and may be dangerous when used in combination with other drugs.
Nalbuphine has analgesic properties similar to morphine as well as the ability to reverse some morphine-induced side effects, such as respiratory depression and itching. Nalbuphine has been used effectively for patients undergoing Caesarean sections. However, the effectiveness of nalbuphine in the pediatric population has not been investigated.
We want to determine the efficacy of nalbuphine in the treatment of itching after morphine for postoperative pain relief. We will use a novel method to measure the effect of the treatment using an intensity scale before and after the drug, to determine the intensity difference.
详细描述
PURPOSE Primary To determine the efficacy of nalbuphine (50 - 100 mcg/kg intravenously) in the treatment of opioid induced pruritus in a multi-center tertiary care pediatric patient population.
Secondary Determine the effect of treatment with nalbuphine on a subjects analgesia and level of sedation.
HYPOTHESIS
Primary Outcome:
Nalbuphine will be effective in the treatment of opioid induced pruritus; a 50% reduction in pruritus intensity will be considered clinically significant.
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, Investigator)
入排标准
- 年龄范围
- — 至 7 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Postoperative morphine administration
排除标准
- 未提供
结局指标
主要结局
Pruritis intensity
次要结局
- Pain, sedation