A Randomized Double Blinded, Placebo-controlled Trial of IV Ondansetron to Prevent Pruritus in Children Who Receive Intrathecal Morphine
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 46
- 试验地点
- 1
- 主要终点
- Severity of Pruritus
研究概览
简要总结
This is a prospective randomized, double-blind, placebo-controlled study to compare the incidence and intensity of ITM-induced pruritus and nausea/vomiting using pre-emptive IV ondansetron, followed by scheduled Around The Clock (ATC) ondansetron vs. our control group, where pruritus and PONV are treated with PRN only medications.
详细描述
Pruritus is one of the most common and bothersome side effects of intrathecal morphine (ITM) in children, with a reported incidence of 30-60%. Clinicians, who have witnessed unbearable itching and scratching in their young patients after intrathecal morphine, may be reluctant to offer this effective pain control to future patients, for fear of these unpleasant sequelae. A study previously found a 40% incidence of pruritus in young children who received intrathecal morphine for major urologic surgery.
This is a prospective randomized, double-blind, placebo-controlled study to compare the incidence and intensity of ITM-induced pruritus and nausea/vomiting using pre-emptive IV ondansetron, followed by scheduled Around The Clock (ATC) ondansetron vs. control group, where pruritus and PONV are treated with PRN only medications.
Enrollment of 3-17 year olds who are undergoing urologic or orthopedic operative procedures who are scheduled to receive low dose (4-5 mcg/kg) intrathecal morphine for pain management.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Study drug (ondansetron/placebo) will be masked for all but the pharmacist
入排标准
- 年龄范围
- 3 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •3-17 years
- •weight </= 100kg
- •scheduled for urologic or orthopedic procedure necessitating intrathecal morphine
- •ability to use verbal or pictorial pain assessment tools and techniques
- •informed consent and (if applicable) assent
排除标准
- •Inability to use verbal or pictorial pain scoring scales
- •hypersensitivity to selective 5-HT receptor antagonists
- •diagnosed congenital long QT syndrome
- •severe hepatic impairment
- •pregnancy or nursing mothers
研究组 & 干预措施
Ondansetron IV
Ondansetron IV X1 intraoperatively (0.1 mg/kg in 5 mLs) Ondansetron IV X 4 (Q 6 hrs for 24 hrs) (0.1 mg/kg in 5 mLs)
干预措施: Ondansetron (Drug)
Placebo
Placebo Comparator: This arm will receive (in a blinded fashion) a volume-matched placebo intraoperatively X1 as well as IV every 6 hrs for 24 hours postoperatively. (X4)
干预措施: Placebo Comparator (Drug)
结局指标
主要结局
Severity of Pruritus
时间窗: 24 hours
number of participants who indicated mild pruritus (no treatment needed) or severe pruritus (treatment needed)
Incidence of Pruritus
时间窗: 24 hours
number of participants with any incidence of pruritus
次要结局
- Severity of Post Operative Nausea or Vomiting(24 hours)
- Incidence of Post Operative Nausea or Vomiting(24 hours)
研究者
Elizabeth Putnam
Assistant Professor
University of Michigan