Open Label Pilot Study of Gabapentin for the Treatment of Pruritus Caused by Burn Injuries in Children
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Pruritus score
研究概览
简要总结
Children with healing burns often suffer from pruritus that may continue for many months. Pruritus can be very distressing to the child and can interfere with sleep, activities of daily living, and rehabilitation therapy. Additionally, constant scratching of skin grafts may result in damage that requires further surgery, thus putting the patient at additional risk and adding to health care costs. Although the size of the burn injury is a risk factor for pruritus, almost 50% of patients with small burn injuries reported moderate or severe pruritus.
详细描述
Gabapentin has been shown to be effective for the treatment of pruritus in adult patients with brachioradial pruritus, uraemic pruritus and pruritus of unknown origin. Although the specific mechanism is unknown, the end result is the downregulation of excitatory neurotransmitter release and decrease in neuronal hyperexcitability.
The primary objective of this study is evaluating the effectiveness of gabapentin in reducing the severity of pruritus in children with burn injuries.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 6 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children with partial or deep thickness burn
- •Children receiving triple antihistamines for treatment of pruritus
- •Children with a pruritus score ≥ 2 (Appendix 1) despite triple antihistamine therapy
- •Children who are tolerating liquids by mouth or nasogastric tube
- •Exclusion Criteria
- •Children with a medical condition for which gabapentin is contraindicated including children who have demonstrated a hypersensitivity to gabapentin or any of the components of the formulation.
- •Children with seizure disorders
- •Children with a pre-existing behavioural or developmental disorder
- •Children with renal impairment
- •Children with severe burns requiring PICU admission
排除标准
- 未提供
研究组 & 干预措施
Gabapentin
干预措施: Gabapentin (Drug)
结局指标
主要结局
Pruritus score
时间窗: Daily until discharge
4-point scale validated in children 6 to 18 years of age, with additional descriptors from a similar scale used in adults
次要结局
- Quality of Life Score(Daily until discharge)
- Antihistamine use(Daily until discharge or cessation of antihistamines)
- Opioid Consumption(Daily until discharge or cessation of opioid intake)
研究者
Jason Hayes
Staff Anesthesiologist
The Hospital for Sick Children