Ketamine and Hydromorphone PCA Analgesia for Antineoplastic-Induced Pediatric Mucositis
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- 24 hour hydromorphone consumption
研究概览
简要总结
The treatment of cancer in children may result in an extremely painful condition called oral mucositis when the cells lining the mouth are injured due to the cancer medication. Patients with this condition are often unable to take anything by mouth or to swallow their own saliva. This severe pain may last for as long as 2 weeks. A survey of our previous 22 patients showed high daily pain scores despite the use of intravenous (given through a small tube in a vein) opioid medications (family of pain relieving drugs, e.g. morphine and hydromorphone).
The purpose of this pilot study is to determine which of 3 concentrations of ketamine to combine with hydromorphone to provide the best pain relief with minimum side effects. The results from this study will allow us to do a larger study to compare the best concentration found from this study to standard treatment. If successful, this combination of ketamine and hydromorphone will also be used to treat other pain problems in children.
详细描述
The purpose of this observational pilot study is to evaluate the feasibility, efficacy and optimum ratio of a compounded mixture of HM-K administered parenterally by PCA in pediatric mucositis patients who have inadequate analgesia using conventional HM PCA.
An open-label study of 20 consecutive consenting/assenting subjects who meet the study criteria will be conducted. All patients who are eligible for the study will be approached for informed, written consent and subjects over age 7 will complete an assent form.
The subject will be examined by a pediatric oncology fellow/staff to determine the level of clinical severity of the mucositis using the Oral Mucositis Assessment Scale (OMAS) and World Health Organization Mucositis Scale.
A modified Colour Analogue Scale (mCAS) that was originally designed to evaluate pain intensity will be used to evaluate the self-report symptoms. The subject will then receive 24 hours of therapy using a compounded HM-K PCA solution.
Initial PCA prescription for the Background and Bolus will be set at the existing settings on the morning of recruitment as per the study entry criteria of minimum hourly use of 4 mcg/kg/hour of HM. The 1-hour Maximum will be set at 4 times the Background dose.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 5 Years 至 19 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pediatric oral mucositis due to anti-neoplastic therapy.
排除标准
- •Must not be receiving concurrent oral analgesics or sedatives such as acetaminophen, gabapentin, lorazepam, nabilone or clonidine.
研究组 & 干预措施
1
Ketamine and hydromorphone for patient-controlled relief in children's mucositis.
干预措施: Ketamine & hydromorphone (Drug)
结局指标
主要结局
24 hour hydromorphone consumption
次要结局
- Self-report symptom scores