Evaluation of Symptoms, Complications and Side Effects of Adding Medications Continuously To Subcutaneous Infusion (Hypodermoclysis) In Home Care Hospice Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 27
- 试验地点
- 2
- 主要终点
- level of symptoms control
研究概览
简要总结
Background: Terminal patients are often unable to swallow and need medications to control symptoms. In these cases medications are administered continuously and subcutaneously by a syringe driver. A syringe driver is an expensive and sophisticated equipment to operate. Hypodermoclysis is a useful and easy alternative used in the homecare setting for hydration.
Objectives:
- To assess the level of symptoms control by the administration of morphine, metoclopramide and midazolam by hypodermoclysis versus by a syringe driver.
- To assess the complications and side effects of infusing these medications continuously by hypodermoclysis versus by a syringe driver.
Methods: Patients in the homecare setting who meet the criteria for parentral infusion and suffer: pain, vomit/nausea and/or agitation will be recruited for the study.
A double blind crossover methodology will be used. Each patient will serve as both intervention and control, and both patient and medical staff will be blinded to the medication route administration. A research nurse will administer the medications. Crossover will take place 48 hours thereafter. A research assistant will conduct evaluation of symptoms and side effects for a period of 4 days. A sample size of 27 patients will be included in the study (calculated for a significance level of 95% and power of 80%).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients in the home care unit that need medication/s continuously subcutaneously with symptoms level of 6 or higher on a visual analogue scale (VAS) for that symptom.
排除标准
- •Patients and caregivers that refuse to participate.
- •Every occasion when the infusion period will be less than 48 hours.
- •Every occasion when the patient and/or main care giver are not able to provide reliable information by the judgment of the medical staff person or research worker.
- •Patients that will need other medications subcutaneously that are not included in the study during their study treatment period.
结局指标
主要结局
level of symptoms control
次要结局
- complications and side effects