Effectiveness of Topical Morphine Use in Patients With Painful Neoplastic Wounds in the Breast and Head and Neck: Double Blind Randomized Clinical Trial - MorphineGEL
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 106
- 试验地点
- 1
- 主要终点
- Numeric pain rating scale
研究概览
简要总结
The goal of this clinical trial is to compare in compare pain reduction in patients with malignant wounds using morphine gel or lidocaine gel. The main question to be answered is:
• Does morphine gel offer better pain control in malignant wounds when compared to lidocaine gel? Participants will answer a questionnaire where they report a note for pain at the site of the malignant wound and then the dressing will be performed by a nurse from the research team. The patient and the nurse do not know which product is being used. At the end of the dressing, the patient answers a new questionnaire. This process will be carried out for 3 days.
The researchers will compare the intervention group (morphine gel) and the control group (lidocaine gel) and verify if there is a difference in pain reduction between the two products.
详细描述
Potential participants will be all patients with malignant wounds in the head and neck or breast region who meet the inclusion and exclusion criteria, forming the study population.
After signing the free and informed consent form, the intervention group will receive topical morphine based on hydrogel in the formulation of 10mg of morphine sulfate - intravenous solution (1 ml) with 8g of hydrogel and the control group will receive lidocaine in gel.
To ensure the quality and accuracy of the data, in addition to the safety of the research participants, face-to-face monitoring visits will be carried out by the team from the Representative Area of Clinical Research (ARPC)/INCA throughout the execution of this protocol.
After signing the TCLE by the patient and researcher, the completion of the clinical form will begin. The pharmacist of the research team responsible for the randomization will be contacted to inform the inclusion of the patient in the study. The research team doctor will be responsible for prescribing the medication to be used, be it morphine or lidocaine gel, with a view to release by the hospital pharmacy.
Both morphine gel and lidocaine gel will be prepared in a flow hood suitable for handling the medications.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Malignant neoplastic wound in breast or head and neck;
- •Malignant neoplastic wound with staging >= II;
- •KPS >=30%
- •Having at least 3 on the numerical pain rating scale (0-10);
- •Admission time equal to or greater than 48 hours.
- •Make use of systemic morphine.
排除标准
- •Wound with fistula;
- •Wound with extensive coagulation necrosis (>50% of wound area;
- •Exuding wound > 1 (PUSH Scale);
- •Bleeding wound >1 (VIBe Scale)
- •Ongoing radiotherapy on the wound.
研究组 & 干预措施
Morphine sulfate
Topical morphine with hydrogel base.
干预措施: Morphine Sulfate (Drug)
Lidocaine Hcl 2% jelly
2% lidocaine jelly
干预措施: Lidocaine Hcl 2% Jelly (Drug)
结局指标
主要结局
Numeric pain rating scale
时间窗: 3 days
The scale assesses the intensity of pain, where 0 means no pain and 10 means the most intense pain possible
次要结局
- General Comfort Questionnaire(3 days)
- Pain relief(3 days)
研究者
Daianny Arrais de Oliveira da Cunha
Principal Investigator
Instituto Nacional de Cancer, Brazil