Wounds and Injuries Clinical Trial
— MorphineGELOfficial title:
Effectiveness of Topical Morphine Use in Patients With Painful Neoplastic Wounds in the Breast and Head and Neck: Double Blind Randomized Clinical Trial - MorphineGEL
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.
Status | Recruiting |
Enrollment | 106 |
Est. completion date | April 2024 |
Est. primary completion date | March 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - 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. Exclusion Criteria: - 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. |
Country | Name | City | State |
---|---|---|---|
Brazil | National Cancer Institute | Rio De Janeiro |
Lead Sponsor | Collaborator |
---|---|
Instituto Nacional de Cancer, Brazil |
Brazil,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Numeric pain rating scale | The scale assesses the intensity of pain, where 0 means no pain and 10 means the most intense pain possible | 3 days | |
Secondary | Pain relief | Difference in the means of pain assessed by the numeric pain assessment scale before and after the intervention. | 3 days | |
Secondary | General Comfort Questionnaire | General comfort questionnaire with scores ranging from 48-192, where 48 reports the worst comfort measure and 192 the highest comfort level reported by the patient. | 3 days |
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