Head and Neck Neoplasms
Conditions
Interventions
This is a double-blind, randomized controlled trial. Experimental group: 53 participants with painful malignant wounds on the breast or head and neck will receive topical morphine based on a hydrogel
Sponsors
Escola de Enfermagem Aurora de Afonso Costa
Instituto Nacional de Câncer José Alencar Gomes da Silva - Hospital do Câncer IV
Eligibility
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Patient enrolled in the unit; primary or metastatic breast or head and neck disease of any histological type; malignant neoplastic wound with stage II or greater; 18 years of age or older; karnofsky performance status greater than or equal to 30%; have at least 3 on the pain intensity scale; admission time of 48 hours or more; using systemic morphine
Exclusion criteria
Exclusion criteria: Fistulated wound; wound with extensive coagulation necrosis (more than 50% of the wound area); wound with exudation greater than 1 (pressure ulcer scale for healing); wound with bleeding greater than 1 (validated intraoperative bleeding scale); radiotherapy in progress in the wound
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Expected outcome 1: Pain intensity menasured by numeric rating scale (NRS). | — |
Secondary
| Measure | Time frame |
|---|---|
| Expected Outcome 3: Comfort measured through the General Comfort Questionnaire that varies scores from 48 to 192 points.;Expected Outcome 4: Systemic morphine dose reported as the total dose in milligrams used in the last 24 hours.;Expected Outcome 5: Incidence and classification of adverse events reported as mild, moderate, severe, or lethal.;Expected outcome 2: Mild relief of pain at baseline and end of study measured using the numeric rating scale (NRS). | — |
Countries
Brazil
Contacts
Public ContactDaianny da Cunha
Instituto Nacional de Câncer José Alencar Gomes da Silva - Hospital do Câncer IV
Outcome results
None listed