Opioid-Redox Study
Słowa kluczowe
Abstrakcyjny
Opis
The process of the study, the choice of the patients, the collection and the processing of data A. Potential participants of study will be familiarized with the course of research in every detail before entering the study and after signing of an informed consent they will be examined by algesiologist. The patients will receive ID number generated by computer because of preserving of anonymity for the purpose of statistical processing of the data. Monitored clinical parameters: The current consumption of analgesics, examination of the type of pain (nociceptive vs. neuropathic - completed questionnaire for PainDetect, DN4 and LANSS Pain scales), demographic information (weight, height, age). Examination of biochemical parameters (ALT, AST, GMT, bilirubin, urea, creatinine, creatinine clearance, antioxidant enzymes and their substrates (glutathione peroxidase, glutathione reductase, catalase, superoxide dismutase, glutathione). These data will be entered into an online database. The statistical analysis of the activities of the enzymes will determine the confidence interval (CI) of 95%. Patients whose entrance numbers will be in this range will keep on in the study, remaining patients will be excluded. The patients who will keep on in study will be divided into four groups.
Group A: patients with chronic pain taking morphine, hydromorphone, oxycodone Group B: patients with chronic pain taking transdermal patch (Buprenorphine) Group C: patients with chronic pain taking transdermal patch (Fentanyl) Group D: opioid rotation B. The first inspection will be carried out 6 months after the beginning of taking of opioids for severe pain. During the first inspection, clinical and biochemical parameters will be examined same as during the input examination of the patient. The patient will fill out a questionnaire PainDetect, DN4 and LANSS Pain scales. C. The second inspection will be carried out 12 months after the beginning of taking of opioids for severe pain. During the second inspection, clinical and biochemical parameters will be examined same as during the previous two patient examinations. The patient will fill out a questionnaire PainDetect, DN4 and LANSS Pain scales.
Daktyle
Ostatnia weryfikacja: | 05/31/2020 |
Pierwsze przesłane: | 04/01/2017 |
Szacowana liczba przesłanych rejestracji: | 04/01/2017 |
Wysłany pierwszy: | 04/06/2017 |
Ostatnia aktualizacja przesłana: | 06/08/2020 |
Ostatnia opublikowana aktualizacja: | 06/10/2020 |
Rzeczywista data rozpoczęcia badania: | 08/19/2021 |
Szacowana data zakończenia podstawowej działalności: | 11/20/2021 |
Szacowana data zakończenia badania: | 11/30/2022 |
Stan lub choroba
Faza
Grupy ramion
Ramię | Interwencja / leczenie |
---|---|
Group A Morphin, Hydromorfon, Oxycodon | |
Group B Buprenorfin | |
Group C Fentanyl | |
Group D Opioid rotation |
Kryteria kwalifikacji
Wiek kwalifikujący się do nauki | 18 Years Do 18 Years |
Płeć kwalifikująca się do nauki | All |
Metoda próbkowania | Probability Sample |
Przyjmuje zdrowych wolontariuszy | Nie |
Kryteria | Inclusion Criteria: - opiod therapy Exclusion Criteria: - active chemotherapy or radiotherapy |
Wynik
Podstawowe miary wyników
1. Antioxidant enzymes [2 years]
Miary wyników wtórnych
1. Numerical pain scale [2 years]
2. Pain detetct score [2 years]