Opioid-Redox Study
Fjalë kyçe
Abstrakt
Përshkrim
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.
Datat
Verifikuar së fundmi: | 05/31/2020 |
Paraqitur së pari: | 04/01/2017 |
Regjistrimi i vlerësuar u dorëzua: | 04/01/2017 |
Postuar së pari: | 04/06/2017 |
Përditësimi i fundit i paraqitur: | 06/08/2020 |
Përditësimi i fundit i postuar: | 06/10/2020 |
Data e fillimit të studimit aktual: | 08/19/2021 |
Data e vlerësuar e përfundimit primar: | 11/20/2021 |
Data e vlerësimit të përfundimit të studimit: | 11/30/2022 |
Gjendja ose sëmundja
Faza
Grupet e krahëve
Krah | Ndërhyrja / trajtimi |
---|---|
Group A Morphin, Hydromorfon, Oxycodon | |
Group B Buprenorfin | |
Group C Fentanyl | |
Group D Opioid rotation |
Kriteret e pranimit
Moshat e pranueshme për studim | 18 Years Për të 18 Years |
Gjinitë e pranueshme për studim | All |
Metoda e marrjes së mostrës | Probability Sample |
Pranon Vullnetarë të Shëndetshëm | Jo |
Kriteret | Inclusion Criteria: - opiod therapy Exclusion Criteria: - active chemotherapy or radiotherapy |
Rezultati
Masat Kryesore të Rezultateve
1. Antioxidant enzymes [2 years]
Masat dytësore të rezultateve
1. Numerical pain scale [2 years]
2. Pain detetct score [2 years]