Opioid-Redox Study
Klíčová slova
Abstraktní
Popis
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.
Termíny
Poslední ověření: | 05/31/2020 |
První předloženo: | 04/01/2017 |
Odhadovaná registrace vložena: | 04/01/2017 |
První zveřejnění: | 04/06/2017 |
Poslední aktualizace byla odeslána: | 06/08/2020 |
Poslední aktualizace zveřejněna: | 06/10/2020 |
Aktuální datum zahájení studie: | 08/19/2021 |
Odhadované datum dokončení primární: | 11/20/2021 |
Odhadované datum dokončení studie: | 11/30/2022 |
Stav nebo nemoc
Fáze
Skupiny zbraní
Paže | Intervence / léčba |
---|---|
Group A Morphin, Hydromorfon, Oxycodon | |
Group B Buprenorfin | |
Group C Fentanyl | |
Group D Opioid rotation |
Kritéria způsobilosti
Věky způsobilé ke studiu | 18 Years Na 18 Years |
Pohlaví způsobilá ke studiu | All |
Metoda vzorkování | Probability Sample |
Přijímá zdravé dobrovolníky | Ne |
Kritéria | Inclusion Criteria: - opiod therapy Exclusion Criteria: - active chemotherapy or radiotherapy |
Výsledek
Primární výsledná opatření
1. Antioxidant enzymes [2 years]
Měření sekundárních výsledků
1. Numerical pain scale [2 years]
2. Pain detetct score [2 years]