Effectiveness and Tolerance of Fentanyl Citrate in Painful Pain Induced During Diagnostic or Ther… (NCT03809455) | Clinical Trial Compass
WithdrawnPhase 2
Effectiveness and Tolerance of Fentanyl Citrate in Painful Pain Induced During Diagnostic or Therapeutic Examinations in Cancer Patients
Stopped: Study was cancelled by Sponsor.
0Started 2020-02-01
Plain-language summary
A phase II, prospective, multicentre, single-blinded, randomised study (when fentanyl citrate is used outside of its marketing authorisation) Patients will be enrolled in an observational cohort when the fentanyl citrate is used according to its marketing authorisation.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Age ≥18 years.
✓. Patients in follow up or being treated for cancer.
✓. Patients with cancer-related pain (area of pain located near primary tumor or metastatic lesions).
✓. Patients:
✓. not having received any opioid treatment (opioid naïve).
✓. or, treated for less than 7 days by a slow-releasing/extend-release opioid treatment; and/or by less than 60 mg per day of oral morphine, or less than 30 mg/day of oral oxycodone, or less than 8 mg/day of oral hydromorphone, or less than 25 µg/h of transdermal fentanyl.
✓. Patients need to have at least one of the following interventions, lasting between 25 and 45 minutes during which they will be request to not move:
✓. Radiotherapy session\*, including tomography (patients hospitalized or treated as outpatients).
Exclusion criteria
✕. Patients with contraindication for the administration of fentanyl citrate: severe respiratory depression or a severe obstructive pulmonary disease.
✕. Patients who have already participated in this study.
✕. Patients with a history of alcoholism or substance/drug dependence.
✕. Patients with an intravenous or subcutaneous opioid patient-controlled analgesic (PCA) pump.