title: A phase II study on the efficacy and safety of procedural analgesia with fentanyl buccal tablet in cancer patients for the placement of indwelling central venous access systems.
abstract: BACKGROUND
  Pain in cancer patients is often related to oncologic therapies and diagnostic procedures. The placement of fully implantable venous access systems is a very common procedure in oncology patients. Local anaesthesia is the method most commonly used to overcome pain related to this surgical procedure, but the local anaesthetic may be unable to completely eradicate all pain. This study investigates the effectiveness and safety of fentanyl buccal tablet (FBT), administered by OraVescent® technology, in reducing procedural pain related to the placement of indwelling central venous access systems (Ports) in opioid-naïve cancer patients.
  
  
  METHODS
  Inpatients who required an indwelling vascular access (Port) were preoperatively assessed with a self-assessment questionnaire on anxiety and pain. A 100 μg FBT was administered 10 min before preparation of the operating field. A self-assessment scale for pain experienced during the procedure was administered at the end of the procedure. Vital signs and the presence of any side effects or bothersome symptoms were monitored during the procedure, at the end, and 4 h later.
  
  
  RESULTS
  From October 2012 to June 2014, 65 patients were enrolled in the study. A total of 61 (93.9 %) patients perceived no or a little pain during the procedure. Four patients (6.2 %) reported a lot of pain. No patient reported very severe pain. This data is significant in terms of the lower than expected presence of pain (Fisher test p = 0.0018) as assessed in our previous experience without procedural analgesia. The most common side effects of FBT was drowsiness, experienced by 28 patients at the end of the procedure (43.1 %), significantly reduced (p < 0.01) to 8 patients after 4 h (12.5 %). Nausea was present in 6 cases at the end of the procedure (9.2 %) and in 7 cases 4 h later (10.9 %). Vomiting was present in 3 cases at the end (4.7 %) and in 2 other patients after 4 h (7.8 %). No significant change of vital parameters was observed between the baseline and the subsequent measurements in all patients studied.
  
  
  CONCLUSIONS
  The significant improvement in the number of patients experiencing little or no pain, accompanied by a lower number of non-severe side effects, suggests that FBT is a valid, practical and safe method of procedural analgesia. It will be necessary to perform further studies, taking into account the need for standard antiemetic pre-medication to minimise the incidence of nausea and vomiting.
authors.affiliation: Pain Therapy and Palliative Care Unit, CRO Aviano National Cancer Institute, Aviano, Italy. rbortolussi@cro.it.
authors.forename: R
authors.initials: R
authors.lastname: Bortolussi
authors.affiliation: Psycho-Oncology Unit, CRO Aviano National Cancer Institute, Aviano, Italy.
authors.forename: P
authors.initials: P
authors.lastname: Zotti
authors.affiliation: Anaesthesia and Intensive Care Unit, CRO Aviano National Cancer Institute, Aviano, Italy.
authors.forename: M
authors.initials: M
authors.lastname: Matovic
authors.affiliation: Anaesthesia and Intensive Care Unit, CRO Aviano National Cancer Institute, Aviano, Italy.
authors.forename: A
authors.initials: A
authors.lastname: Morabito
authors.affiliation: Anaesthesia and Intensive Care Unit, CRO Aviano National Cancer Institute, Aviano, Italy.
authors.forename: C
authors.initials: C
authors.lastname: Bertuzzi
authors.affiliation: Anaesthesia and Intensive Care Unit, CRO Aviano National Cancer Institute, Aviano, Italy.
authors.forename: M
authors.initials: M
authors.lastname: Caserta
authors.affiliation: Anaesthesia and Intensive Care Unit, CRO Aviano National Cancer Institute, Aviano, Italy.
authors.forename: F
authors.initials: F
authors.lastname: Fabiani
authors.affiliation: Anaesthesia and Intensive Care Unit, CRO Aviano National Cancer Institute, Aviano, Italy.
authors.forename: A
authors.initials: A
authors.lastname: Fracasso
authors.affiliation: Anaesthesia and Intensive Care Unit, CRO Aviano National Cancer Institute, Aviano, Italy.
authors.forename: C
authors.initials: C
authors.lastname: Santantonio
authors.affiliation: Anaesthesia and Intensive Care Unit, CRO Aviano National Cancer Institute, Aviano, Italy.
authors.forename: C
authors.initials: C
authors.lastname: Zanier
authors.affiliation: Anaesthesia and Intensive Care Unit, CRO Aviano National Cancer Institute, Aviano, Italy.
authors.forename: A
authors.initials: A
authors.lastname: Roscetti
authors.affiliation: Epidemiology and Biostatistics Dept, CRO Aviano National Cancer Institute, Aviano, Italy.
authors.forename: J
authors.initials: J
authors.lastname: Polesel
authors.affiliation: Clinical Trials Office, Scientific Directorate, CRO Aviano National Cancer Institute, Aviano, Italy.
authors.forename: D
authors.initials: D
authors.lastname: Gussetti
authors.affiliation: Anaesthesia and Intensive Care Unit, CRO Aviano National Cancer Institute, Aviano, Italy.
authors.forename: S
authors.initials: S
authors.lastname: Bedin
authors.affiliation: Clinical Trials Office, Scientific Directorate, CRO Aviano National Cancer Institute, Aviano, Italy.
authors.forename: A M
authors.initials: AM
authors.lastname: Colussi
authors.affiliation: Anaesthesia and Intensive Care Unit, CRO Aviano National Cancer Institute, Aviano, Italy.
authors.forename: D
authors.initials: D
authors.lastname: Fantin
mesh_terms: D000278:Administration, Buccal; D000368:Aged; D000701:Analgesics, Opioid / Q000008:administration & dosage / Q000627:therapeutic use*; D062905:Central Venous Catheters / Q000009:adverse effects*; D005260:Female; D005283:Fentanyl / Q000008:administration & dosage / Q000627:therapeutic use*; D006801:Humans; D008297:Male; D008875:Middle Aged; D009369:Neoplasms / Q000188:drug therapy*; D059408:Pain Management / Q000009:adverse effects*; D013607:Tablets / Q000008:administration & dosage / Q000627:therapeutic use*
chemical_list: D000701:Analgesics, Opioid; D013607:Tablets; D005283:Fentanyl
keywords: Anaesthesia; Cancer; Pain