Bortolussi, R., Zotti, P., Matovic, M., Morabito, A., Bertuzzi, C., Caserta, M., . . . Roscetti, A. (2016). 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. Supportive Care in Cancer, 24, 1537–1543. 

To determine the effectiveness of using fentanyl buccal tablets (FBT) to reduce pain related to placing indwelling vascular access ports in opioid-naïve patients with cancer

Patients were assessed on anxiety and pain preoperatively. Ten minutes prior to the procedure, 100 mcg FBT was administered. Patients were assessed postoperatively on pain during the procedure. Side effects and symptoms were monitored during, after, and four hours after the procedure. Those with anesthesia-related nausea received one metoclopramide tablet one hour prior to the procedure, and those with extreme pain during the procedure received rescue therapy of 30 mg ketorolac or 20 drops of tramadol if allergic to NSAIDS/ASA.

• N = 65   
• AGE = 18 years and older
• MALES: 29.2%, FEMALES: 70.8%
• CURRENT TREATMENT: Not applicable
• KEY DISEASE CHARACTERISTICS: Histologically confirmed diagnosis of cancer
• OTHER KEY SAMPLE CHARACTERISTICS: Participants were 18 years or older, had indication for port as an inpatient, were cognitively intact, and had written informed consent. Exclusion factors: xerostomia; treatment for chronic cancer pain with opioids; history of nausea and vomiting to opioids or intolerance to fentanyl or FBT; chronic respiratory insufficiency; hepatic or renal function impairment.

• SITE: Not stated/unknown   
• SETTING TYPE: Inpatient    
• LOCATION: Inpatient

• PHASE OF CARE: Active antitumor treatment
• APPLICATIONS: Elder care

• Phase II pre-/poststudy design

• Four-point Likert-type scale for pain
• State-Trait Anxiety Inventory Form Y (STAI-Y)

• Significantly lower perception of pain in those treated with FBT than those not treated with FBT (p = 0.0018)
• Drowsiness reduced from after procedure to four hours post-procedure (p < 0.01)
• Vertigo reduced from after procedure to four hours post-procedure (p < 0.02)
• No significant findings with respect to nausea, vomiting, vital signs, and other side effects

Use of FBT pre-procedure to reduce pain perception is a plausible intervention for pain control in those receiving a port but is not without side effects. Further consideration to prevent or ameliorate side effects and further studies with a larger population should be considered.

• Small sample (< 100)
• Risk of bias (no blinding)
• Risk of bias (no random assignment)
• Risk of bias (no appropriate attentional control condition)  
• Risk of bias (sample characteristics)
• Unintended interventions or applicable interventions not described that would influence results
• Key sample group differences that could influence results
• Findings not generalizable
• These patients were compared to 2010–2011 patients, and so retrospective report and not knowing potential conditions impacting reporting is a weak area of this study

Nursing would need to be prepared for management of side effects and potential fall risk post-procedure. Side effects could require restructuring the postoperative environment to meet the needs of the patients or require follow-up beyond four hours.