The use of fentanyl buccal tablets for breakthrough pain by using doses proportional to opioid basal regimen in a home care setting

Abstract

The dose of rapid onset opioids to be given for breakthrough cancer pain (BTcP) is controversial. Dose proportional to the basal opioid regimen seem to be safe and effective in hospital units. However, data in other less protected settings, like home care, are lacking. The aim of this open-label study was to assess the efficacy and safety in a group of patients with BTcP followed at home, after giving a dose of fentanyl buccal tablets (FBT) proportional to the opioid basal regimen, skipping the steps for dose titration. Consecutive patients admitted to a home care program presenting BTcP episodes and receiving stable doses of opioids for background pain were selected. Data from four consecutive episodes of BTcP were collected. For each episode, patients were instructed to routinely collect changes in pain intensity and severe adverse effects when pain got severe (T0) and to reassess the same items 15 min after FBT, given as a rescue medication in doses proportional to the daily opioid doses used for background pain (T15). One hundred twenty episodes of BTcP were recorded in 30 patients. One hundred eight episodes were defined as successfully treated, while 12 episodes required a further administration of opioids. Pain intensity significantly decreased at T15 (p<0.001). In 95.5 and 90.8 % of episodes treated, there was a reduction in pain intensity of more than 33 and 50 %, respectively. No relevant adverse effects were recorded, even in older patients. This study suggests that FBT given in doses proportional to the basal opioid regimen for the management of BTcP is very effective and safe in clinical practice in the home care setting.

Intranasal Fentanyl Versus Fentanyl Pectin Nasal Spray for the Management of Breakthrough Cancer Pain in Doses Proportional to Basal Opioid Regimen

“…24 No preference for 1 of the 2 products was given by patients who received both delivery systems. The other important finding is that both treatments in doses proportional to the basal opioid dose used for background pain were effective as well as tolerable, confirming experience accumulated through the years and the findings of some controlled studies, [13][14][15][16][17][18][19][20][21][22][23][24] even when higher doses were used. Finally, despite a similar analgesic trend, FPNS had a major impact at the intervals taken into consideration.…”

“…For instance, the only existing controlled study performed using a fentanyl buccal tablet has evidenced that proportional doses are more effective than the dose titration approach, without higher risks of adverse effects, 22 confirming a series of open-label studies in which proportional doses were highly effective and well tolerated. [13][14][15][16][17][18][19][20][21][22][23][24][25] Finally, there is clinical legend suggesting that the rescue dose of opioids for BTP should be 10% of the daily dose of scheduled opioids. Several studies of proportional doses have shown that to produce meaningful and clinical analgesic effects, it is necessary to administer 15 to 20% of the daily dose.…”

Breakthrough pain and its treatment: critical review and recommendations of IOPS (Italian Oncologic Pain Survey) expert group

“…On 15th March 2010, the Italian government approved a new law (n. 38), with the intent to improve pain assessment and treatment, imposing physicians and nurses to register the characteristics of pain in any patient's chart. According to these new indications from the Minister of Health, a group of experts started a program to organize a national observatory for exploring these activities.…”

Research in Palliative Care: My Past, My Present, My Future

“…In a"real world" study reproducing a clinical scenario of patients receiving opioids for BTP, while the dose of oral opioids used as rescue medication was 18% of the around the clock opioid dose, for oral transmucosal fentanyl titrated to determine the effective dose, the rescue dose was about 35% of the around the clock dose [16], suggesting that titration process may provide even higher doses than those expected by using proportional doses to the basal regimen. For instance, the only existing controlled study, performed with fentanl buccal tablet, has evidenced that proportional doses are more effective than the dose titration approach, without higher risks of adverse effects [17], confirming a series of open-label studies performed by my group in which proportional doses were highly effective and well tolerated [18,19], even at home [20]. Large epidemiological studies of characterization of BTP by using a predefinite algorithm and comparison studies of ROOs, used in proportional doses, are ongoing.…”