Conditions: Pain
Keywords: Fentanyl buccal tablet
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 60
Healthy volunteers: no

Brief summary:
The primary purpose of this study is to evaluate fentanyl buccal tablet (FBT) for analgesia in comparison to standard analgesia, to determine if the FBT allows for faster achievement of "significant analgesia"

Detailed description:
The subjects/patients will be asked if they would desire a low dose or high dose pain medication regimen. The low dose (low-FBT) group will receive FBT at a dose of 100 mcg, as well as an oral (pill) placebo preparation. The low dose (low-control) group will receive an "inactive comparator" (lansoprazole rapidly-dissolving buccal 15mg, " FBT placebo") and a dose of 5/325 Percocet tablet (oxycodone/acetaminophen 5/325). The high dose (high-FBT) group will receive 200 mcg FBT plus 2 placebo tablets. The high dose (high-control) group will receive the "FBT placebo" and a dose of 2, 5/325 Percocet tablets.

Arms:
arm 1: Subject will receive FBT and placebo at a low dose arm 2: Subject will receive the high dose regimen of FBT and a high dose placebo arm 3: Subject will receive active oxycodone/APAP 5/325 mg and lansoprazole solutab for the fentanyl "placebo" arm 4: Subject will receive the higher dose of the active comparator, #2 oxycodone/APAP 5/325mg, and lansoprazole solutab for the fentanyl "placebo"

Interventions: intervention 1: Fentanyl intervention 2: Fentanyl intervention 3: Oxycodone/acetaminophen intervention 4: oxycodone/acetaminophen
Intervention descriptions: intervention 1: Fentanyl buccal tablet 100 mcg once intervention 2: Fentanyl buccal tablet 200 mcg once intervention 3: Oxycodone/acetaminophen 5/325 mg once intervention 4: Oxycodone/acetaminophen tablet 5/325 mg, 2 tablets one time

Protocol document: