Safety and Efficacy Study of Fentanyl Buccal Tablet Use in the Emergency Department for Isolated Extremity Injury (FAIRTOP II)

University of Oklahoma (OU)

Status and phase: Completed; Phase 3

Conditions: Pain

Treatments: Drug: Oxycodone/acetaminophen; Drug: Fentanyl; Drug: oxycodone/acetaminophen

Study type: Interventional

Funder types: Other

Identifiers

NCT01270659

1774

Details and patient eligibility

About

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"

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• pain sufficient to warrant medication stronger than acetaminophen (Tylenol) or aspirin
• only if Emergency Department provider approves
• a negative pregnancy test is required for participation for women of childbearing age

Exclusion criteria

• If treating provider determines intravenous analgesia is required
• allergy to acetaminophen or any opiate/opioid, or lansoprazole patients currently taking phenothiazines, CNS depressants (including alcohol), or if they have taken an monoamine oxidase inhibitor (MAOI) or selective serotonin reuptake inhibitor (SSRI) in the past two weeks
• if patient has already been administered an opioid analgesic for their current injury
• patients on chronic opioids therapy or a history of opioid abuse
• breastfeeding mothers
• patients who plan to drive home after their emergency department visit
• history of phenylketonuria (due to phenylalanine in the formulation of the lansoprazole solutab)

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

60 participants in 4 patient groups

Low-FBT

Experimental group

Description:

Subject will receive FBT and placebo at a low dose

Treatment:

Drug: Fentanyl

Drug: Fentanyl

High-FBT

Experimental group

Description:

Subject will receive the high dose regimen of FBT and a high dose placebo

Treatment:

Drug: Fentanyl

Drug: Fentanyl

Low control

Active Comparator group

Description:

Subject will receive active oxycodone/APAP 5/325 mg and lansoprazole solutab for the fentanyl "placebo"

Treatment:

Drug: Oxycodone/acetaminophen

High control

Active Comparator group

Description:

Subject will receive the higher dose of the active comparator, #2 oxycodone/APAP 5/325mg, and lansoprazole solutab for the fentanyl "placebo"

Treatment:

Drug: oxycodone/acetaminophen