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

Phase 3

Completed

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.

Recruitment & Eligibility

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)

Arm && Interventions

Group	Intervention	Description
Low control	oxycodone/acetaminophen	Subject will receive active oxycodone/APAP 5/325 mg and lansoprazole solutab for the fentanyl "placebo"
High control	oxycodone/acetaminophen	Subject will receive the higher dose of the active comparator, #2 oxycodone/APAP 5/325mg, and lansoprazole solutab for the fentanyl "placebo"
Low-FBT	Fentanyl	Subject will receive FBT and placebo at a low dose
High-FBT	Fentanyl	Subject will receive the high dose regimen of FBT and a high dose placebo

Primary Outcome Measures

Name	Time	Method
Median Time to Significant Analgesia (at Least 2 Units Decrease in Pain Level)	60 minutes	Median time (in minutes) to 2 units decrease in pain level after drug administration. Patients were asked to rate their pain at every 5 minutes intervals from 0 to 60 minutes post drug administration. The 10-point verbally administered numeric pain rating scale (NPRS) was used to have patients rate their level of pain on a scale of 0 (no pain) to 10 (worst pain ever).

Secondary Outcome Measures

Name	Time	Method
Number of Participants Experiencing Any Adverse Events	Full 2 hours of the study period	Occurrence of any adverse event.
Nausea Level	every 5 minutes for the first 60 minutes	Subjects' nausea level was recorded to determine how fentanyl buccal tablet compares to standard therapy in causing nausea. Treatment induced nausea and severity of nausea level was assessed. Nausea was assessed by a 10-point verbally administered scale. Patients rated their degree of nausea on a scale of 0 (no nausea) to 10 (worst nausea). At the beginning of the study, literature review found relatively little evidence guiding objective means to rate nausea, but there was some precedent for this approach (Warden C. Prehospital use of ondansetron reduces nausea and episodes of vomiting in adults and children over 12 years old \[abstract\]. Prehosp Emerg Care. 2007;11:132).