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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Fentanyl Administered Intraorally for Rapid Treatment of Orthopedic Pain: The FAIRTOP II Trial

Conditions
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Pain

Intervention / Treatment
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* Drug: Fentanyl
* Drug: Fentanyl
* Drug: Oxycodone/acetaminophen
* Drug: oxycodone/acetaminophen


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Low-FBT<br>Subject will receive FBT and placebo at a low dose | Drug: Fentanyl<br>* Fentanyl buccal tablet 100 mcg once<br>* Other names: Fentora 100 mcg buccal tablet;|
| Experimental: High-FBT<br>Subject will receive the high dose regimen of FBT and a high dose placebo | Drug: Fentanyl<br>* Fentanyl buccal tablet 200 mcg once<br>* Other names: Fentora buccal tablet 200 mcg;|
| Active Comparator: Low control<br>Subject will receive active oxycodone/APAP 5/325 mg and lansoprazole solutab for the fentanyl placebo | Drug: Oxycodone/acetaminophen<br>* Oxycodone/acetaminophen 5/325 mg once<br>* Other names: Percocet 5/325;|
| Active Comparator: High control<br>Subject will receive the higher dose of the active comparator, #2 oxycodone/APAP 5/325mg, and lansoprazole solutab for the fentanyl placebo | Drug: oxycodone/acetaminophen<br>* Oxycodone/acetaminophen tablet 5/325 mg, 2 tablets one time<br>* Other names: Percocet 5/325;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Median Time to Significant Analgesia (at Least 2 Units Decrease in Pain Level) | 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). | 60 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Nausea Level | 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). | every 5 minutes for the first 60 minutes | 
| Number of Participants Experiencing Any Adverse Events | Occurrence of any adverse event. | Full 2 hours of the study period | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Fentanyl buccal tablet