Safety and Efficacy Study of Fentanyl Buccal Tablet Use in the Emergency Department for Isolated Extremity Injury
| Status: | Completed |
|---|---|
| Conditions: | Chronic Pain |
| Therapuetic Areas: | Musculoskeletal |
| Healthy: | No |
| Age Range: | 18 - 60 |
| Updated: | 2/7/2015 |
| Start Date: | October 2011 |
| End Date: | March 2014 |
| Contact: | Annette O Arthur, PharmD |
| Email: | annette-arthur@ouhsc.edu |
| Phone: | 918-579-2362 |
Fentanyl Administered Intraorally for Rapid Treatment of Orthopedic Pain: The FAIRTOP II Trial
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"
in comparison to standard analgesia, to determine if the FBT allows for faster achievement
of "significant analgesia"
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.
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.
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)
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