Safety and Efficacy Study of Fentanyl Buccal Tablet Use in the Emergency Department for Isolated Extremity Injury (FAIRTOP II)
|Pain||Drug: Fentanyl Drug: Oxycodone/acetaminophen Drug: oxycodone/acetaminophen||Phase 3|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Supportive Care
|Official Title:||Fentanyl Administered Intraorally for Rapid Treatment of Orthopedic Pain: The FAIRTOP II Trial|
- Median Time to Significant Analgesia (at Least 2 Units Decrease in Pain Level) [ Time Frame: 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).
- Nausea Level [ Time Frame: 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).
- Number of Participants Experiencing Any Adverse Events [ Time Frame: Full 2 hours of the study period ]Occurrence of any adverse event.
|Study Start Date:||May 2011|
|Study Completion Date:||October 2014|
|Primary Completion Date:||October 2014 (Final data collection date for primary outcome measure)|
Subject will receive FBT and placebo at a low dose
Fentanyl buccal tablet 100 mcg once
Other Name: Fentora 100 mcg buccal tablet
Subject will receive the high dose regimen of FBT and a high dose placebo
Fentanyl buccal tablet 200 mcg once
Other Name: Fentora buccal tablet 200 mcg
Active Comparator: Low control
Subject will receive active oxycodone/APAP 5/325 mg and lansoprazole solutab for the fentanyl "placebo"
Oxycodone/acetaminophen 5/325 mg once
Other Name: Percocet 5/325
Active Comparator: High control
Subject will receive the higher dose of the active comparator, #2 oxycodone/APAP 5/325mg, and lansoprazole solutab for the fentanyl "placebo"
Oxycodone/acetaminophen tablet 5/325 mg, 2 tablets one time
Other Name: Percocet 5/325
Please refer to this study by its ClinicalTrials.gov identifier: NCT01270659
|United States, Oklahoma|
|Hillcrest Medical Center Emergency Department|
|Tulsa, Oklahoma, United States, 74104|
|Principal Investigator:||Stephen H Thomas, MD MPH||University of Oklahoma|
|Study Director:||Annette O Arthur, PharmD||University of Oklahoma|