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

Overview

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 Title of Study: “Fentanyl Administered Intraorally for Rapid Treatment of Orthopedic Pain: The FAIRTOP II Trial”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Supportive Care
    • Masking: Double (Participant, Investigator)
  • Study Primary Completion Date: October 2014

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.

Interventions

  • Drug: Fentanyl
    • Fentanyl buccal tablet 100 mcg once
  • Drug: Fentanyl
    • Fentanyl buccal tablet 200 mcg once
  • Drug: Oxycodone/acetaminophen
    • Oxycodone/acetaminophen 5/325 mg once
  • Drug: oxycodone/acetaminophen
    • Oxycodone/acetaminophen tablet 5/325 mg, 2 tablets one time

Arms, Groups and Cohorts

  • Experimental: Low-FBT
    • Subject will receive FBT and placebo at a low dose
  • Experimental: High-FBT
    • Subject will receive the high dose regimen of FBT and a high dose placebo
  • Active Comparator: Low control
    • Subject will receive active oxycodone/APAP 5/325 mg and lansoprazole solutab for the fentanyl “placebo”
  • 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”

Clinical Trial Outcome Measures

Primary Measures

  • 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).

Secondary Measures

  • 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.

Participating in This Clinical Trial

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)

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 60 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University of Oklahoma
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Stephen H Thomas, MD MPH, Principal Investigator, University of Oklahoma
    • Annette O Arthur, PharmD, Study Director, University of Oklahoma

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