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

Information source: University of Oklahoma
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Pain

Intervention: Fentanyl (Drug); Fentanyl (Drug); Oxycodone/acetaminophen (Drug); oxycodone/acetaminophen (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: University of Oklahoma

Official(s) and/or principal investigator(s):
Stephen H Thomas, MD MPH, Principal Investigator, Affiliation: University of Oklahoma
Annette O Arthur, PharmD, Study Director, Affiliation: University of Oklahoma


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"

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Supportive Care

Primary outcome: Pain Level

Secondary outcome:

Nausea level

Occurrence of adverse events

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.


Minimum age: 18 Years. Maximum age: 60 Years. Gender(s): Both.


Inclusion Criteria:

- pain sufficient to warrant medication stronger than acetaminophen (Tylenol) or


- 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)

Locations and Contacts

Hillcrest Medical Center Emergency Department, Tulsa, Oklahoma 74104, United States
Additional Information

Starting date: May 2011
Last updated: December 2, 2014

Page last updated: August 23, 2015

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