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

Completed · Phase 3

Conditions studied: Pain

In brief

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"

Key facts

Study ID

NCT01270659

Run by

University of Oklahoma

People needed

60

Starts

2011-05-01

Expected to finish

2014-10-01

Last updated by the study team

2017-06-20

Who can join

Age: 18 and older, up to 60. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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)

Where it is running

• Hillcrest Medical Center Emergency Department — Tulsa, Oklahoma, United States

Full record on ClinicalTrials.gov

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