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

• Status: Completed
• Trial end date: 2014-10-01
• Target enrollment: 0
• Participant gender: All

Summary

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"

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Oklahoma
• Treatments: Acetaminophen; Acetaminophen, hydrocodone drug combination; Fentanyl; Oxycodone

Criteria

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)