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

Pain research study

What is the primary objective of this study?

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\"

Who is eligible to participate?

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)

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Pain

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Drug:FentanylFentanyl buccal tablet 100 mcg once

Drug:FentanylFentanyl buccal tablet 200 mcg once

Drug:Oxycodone/acetaminophenOxycodone/acetaminophen 5/325 mg once

Drug:oxycodone/acetaminophenOxycodone/acetaminophen tablet 5/325 mg, 2 tablets one time

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

Low-FBTSubject will receive FBT and placebo at a low dose

High-FBTSubject will receive the high dose regimen of FBT and a high dose placebo

Low controlSubject will receive active oxycodone/APAP 5/325 mg and lansoprazole solutab for the fentanyl "placebo"

High controlSubject will receive the higher dose of the active comparator, #2 oxycodone/APAP 5/325mg, and lansoprazole solutab for the fentanyl "placebo"

Study Status

Completed

Start Date: May 2011

Completed Date: October 2014

Phase: Phase 3

Type: Interventional

Design:

Primary Outcome: Median Time to Significant Analgesia (at Least 2 Units Decrease in Pain Level)

Secondary Outcome: Nausea Level

Study sponsors, principal investigator, and references

Principal Investigator: Stephen H Thomas, MD MPH

Lead Sponsor: University of Oklahoma

Collaborator:

More information:https://clinicaltrials.gov/show/NCT01270659

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