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

University of Oklahoma60 enrolled

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"

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

DOUBLE

Enrollment

Conditions

Pain

Interventions

FentanylDRUG

Fentanyl buccal tablet 100 mcg once

FentanylDRUG

Fentanyl buccal tablet 200 mcg once

Oxycodone/acetaminophenDRUG

Oxycodone/acetaminophen 5/325 mg once

oxycodone/acetaminophen

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 Years

Medical Language ↔ Plain English

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)

Locations (1)

Hillcrest Medical Center Emergency Department

Tulsa, Oklahoma, United States

Outcomes

Primary Outcomes

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

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).

Time frame: 60 minutes

Secondary Outcomes

Nausea Level

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).

Time frame: every 5 minutes for the first 60 minutes

Number of Participants Experiencing Any Adverse Events

Occurrence of any adverse event.

Time frame: Full 2 hours of the study period

Data from ClinicalTrials.gov

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