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Completed

NCT Number: NCT01270659

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

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"

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Key information

Conditions

Pain Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Hillcrest Medical Center Emergency Department

Tulsa, Oklahoma, 74104, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Fentanyl

Drug

Fentanyl buccal tablet 100 mcg once

Other names: Fentora 100 mcg buccal tablet

Oxycodone/acetaminophen

Drug

Oxycodone/acetaminophen 5/325 mg once

Other names: Percocet 5/325

Primary outcomes

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

    Time frame: 60 minutes

    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).

Secondary outcomes

  1. Nausea Level

    Time frame: every 5 minutes for the first 60 minutes

    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).

  2. Number of Participants Experiencing Any Adverse Events

    Time frame: Full 2 hours of the study period

    Occurrence of any adverse event.

Sponsors and collaborators

Lead sponsor

University of Oklahoma

Other

Registry information

Official study title

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

Acronym: FAIRTOP II

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
Jan 5, 2011
Registry last updated
Jun 20, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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