Fentanyl Administered Intraorally for Rapid Treatment of Orthopedic Pain (FAIRTOP)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2009 by Massachusetts General Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT00685295
First received: May 23, 2008
Last updated: February 9, 2009
Last verified: February 2009
  Purpose

Assess whether transbuccal fentanyl provides more rapid relief of orthopedic pain, than does the comparator Percocet


Condition Intervention Phase
Pain, Fracture, Sprain
Drug: Fentanyl rapid dissolving tablet 100mcg
Drug: lansoprazole 15mg rapidly dissolving tablet + Percocet PO
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Fentanyl Administered Intraorally for Rapid Treatment of Orthopedic Pain in the ED

Resource links provided by NLM:


Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • Time to analgesia [ Time Frame: 60 minutes ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Occurrence of untoward opioid side effects [ Time Frame: 120 minutes ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 100
Study Start Date: November 2008
Estimated Study Completion Date: December 2009
Estimated Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Subject receives placebo swallowed pill, and Fentora 100mcg rapidly dissolving transbuccal tablet
Drug: Fentanyl rapid dissolving tablet 100mcg
Fentanyl rapid dissolving tablet 100mcg will be given
Other Name: Fentora
Active Comparator: 2
Subject receives Percocet swallowed pill, and Prevacid comparator rapidly dissolving transbuccal tablet
Drug: lansoprazole 15mg rapidly dissolving tablet + Percocet PO
lansoprazole 15mg rapidly dissolving tablet + Percocet PO will be given

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion/Exclusion Criteria. The study population will comprise patients 18-60 years of age who present to the ED with a chief complaint of extremity injury, and who are triaged to the ED's "Minor Surgery" area. The trigger for evaluation for study eligibility will be the clinician-determined need for extremity radiography to rule-out fracture. To participate in the study, patients must meet the following inclusion and exclusion criteria:

  • Pediatric patients (age <18) will not be included in the study. There is insufficient evidence for Fentora's safety in this population, even in opioid-tolerant subjects, to justify Fentora's administration to the pediatric population in this first trial of Fentora in the ED setting.
  • Older adult patients over 60 years of age will not be included in the study. The clinical experience of the investigators is that fentanyl is more likely to cause respiratory depression in patients in older adults. The selection of 60 years of age as a cutoff is arbitrary, but was chosen to err on the clinically conservative side, and because the age of 60 has been used as a cutoff (for similar reasons of safety) in other trials of opioid analgesia.2 While the added risk to administration of fentanyl in older patients is difficult to quantify, it is noteworthy that one of the drug references commonly used by MGH ED clinicians (UpToDate, www.uptodate.com) states: "Elderly have been found to be twice as sensitive as younger patients to the effects of fentanyl."
  • To be included, patients must indicate that their pain is of sufficient severity to warrant treatment with a pain medication stronger than acetaminophen or aspirin. This approach has been utilized with good result in previous clinical trials of analgesia provision in the MGH ED. Allowing potential study subjects to "self-select" (rather than using a predefined pain scale minimum to arbitrarily define "significant pain") has the advantage of empowering potential study subjects. In practice, patient self-selection has not resulted in opioids being administered for what physicians perceive as minimal pain.3,4
  • Patients will be excluded from the study if the treating provider judges that IV analgesia is required.
  • Patients can only be included in the study if the treating ED provider is aware of, and approves, participation (i.e. participation cannot be allowed to impair provision of standard patient care).
  • Patients will be excluded from the study if they have allergy to acetaminophen or to any opiate/opioid.
  • Patients will be excluded if they are currently taking phenothiazines (hypotension risk) or CNS depressants (including alcohol), or if they have taken MAO inhibitors (which may potentiate fentanyl's effect) or SSRIs (possible serotonin syndrome) within the past two weeks.
  • Patients will be excluded if they have already taken or been administered, opioid analgesia for their current injury. Patients will also be excluded if they are on chronic opioid therapy, or if they (or the medical records) indicate a history of opioid abuse.
  • A negative pregnancy test (urine or blood) is required for participation. (Fentanyl is pregnancy category C, with a D categorization for late pregnancy.)
  • Breastfeeding mothers will be excluded from the study.
  • Patients will be excluded from the study if they are planning to drive home after their ED visit, or if they are judged for any other reason to be non-candidates for opioid therapy.
  • The only contraindication to a single-dose of the lansoprazole used as inactive placebo, is known hypersensitivity to the drug. Patients with this hypersensitivity will be excluded from the study.
  • Since the Prevacid SoluTab formulation to be used as the inactive placebo contains phenylalanine, subjects with phenylketonuria will be excluded from the study.

    1. Giannoidis P, Furlong A, Macdonald D, et al. Non-union of the femoral diaphysis: The influence of reaming and NSAIDs. J Bone Joint Surg 2000; 82B: 655-658.
    2. Gammaitoni AR, Galer BS, Bulloch S, et al. Randomized, double-blind, placebo-controlled comparison of the analgesic efficacy of oxycodone 10 mg/acetaminophen 325 mg versus controlled-release oxycodone 20 mg in postsurgical pain. J Clin Pharmacol. Mar 2003;43(3):296-304.
    3. Thomas SH, Silen W, Cheema F. Effects of morphine analgesia on diagnostic accuracy in ED patients with abdominal pain, J Amer Coll Surg 2003; 196: 18-31.
    4. Thomas SH, Borczuk P, Shackelford J, et al. Patient and physician agreement on abdominal pain severity and need for opioid analgesia. Am J Emerg Med. Oct 1999;17(6):586-590.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00685295

Contacts
Contact: Stephen H Thomas, MD MPH 617-726-7622

Locations
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Stephen h Thomas, MD MPH    617-726-7622    shthomas@partners.org   
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
Principal Investigator: Stephen H Thomas, MD, MPH Massachusetts General Hospital
  More Information

No publications provided

Responsible Party: Stephen H. Thomas MD MPH
ClinicalTrials.gov Identifier: NCT00685295     History of Changes
Other Study ID Numbers: FAIRTOP
Study First Received: May 23, 2008
Last Updated: February 9, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by Massachusetts General Hospital:
Emergency Department
acute

Additional relevant MeSH terms:
Sprains and Strains
Wounds and Injuries
Fentanyl
Acetaminophen, hydrocodone drug combination
Lansoprazole
Adjuvants, Anesthesia
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Analgesics, Opioid
Anti-Infective Agents
Anti-Ulcer Agents
Gastrointestinal Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Antirheumatic Agents

ClinicalTrials.gov processed this record on July 23, 2014