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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Stephen H. Thomas, MD MPH, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT00685295
First received: May 23, 2008
Last updated: December 17, 2016
Last verified: December 2016
  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
Drug: Lansoprazole
Drug: Oxycodone
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel 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 ]
    Time it took for subjects to achieve a pain score reduction of 2 units (on a 0 to 10 scale)

  • Pain Reduction [ Time Frame: 60 minutes ]
    Number of subjects who reached pain reduction. A subject was deemed to have reached pain reduction if there was a two-point drop in pain scale (0-10).


Secondary Outcome Measures:
  • Occurrence of Untoward Opioid Side Effects [ Time Frame: 120 minutes ]
    Subjects were monitored for any signs of untoward opioid side effects.


Enrollment: 60
Study Start Date: August 2008
Study Completion Date: February 2009
Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1 / Fentora

Intervention Group:

Subject receives:

  1. placebo oral/swallowed pill
  2. Fentanyl (Fentora) 100mcg rapidly dissolving transbuccal tablet
Drug: Fentanyl
Fentanyl rapid dissolving tablet 100mcg
Other Name: Fentora
Active Comparator: Arm 2 / Percocet/Prevacid

Active Comparator Group:

Subject receives:

  1. Oxycodone/APAP (Percocet) 5/325 mg oral/swallowed pill
  2. Lansoprazole 15 mg (Prevacid) comparator rapidly dissolving transbuccal tablet
Drug: Lansoprazole
lansoprazole 15mg rapidly dissolving tablet
Other Name: Prevacid SoluTab
Drug: Oxycodone
Oxycodone 5/325 mg tablet
Other Name: Percocet

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

INCLUSION:

  • 18-60 years of age
  • Present to ED with a chief complaint of extremity injury
  • Negative pregnancy test (urine or blood)
  • Clinician judges subject to need extremity radiography to rule out a fracture
  • Subjects must indicate that their pain is of sufficient severity to warrant treatment with a pain medication stronger than acetaminophen or aspirin.
  • Subject's treating ED provider is aware of, and approves, participation (i.e. participation cannot be allowed to impair provision of standard patient care).

EXCLUSION:

  • Treating provider judges that IV analgesia is required
  • Allergy to acetaminophen or to any opiate/opioid
  • Currently taking phenothiazines or CNS depressants (including alcohol), or if subject has taken MAO inhibitors or SSRIs within the past two weeks
  • Already taken or been administered opioid analgesia for their current injury
  • Chronic opioid therapy or if the subject (or their medical records) indicate a history of opioid abuse
  • Breastfeeding mothers
  • If subject is planning to drive home after their ED visit, or if they are judged for any other reason to be non-candidates for opioid therapy.
  • hypersensitivity to lansoprazole
  • phenylketonuria
  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

Locations
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
Principal Investigator: Stephen H Thomas, MD, MPH Massachusetts General Hospital
  More Information

Responsible Party: Stephen H. Thomas, MD MPH, Attending Physician, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00685295     History of Changes
Other Study ID Numbers: FAIRTOP
Study First Received: May 23, 2008
Results First Received: February 25, 2009
Last Updated: December 17, 2016
Individual Participant Data  
Plan to Share IPD: No
Plan Description: There is no plan to make individual participant data available to other researchers.

Keywords provided by Massachusetts General Hospital:
Emergency Department
acute

Additional relevant MeSH terms:
Fentanyl
Oxycodone
Acetaminophen, hydrocodone drug combination
Lansoprazole
Dexlansoprazole
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adjuvants, Anesthesia
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Anti-Ulcer Agents
Gastrointestinal Agents
Proton Pump Inhibitors
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 March 29, 2017