Pain, Fracture, Sprain | Fentanyl Administered Intraorally for Rapid Treatment of Orthopedic Pain

Pain, Fracture, Sprain research study

What is the primary objective of this study?

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

Who is eligible to participate?

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

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

Pain, Fracture, Sprain

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 rapid dissolving tablet 100mcg

Drug:Lansoprazolelansoprazole 15mg rapidly dissolving tablet

Drug:OxycodoneOxycodone 5/325 mg tablet

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.

Arm 1 / FentoraIntervention Group: Subject receives: placebo oral/swallowed pill Fentanyl (Fentora) 100mcg rapidly dissolving transbuccal tablet

Arm 2 / Percocet/PrevacidActive Comparator Group: Subject receives: Oxycodone/APAP (Percocet) 5/325 mg oral/swallowed pill Lansoprazole 15 mg (Prevacid) comparator rapidly dissolving transbuccal tablet

Study Status


Start Date: August 2008

Completed Date: February 2009

Phase: Phase 1/Phase 2

Type: Interventional


Primary Outcome: Time to Analgesia

Secondary Outcome: Occurrence of Untoward Opioid Side Effects

Study sponsors, principal investigator, and references

Principal Investigator: Stephen H Thomas, MD, MPH

Lead Sponsor: Massachusetts General Hospital


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