Fentanyl Administered Intraorally for Rapid Treatment of Orthopedic Pain

• Status: Completed
• Trial end date: 2009-02-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Massachusetts General Hospital
• Treatments: Acetaminophen, hydrocodone drug combination; Dexlansoprazole; Fentanyl; Lansoprazole; Oxycodone

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