Overview

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