Status:
COMPLETED
Fentanyl Administered Intraorally for Rapid Treatment of Orthopedic Pain
Lead Sponsor:
Massachusetts General Hospital
Conditions:
Pain, Fracture, Sprain
Eligibility:
All Genders
18-60 years
Phase:
PHASE1
PHASE2
Brief Summary
Assess whether transbuccal fentanyl provides more rapid relief of orthopedic pain, than does the comparator Percocet
Detailed Description
Patients will be initially deemed eligible for study consideration if, after MGH ED nursing triage, an X-ray is ordered for suspected isolated extremity injury and the triage acuity level is "Minor". ...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
August 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2009
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00685295
Start Date
August 1 2008
End Date
February 1 2009
Last Update
February 9 2017
Active Locations (1)
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1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114