Phase 2
N=60
Fentanyl Administered Intraorally for Rapid Treatment of Orthopedic Pain
Pain, Fracture, Sprain
Bottom Line
View on ClinicalTrials.gov: NCT00685295 ↗Enrolled (actual)
60
Serious AEs
0.0%
Results posted
Feb 2017
Primary outcome: Primary: Time to Analgesia — 10; 35 minutes
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Fentanyl (Drug); Lansoprazole (Drug); Oxycodone (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Massachusetts General Hospital
- Primary completion
- Feb 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time to Analgesia |
10; 35 | — |
| PRIMARY Pain Reduction |
30; 24 | — |
| SECONDARY Occurrence of Untoward Opioid Side Effects |
0; 1 | — |
Summary
Assess whether transbuccal fentanyl provides more rapid relief of orthopedic pain, than does the comparator Percocet
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT00685295). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.