Phase 3
N=60
Safety and Efficacy Study of Fentanyl Buccal Tablet Use in the Emergency Department for Isolated Extremity Injury
Pain
Bottom Line
View on ClinicalTrials.gov: NCT01270659 ↗Enrolled (actual)
60
Serious AEs
0.0%
Results posted
Jun 2017
Primary outcome: Primary: Median Time to Significant Analgesia (at Least 2 Units Decrease in Pain Level) — 15.0; 20.0; 15.0; 15.0 minutes
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Fentanyl (Drug); Oxycodone/acetaminophen (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Oklahoma
- Primary completion
- Oct 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Median Time to Significant Analgesia (at Least 2 Units Decrease in Pain Level) |
15.0; 20.0; 15.0; 15.0 | — |
| SECONDARY Nausea Level |
0; 0; 0; 0 | — |
| SECONDARY Number of Participants Experiencing Any Adverse Events |
1; 9; 3; 10 | — |
Summary
The primary purpose of this study is to evaluate fentanyl buccal tablet (FBT) for analgesia in comparison to standard analgesia, to determine if the FBT allows for faster achievement of "significant analgesia"
Eligibility Criteria
Inclusion Criteria
- pain sufficient to warrant medication stronger than acetaminophen (Tylenol) or aspirin
- only if Emergency Department provider approves
- a negative pregnancy test is required for participation for women of childbearing age
Exclusion Criteria
- If treating provider determines intravenous analgesia is required
- allergy to acetaminophen or any opiate/opioid, or lansoprazole patients currently taking phenothiazines, CNS depressants (including alcohol), or if they have taken an monoamine oxidase inhibitor (MAOI) or selective serotonin reuptake inhibitor (SSRI) in the past two weeks
- if patient has already been administered an opioid analgesic for their current injury
- patients on chronic opioids therapy or a history of opioid abuse
- breastfeeding mothers
- patients who plan to drive home after their emergency department visit
- history of phenylketonuria (due to phenylalanine in the formulation of the lansoprazole solutab)
Data sourced from ClinicalTrials.gov (NCT01270659). 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.