Pain
Conditions
Keywords
Fentanyl buccal tablet
Brief 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
Detailed description
The subjects/patients will be asked if they would desire a low dose or high dose pain medication regimen. The low dose (low-FBT) group will receive FBT at a dose of 100 mcg, as well as an oral (pill) placebo preparation. The low dose (low-control) group will receive an inactive comparator (lansoprazole rapidly-dissolving buccal 15mg, FBT placebo) and a dose of 5/325 Percocet tablet (oxycodone/acetaminophen 5/325). The high dose (high-FBT) group will receive 200 mcg FBT plus 2 placebo tablets. The high dose (high-control) group will receive the FBT placebo and a dose of 2, 5/325 Percocet tablets.
Interventions
DRUGFentanyl
Fentanyl buccal tablet 100 mcg once
Oxycodone/acetaminophen 5/325 mg once
Oxycodone/acetaminophen tablet 5/325 mg, 2 tablets one time
Sponsors
University of Oklahoma
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Median Time to Significant Analgesia (at Least 2 Units Decrease in Pain Level) | 60 minutes | Median time (in minutes) to 2 units decrease in pain level after drug administration. Patients were asked to rate their pain at every 5 minutes intervals from 0 to 60 minutes post drug administration. The 10-point verbally administered numeric pain rating scale (NPRS) was used to have patients rate their level of pain on a scale of 0 (no pain) to 10 (worst pain ever). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Nausea Level | every 5 minutes for the first 60 minutes | Subjects' nausea level was recorded to determine how fentanyl buccal tablet compares to standard therapy in causing nausea. Treatment induced nausea and severity of nausea level was assessed. Nausea was assessed by a 10-point verbally administered scale. Patients rated their degree of nausea on a scale of 0 (no nausea) to 10 (worst nausea). At the beginning of the study, literature review found relatively little evidence guiding objective means to rate nausea, but there was some precedent for this approach (Warden C. Prehospital use of ondansetron reduces nausea and episodes of vomiting in adults and children over 12 years old \[abstract\]. Prehosp Emerg Care. 2007;11:132). |
| Number of Participants Experiencing Any Adverse Events | Full 2 hours of the study period | Occurrence of any adverse event. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Low-FBT Subject will receive FBT and placebo at a low dose
Fentanyl: Fentanyl buccal tablet 100 mcg once | 6 |
| High-FBT Subject will receive the high dose regimen of FBT and a high dose placebo
Fentanyl: Fentanyl buccal tablet 200 mcg once | 25 |
| Low Control Subject will receive active oxycodone/APAP 5/325 mg and lansoprazole solutab for the fentanyl placebo
Oxycodone/acetaminophen: Oxycodone/acetaminophen 5/325 mg once | 4 |
| High Control Subject will receive the higher dose of the active comparator, #2 oxycodone/APAP 5/325mg, and lansoprazole solutab for the fentanyl placebo
oxycodone/acetaminophen: Oxycodone/acetaminophen tablet 5/325 mg, 2 tablets one time | 25 |
| Total | 60 |
Baseline characteristics
| Characteristic | Low-FBT | High-FBT | Low Control | High Control | Total |
|---|---|---|---|---|---|
| Age, Categorical <=18 years | 1 Participants | 2 Participants | 0 Participants | 1 Participants | 4 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 5 Participants | 23 Participants | 4 Participants | 24 Participants | 56 Participants |
| Age, Continuous | 25.5 years STANDARD_DEVIATION 10.01 | 38.4 years STANDARD_DEVIATION 13.7 | 34.0 years STANDARD_DEVIATION 13.1 | 35.4 years STANDARD_DEVIATION 11.9 | 35.6 years STANDARD_DEVIATION 12.9 |
| Race/Ethnicity, Customized Race/Ethnicity American Indian | 0 Participants | 0 Participants | 1 Participants | 1 Participants | 2 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Black | 2 Participants | 10 Participants | 0 Participants | 7 Participants | 19 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Hispanic | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Race/Ethnicity White | 4 Participants | 14 Participants | 3 Participants | 17 Participants | 38 Participants |
| Region of Enrollment United States | 6 participants | 25 participants | 4 participants | 25 participants | 60 participants |
| Sex: Female, Male Female | 2 Participants | 9 Participants | 2 Participants | 13 Participants | 26 Participants |
| Sex: Female, Male Male | 4 Participants | 16 Participants | 2 Participants | 12 Participants | 34 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 6 | 0 / 25 | 0 / 4 | 0 / 25 |
| other Total, other adverse events | 1 / 6 | 9 / 25 | 3 / 4 | 10 / 25 |
| serious Total, serious adverse events | 0 / 6 | 0 / 25 | 0 / 4 | 0 / 25 |
Outcome results
Primary
Median Time to Significant Analgesia (at Least 2 Units Decrease in Pain Level)
Median time (in minutes) to 2 units decrease in pain level after drug administration. Patients were asked to rate their pain at every 5 minutes intervals from 0 to 60 minutes post drug administration. The 10-point verbally administered numeric pain rating scale (NPRS) was used to have patients rate their level of pain on a scale of 0 (no pain) to 10 (worst pain ever).
Time frame: 60 minutes
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Low-FBT | Median Time to Significant Analgesia (at Least 2 Units Decrease in Pain Level) | 15.0 minutes |
| High-FBT | Median Time to Significant Analgesia (at Least 2 Units Decrease in Pain Level) | 20.0 minutes |
| Low Control | Median Time to Significant Analgesia (at Least 2 Units Decrease in Pain Level) | 15.0 minutes |
| High Control | Median Time to Significant Analgesia (at Least 2 Units Decrease in Pain Level) | 15.0 minutes |
Secondary
Nausea Level
Subjects' nausea level was recorded to determine how fentanyl buccal tablet compares to standard therapy in causing nausea. Treatment induced nausea and severity of nausea level was assessed. Nausea was assessed by a 10-point verbally administered scale. Patients rated their degree of nausea on a scale of 0 (no nausea) to 10 (worst nausea). At the beginning of the study, literature review found relatively little evidence guiding objective means to rate nausea, but there was some precedent for this approach (Warden C. Prehospital use of ondansetron reduces nausea and episodes of vomiting in adults and children over 12 years old \[abstract\]. Prehosp Emerg Care. 2007;11:132).
Time frame: every 5 minutes for the first 60 minutes
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Low-FBT | Nausea Level | 0 Participants |
| High-FBT | Nausea Level | 0 Participants |
| Low Control | Nausea Level | 0 Participants |
| High Control | Nausea Level | 0 Participants |
Secondary
Number of Participants Experiencing Any Adverse Events
Occurrence of any adverse event.
Time frame: Full 2 hours of the study period
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Low-FBT | Number of Participants Experiencing Any Adverse Events | 1 Participants |
| High-FBT | Number of Participants Experiencing Any Adverse Events | 9 Participants |
| Low Control | Number of Participants Experiencing Any Adverse Events | 3 Participants |
| High Control | Number of Participants Experiencing Any Adverse Events | 10 Participants |