Post-Operative Pain
Conditions
Keywords
Adult post-operative inpatients who, are expected to require parenteral, opioid analgesia for at least 48, hours after open abdominal surgery, or hip/knee replacement surgery
Brief summary
The study is intended to show that the Sufentanil NanoTab PCA System is as effective as morphine intravenous patient-controlled analgesia (IV PCA) for treating pain after surgery. Each patient will use either the Sufentanil NanoTab PCA System or morphine IV PCA to treat their pain for at least 48 hours and up to 72 hours after surgery while in the hospital.
Interventions
15 mcg Sufentanil NanoTab dosed sublingually q 20 minutes as needed for pain for at least 48 hours and up to 72 hours
DRUGmorphine IV PCA
1 mg morphine administered IV q 6 minutes as needed for pain for at least 48 hours and up to 72 hours
Sponsors
Talphera, Inc
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Male or female patients who are 18 years or older * Patients who are scheduled to undergo an open abdominal surgery (including laparoscopic-assisted), total knee or total hip replacement surgery under general anesthesia or spinal anesthesia that does not include intrathecal opioids during the operation. * Post-surgical patients who have been admitted to the PACU and are expected to remain hospitalized and to have acute post-operative pain requiring parenteral opioids for at least 48 hours after surgery.
Exclusion criteria
* Patients who have taken an opioid for more than 30 consecutive days, at a daily dose of more than 15 mg of morphine (or equivalent), within the past 3 months prior to surgery (e.g. more than 3 doses per day of Vicodin®, Norco®, Lortab® with 5 mg hydrocodone per tablet). * Patients with an allergy or hypersensitivity to opioids * Female patients who are pregnant or breast-feeding
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient Global Satisfaction | 48 hours | Proportion of patients responding good or excellent at 48-hour global assessment of method of pain control |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Sufentanil NanoTab PCA System/15 mcg | 177 |
| Morphine IV PCA | 180 |
| Total | 357 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 13 | 18 |
| Overall Study | Lack of Efficacy | 13 | 16 |
| Overall Study | PCA no longer required or PCA problem | 3 | 7 |
| Overall Study | Withdrawal by Subject | 2 | 3 |
Baseline characteristics
| Characteristic | Morphine IV PCA | Sufentanil NanoTab PCA System/15 mcg | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 95 Participants | 92 Participants | 187 Participants |
| Age, Categorical Between 18 and 65 years | 85 Participants | 85 Participants | 170 Participants |
| Age, Continuous | 64 years STANDARD_DEVIATION 12.6 | 64 years STANDARD_DEVIATION 12.1 | 64 years STANDARD_DEVIATION 12.4 |
| Region of Enrollment United States | 180 participants | 177 participants | 357 participants |
| Sex: Female, Male Female | 108 Participants | 123 Participants | 231 Participants |
| Sex: Female, Male Male | 72 Participants | 54 Participants | 126 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 123 / 177 | 122 / 180 |
| serious Total, serious adverse events | 6 / 177 | 7 / 180 |
Outcome results
Primary
Patient Global Satisfaction
Proportion of patients responding good or excellent at 48-hour global assessment of method of pain control
Time frame: 48 hours
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Sufentanil NanoTab PCA System/15 mcg | Patient Global Satisfaction | 78.5 % patients reporting good or excellent |
| Morphine IV PCA | Patient Global Satisfaction | 65.6 % patients reporting good or excellent |
p-value: <0.00195% CI: [3.69, 22.11]one-sided, z-test
p-value: 0.007t-test, 2 sided