Post-Operative Pain
Conditions
Keywords
In patient, post operative pain, Adult post-operative inpatients who are expected to require parenteral opioid analgesia for at least 48 hours after open abdominal surgery
Brief summary
The purpose of this study is to compare the efficacy and safety of the Sufentanil NanoTab PCA System/15 mcg to the Placebo Sufentanil NanoTab PCA System for the management of acute moderate to severe post-operative pain after open abdominal surgery.
Interventions
15 mcg Sufentanil NanoTab dosed sublingually every 20 minutes as needed for pain for up to 48 hours. Patient may elect to remain in study for up to 72 hours.
Placebo NanoTab dosed sublingually every 20 minutes as needed for pain for up to 48 hours. Patient may elect to remain in study for up to 72 hours.
Sponsors
Talphera, Inc
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
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) 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 |
|---|---|---|
| Time-weighted Summed Pain Intensity Difference (SPID) Over the 48-hour Study Period (SPID-48). | 48 hours | SPID-48 is the sum of the pain intensity difference (PID) over the 48 hour time period. A pain intensity score of 0 (no pain) to 10 (worse possible pain) is obtained before starting the study and throughout the 48 time period. The pain score at each assessment time is subtracted from the baseline pain score to provide the total sum score or SPID-48. A higher SPID-48 is better and indicates a reduction in pain intensity compared to the baseline score. The range of SPID48 scores were -232 to 326. Time-weighted SPID48 = ∑ \[T(i) - T(i-1)\] x PID(i), where T(0) = Time 0 (baseline), T(i) is the scheduled or unscheduled assessment time, and PID(i) is the PID score at time i for i=0 to 48 hours. Note: Active group n=114 and placebo group n=58, instead of active n=115 and placebo n=57, due to one active patient receiving placebo inadvertently. |
Countries
United States
Participant flow
Recruitment details
Recruitment period of 10 months - March 1, 2012 to December 28, 2012; Recruitment and screening occurred at clinical research centers and hospitals.
Pre-assignment details
Patients were excluded per protocol exclusion criteria at Screening as well as post surgery for certain issues including the following: 1. Patients who were not awake or stable 2. Patients with arterial oxygen saturation that couldn't be maintained at 95% or greater 3. Patients with uncontrollable vomiting
Participants by arm
| Arm | Count |
|---|---|
| Sufentanil NanoTab PCA System/15 mcg Sufentanil NanoTab PCA System/15 mcg : 15 mcg Sufentanil NanoTab dosed sublingually q 20 minutes as needed for pain for at least 48 hours. Patient may elect to remain in study for up to 72 hours | 114 |
| Placebo Sufentanil NanoTab PCA System Placebo Sufentanil NanoTab PCA System : Placebo NanoTab dosed sublingually q 20 minutes as needed for pain for at least 48 hours. Patient may elect to remain in study for up to 72 hours | 58 |
| Total | 172 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 6 | 4 |
| Overall Study | Lack of Efficacy | 20 | 18 |
| Overall Study | Patient ready for early discharge | 8 | 7 |
| Overall Study | Withdrawal by Subject | 2 | 2 |
Baseline characteristics
| Characteristic | Placebo Sufentanil NanoTab PCA System | Sufentanil NanoTab PCA System/15 mcg | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 22 Participants | 23 Participants | 45 Participants |
| Age, Categorical Between 18 and 65 years | 36 Participants | 91 Participants | 127 Participants |
| Age, Continuous | 57.4 years STANDARD_DEVIATION 14.9 | 54.2 years STANDARD_DEVIATION 13.5 | 55.2 years STANDARD_DEVIATION 14 |
| Region of Enrollment United States | 58 participants | 114 participants | 172 participants |
| Sex: Female, Male Female | 49 Participants | 79 Participants | 128 Participants |
| Sex: Female, Male Male | 9 Participants | 35 Participants | 44 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 26 / 114 | 15 / 58 |
| serious Total, serious adverse events | 1 / 114 | 0 / 58 |
Outcome results
Primary
Time-weighted Summed Pain Intensity Difference (SPID) Over the 48-hour Study Period (SPID-48).
SPID-48 is the sum of the pain intensity difference (PID) over the 48 hour time period. A pain intensity score of 0 (no pain) to 10 (worse possible pain) is obtained before starting the study and throughout the 48 time period. The pain score at each assessment time is subtracted from the baseline pain score to provide the total sum score or SPID-48. A higher SPID-48 is better and indicates a reduction in pain intensity compared to the baseline score. The range of SPID48 scores were -232 to 326. Time-weighted SPID48 = ∑ \[T(i) - T(i-1)\] x PID(i), where T(0) = Time 0 (baseline), T(i) is the scheduled or unscheduled assessment time, and PID(i) is the PID score at time i for i=0 to 48 hours. Note: Active group n=114 and placebo group n=58, instead of active n=115 and placebo n=57, due to one active patient receiving placebo inadvertently.
Time frame: 48 hours
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Sufentanil NanoTab PCA System/15 mcg | Time-weighted Summed Pain Intensity Difference (SPID) Over the 48-hour Study Period (SPID-48). | 105.60 Units on a scale | Standard Error 10.14 |
| Placebo Sufentanil NanoTab PCA System | Time-weighted Summed Pain Intensity Difference (SPID) Over the 48-hour Study Period (SPID-48). | 55.58 Units on a scale | Standard Error 13.11 |
p-value: 0.00195% CI: [19.89, 80.14]ANCOVA