Phase 3
Completed N=161
A Trial Evaluating the Efficacy and Safety of the Sublingual Sufentanil Tablet 30 mcg for Post-Operative Pain After Abdominal Surgery
Post-Operative Pain
Source: ClinicalTrials.gov NCT02356588 ↗
Enrolled (actual)
161
Serious AEs
1.2%
Results posted
Feb 2017
Primary outcomePrimary: Time-weighted Summed Pain Intensity Difference (SPID) Over the 12-hour Study Period (SPID12). — 25.84; 13.14 units on a scale
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
The purpose of this study is to compare the efficacy and safety of the sublingual Sufentanil Tablet (ST) 30 mcg to the sublingual Placebo Tablet (PT) for the short-term management of moderate-to-severe acute post-operative pain in patients after abdominal surgery.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time-weighted Summed Pain Intensity Difference (SPID) Over the 12-hour Study Period (SPID12). |
25.84; 13.14 | — |
| SECONDARY Time-weighted Summed Pain Intensity Difference (SPID) Over the 24-hour Study Period (SPID24). |
57.96; 37.28 | — |
| SECONDARY TOTPAR12 |
21.18; 15.36 | — |
| SECONDARY TOTPAR24 |
45.80; 35.45 | — |
| SECONDARY Time-weighted SPRID12 |
47.03; 28.62 | — |
| SECONDARY Time-weighted SPRID24 |
103.88; 73.05 | — |
| SECONDARY Patient Global Assessment |
80.4; 51.9 | — |
| SECONDARY Healthcare Professional Global Assessment |
80.4; 53.7 | — |
| SECONDARY Summed Pain Intensity Difference |
1.09; -0.37 | — |
| SECONDARY Analysis of Total Number of Doses Used During the 12-Hour Study Period in the ITT Population |
4.4; 4.7 | — |
| SECONDARY Analysis of Total Number of Doses Used During the 24-Hour Study Period in the ITT Population |
7.09; 6.40 | — |
| SECONDARY Summary of Number of Rescue Morphine Doses Used by Study Period in the ITT Population |
0.5; 2.1 | — |
Eligibility Criteria
Inclusion Criteria (additional criteria not specified here):
- Patients who are scheduled to undergo one of the following procedures with general anesthesia or spinal anesthesia that does not include intrathecal opioids during the operation:
- abdominoplasty
- open tension-free inguinal hernioplasty (Lichenstein repair with mesh)
- laparoscopic abdominal surgery
- Patients classified as American Society of Anesthesiologists (ASA) class I - III (Appendix I).
- Female patients of childbearing potential must be using an effective method of birth control at the time of screening visit
- Patients who are expected to have moderate-to-severe post-operative pain for at least 24 hours.
Exclusion Criteria (additional criteria not specified here):
- 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
- Patients who are currently taking monoamine oxidase inhibitors (MAOIs) or have taken MAOIs within 14 days of the first dose of study drug.
- Patients with current sleep apnea that has been documented by a sleep laboratory study or are on home continuous positive airway pressure (CPAP).
- Patients who previously have had abdominoplasty or have had an inguinal hernia repair on the same side.
Data sourced from ClinicalTrials.gov (NCT02356588). 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. Informational only — not medical advice.